Rekovelle

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
One multidose cartridge contains 12 micrograms follitropin delta* in 0.36 mL solution. 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
One multidose cartridge contains 36 micrograms follitropin delta* in 1.08 mL solution. 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
One multidose cartridge contains 72 micrograms follitropin delta* in 2.16 mL solution. 
 
One mL of solution contains 33.3 micrograms of follitropin delta* 
*recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by 
recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Solution for injection (injection). 
 
Clear and colourless solution with a pH of 6.0-7.0. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted 
reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm 
injection (ICSI) cycle. 
 
There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see 
section 5.1). 
 
4.2 Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of 
fertility problems. 
 
Posology 
The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian 
response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate 
number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation 
syndrome (OHSS). REKOVELLE is dosed in micrograms (see section 5.1). The dosing regimen is 
specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins. 



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For the first treatment cycle, the individual daily dose will be determined on the basis of the woman’s 
serum anti-Müllerian hormone (AMH) concentration and her body weight. The dose should be based 
on a recent determination of AMH (i.e. within the last 12 months) measured by the following 
diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4). The individual 
daily dose is to be maintained throughout the stimulation period. For women with AMH <15 pmol/L 
the daily dose is 12 micrograms, irrespective of body weight. For women with AMH ≥15 pmol/L the 
daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1). 
The dose is to be rounded off to the nearest 0.33 micrograms to match the dosing scale on the injection 
pen. The maximum daily dose for the first treatment cycle is 12 micrograms. 
For calculation of the REKOVELLE dose, the body weight is to be measured without shoes and 
overcoat just prior to start of stimulation. 
 
Table 1 Dosing regimen  

AMH (pmol/L) <15 15-16 17 18 19-20 21-22 23-24 25-27 28-32 33-39 ≥40 

Fixed daily dose 
of REKOVELLE  

12  0.19  0.18 0.17 0.16 0.15 0.14 0.13 0.12 0.11 0.10 

mcg mcg/kg 

The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer. If 
the AMH concentration is in ng/mL, the concentration should be converted to pmol/L by multiplying 
with 7.14 (ng/mL x 7.14 = pmol/L) before use. 
mcg: micrograms 
 
Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and 
continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on 
average is by the ninth day of treatment (range 5 to 20 days). A single injection of 250 micrograms 
recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final 
follicular maturation. In patients with excessive follicular development (of ≥25 follicles ≥12 mm), 
treatment with REKOVELLE should be stopped and triggering of final follicular maturation with hCG 
should not be performed. 
 
For subsequent treatment cycles, the daily dose of REKOVELLE should be maintained or modified 
according to the patient’s ovarian response in the previous cycle. If the patient had adequate ovarian 
response in the previous cycle without developing OHSS, the same daily dose should be used. In case 
of ovarian hypo-response in the previous cycle, the daily dose in the subsequent cycle should be 
increased by 25% or 50%, according to the extent of response observed. In case of ovarian hyper-
response in the previous cycle, the daily dose in the subsequent cycle should be decreased by 20% or 
33%, according to the extent of response observed. In patients who developed OHSS or were at risk of 
OHSS in a previous cycle, the daily dose for the subsequent cycle is 33% lower than the dose used in 
the cycle where OHSS or risk of OHSS occurred. The maximum daily dose is 24 micrograms. 
 
Patients with renal and hepatic impairment 
Safety, efficacy and pharmacokinetics of REKOVELLE in patients with renal or hepatic impairment 
have not been specifically studied in clinical trials. Although limited, data did not indicate a need for a 
different dosing regimen of REKOVELLE in this patient population (see section 4.4). 
 
Polycystic ovarian syndrome patients with anovulatory disorders 
Anovulatory patients with polycystic ovarian syndrome have not been studied. Ovulatory patients with 
polycystic ovaries have been included in clinical trials (see section 5.1). 
 
Elderly 
There is no relevant use of REKOVELLE in the elderly population.  
 
Paediatric population 
There is no relevant use of REKOVELLE in the paediatric population. 



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Method of administration 
The cartridge is designed to be used in conjunction with the REKOVELLE injection pen. 
REKOVELLE is intended for subcutaneous use, preferably in the abdominal wall. The first injection 
should be performed under direct medical supervision. Patients must be educated on how to use the 
REKOVELLE injection pen and to perform injections. Self-administration should only be performed 
by patients who are well motivated, adequately trained and have access to expert advice. 
 
For instructions on the administration with the REKOVELLE injection pen, see the ”Instructions for 
Use” supplied with the pen. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• tumours of the hypothalamus or pituitary gland 
• ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome 
• gynaecological haemorrhages of unknown aetiology (see section 4.4) 
• ovarian, uterine or mammary carcinoma (see section 4.4) 
 
In the following situations, treatment outcome is unlikely to be favourable, and therefore 
REKOVELLE should not be administered: 
• primary ovarian failure 
• malformations of sexual organs incompatible with pregnancy 
• fibroid tumours of the uterus incompatible with pregnancy 
 
4.4 Special warnings and precautions for use 
 
REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse 
reactions, and should only be used by physicians who are thoroughly familiar with infertility problems 
and their management. 
 
Gonadotropin therapy requires time commitment by physicians and supportive healthcare 
professionals, as well as the availability of appropriate monitoring facilities. Safe and effective use of 
REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with 
measurement of serum estradiol levels, on a regular basis. The dose of REKOVELLE is individualised 
for each patient to obtain an ovarian response with favourable safety/efficacy profile. There may be a 
degree of interpatient variability in response to FSH administration, with poor response to FSH in 
some patients and exaggerated response in others.  
 
Before starting treatment, the couple’s infertility should be assessed as appropriate and putative 
contraindications for pregnancy evaluated. In particular, patients should be evaluated for 
hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given. 
 
Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche for 
REKOVELLE dose determination is not recommended, as there currently is no standardisation of 
available AMH assays. 
 
Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be 
at risk of developing OHSS. Adherence to the REKOVELLE dose and regimen of administration and 
careful monitoring of therapy will minimise the incidence of such events. 
 



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Ovarian Hyperstimulation Syndrome (OHSS) 
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is 
more commonly seen in patients with polycystic ovarian syndrome and usually regresses without 
treatment. In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest 
itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex 
steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the 
peritoneal, pleural and, rarely, in the pericardial cavities. 
 
It is important to stress the value of careful and frequent monitoring of follicular development in order 
to reduce the risk of OHSS. The following symptoms may be observed in severe cases of OHSS: 
abdominal pain, discomfort and distension, severe ovarian enlargement, weight gain, dyspnoea, 
oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation 
may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, 
pleural effusions, hydrothorax, or acute pulmonary distress. Very rarely, severe OHSS may be 
complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic 
stroke or myocardial infarction. 
 
Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is 
administered to trigger final follicular maturation. Furthermore, the syndrome may be more severe and 
more protracted if pregnancy occurs. Therefore, in cases of ovarian hyperstimulation it is prudent to 
withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for 
at least 4 days. OHSS may progress rapidly (within 24 hours to several days) to become a serious 
medical event. It most often occurs after hormonal treatment has been discontinued. Also, as a 
consequence of the hormonal changes during pregnancy, late development of OHSS can occur. 
Because of the risk of developing OHSS patients should be followed for at least two weeks after 
triggering of final follicular maturation.  
 
Thromboembolic events 
Women with recent or ongoing thromboembolic disease or women with generally recognised risk 
factors for thromboembolic events, such as personal or family history, severe obesity (body mass 
index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic 
events, during or following treatment with gonadotropins. Treatment with gonadotropins may further 
increase the risk for aggravation or occurrence of such events. In these women, the benefits of 
gonadotropin administration need to be weighed against the risks. It should be noted however that 
pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events. 
 
Ovarian torsion 
Occurrence of ovarian torsion has been reported for ART cycles. It may be associated with other risk 
factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, 
previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood 
supply can be limited by early diagnosis and immediate detorsion. 
 
Multiple pregnancy 
Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes. In patients 
undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of 
embryos replaced, their quality and the patient age, although twin pregnancy can in rare occasions 
develop from single embryo transfers. The patients should be advised of the potential risk of multiple 
births before starting treatment. 
 
Pregnancy loss 
The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled 
ovarian stimulation for ART than following natural conception. 
 
Ectopic pregnancy 
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is 
obtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancy 
after ART has been reported to be higher than in the general population. 



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Reproductive system neoplasms 
There have been reports of ovarian and other reproductive system neoplasms, both benign and 
malignant, in women who have undergone multiple treatment regimens for infertility treatment. It is 
not established whether or not treatment with gonadotropins increases the risk of these tumours in 
infertile women. 
 
Congenital malformation 
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous 
conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, 
sperm characteristics) and multiple pregnancy. 
 
Other medical conditions 
Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment 
with REKOVELLE. 
 
Renal and hepatic impairment 
REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.  
 
Sodium content 
REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed with REKOVELLE. Clinically significant interactions 
with other medicinal products have neither been reported during REKOVELLE therapy, nor are 
expected.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
REKOVELLE is not indicated during pregnancy. No teratogenic risk has been reported, following 
controlled ovarian stimulation, in clinical use with gonadotropins. There are no data from the 
inadvertent exposure to REKOVELLE in pregnant women. Studies in animals have shown 
reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans 
(section 5.3).  
 
Breast-feeding 
REKOVELLE is not indicated during breastfeeding. 
 
Fertility 
REKOVELLE is indicated for use in infertility (see section 4.1). 
 
4.7 Effects on ability to drive and use machines 
 
REKOVELLE has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
The most frequently reported adverse reactions during treatment with REKOVELLE are headache, 
pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue. The frequency of these 
adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical 
trials.  
 



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Tabulated list of adverse reactions 
The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the 
pivotal clinical trials according to MedDRA system organ class and frequency as follows: common 
(≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse 
reactions are presented in order of decreasing seriousness. 
 
Table 2 Adverse reactions in pivotal clinical trials 

System Organ Class Common  (≥1/100 to <1/10) 
Uncommon  
(≥1/1,000 to <1/100) 

Psychiatric disorders  Mood swings 
 

Nervous system disorders Headache Somnolence  
Dizziness 
 

Gastrointestinal disorders Nausea Diarrhoea 
Vomiting 
Constipation 
Abdominal discomfort 
 

Reproductive system and breast 
disorders 

OHSS 
Pelvic pain 
Adnexa uteri pain 
Pelvic discomfort 

Vaginal haemorrhage 
Breast pain 
Breast tenderness 
 

General disorders and 
administration site conditions 

Fatigue  

 
Description of selected adverse reactions 
OHSS is an intrinsic risk of the ovarian stimulation. Known gastrointestinal symptoms associated with 
OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea. Ovarian 
torsion and thromboembolic events are known to be rare complications of ovarian stimulation 
treatment (see section 4.4).  
 
Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin 
therapy (see section 5.1). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see 
section 4.4). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, 
ATC code: G03GA10 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Mechanism of action 
The most important effect resulting from parenteral administration of FSH is the development of 
multiple mature follicles. 
 
Follitropin delta is a recombinant human FSH. The amino acid sequences of the two FSH subunits in 
follitropin delta are identical to the endogenous human FSH sequences. Because follitropin delta is 
produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and 
follitropin beta. 
 
Pharmacodynamic effects 
Following daily administration of equal IU doses of REKOVELLE and follitropin alfa as determined 
in the rat in vivo bioassay (Steelman-Pohley assay), higher ovarian response (i.e. estradiol, inhibin B 
and follicular volume) was observed in patients after administration of REKOVELLE compared to 
follitropin alfa. As the rat bioassay might not fully reflect the potency of the FSH in REKOVELLE in 
humans, REKOVELLE is dosed in micrograms and not in IU.  
 
The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH 
concentration. Conversely, increasing body weight leads to a decrease in the number of oocytes 
retrieved (only clinically relevant for REKOVELLE doses below 12 micrograms). The resulting 
REKOVELLE dosing regimen is in section 4.2. 
 
Clinical efficacy and safety 
The ESTHER-1 trial was a randomised, assessor-blinded, controlled trial in 1,326 IVF/ICSI patients. 
The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is 
established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to 
follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days 
followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH 
antagonist protocol. The patients were up to 40 years of age and had regular menstrual cycles 
presumed to be ovulatory. Single blastocyst transfer on day 5 was compulsory with the exception of 
patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts 
were available. The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation 
rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and 
number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts 
transferred, respectively. 
 
The trial demonstrated that REKOVELLE was at least as effective as follitropin alfa in terms of 
ongoing pregnancy rate and ongoing implantation rate, as shown in Table 3.  
  
Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial  
 REKOVELLE in an 

individualised dosing 
regimen  
(N=665) 

Follitropin alfa  
 
  
(N=661) 

Difference [95% CI] 

Ongoing pregnancy rate  30.7% 31.6% -0.9% [-5.9%; 4.1%] 
Ongoing implantation rate  35.2% 35.8% -0.6% [-6.1%; 4.8%] 
Population: all randomised and exposed  
 
The impact of the AMH-based dosing regimen of REKOVELLE was also assessed in secondary 
endpoints, such as ovarian response and OHSS risk management. 
 
In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with 
REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa 
(N=643) at a starting dose of 150 IU followed by dose adjustments.  
 



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Among patients with AMH ≥15 pmol/L, the ovarian response with REKOVELLE (N=355) and 
follitropin alfa (N=353), respectively, was as follows: mean number of oocytes retrieved 11.6 ± 5.9 
and 13.3 ± 6.9, and proportion of patients with ≥20 oocytes 10.1% (36/355) and 15.6% (55/353). 
 
In ovulatory patients with polycystic ovaries, the incidence of early moderate/severe OHSS and/or 
preventive interventions for early OHSS was 7.7% with REKOVELLE and 26.7% with follitropin 
alfa.  
 
Safety – immunogenicity 
Anti-FSH antibodies were measured pre-dosing and post-dosing in patients undergoing up to three 
repeated treatment cycles with REKOVELLE (665 patients in cycle 1 in the ESTHER-1 trial as well 
as 252 patients in cycle 2 and 95 patients in cycle 3 in the ESTHER-2 trial). The incidence of anti-FSH 
antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in 
cycle 3. These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure 
to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies 
after treatment with follitropin alfa. In all patients with anti-FSH antibodies, titres were undetectable 
or very low and without neutralising capacity. Repeated treatment with REKOVELLE of patients with 
pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not 
associated with decreased ovarian response, and did not induce immune-related adverse events. 
 
There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in 
IVF/ICSI patients undergoing COS. Following repeated daily subcutaneous administrations, 
REKOVELLE reaches steady-state within 6 to 7 days with a threefold higher concentration compared 
with the concentration after the first dose. Circulating levels of follitropin delta are inversely related to 
the body weight, which supports individualised dosing based on body weight. Follitropin delta leads to 
greater exposure than follitropin alfa. 
 
Absorption 
After daily subcutaneous administration of REKOVELLE, the time to maximum serum concentration 
is 10 hours. The absolute bioavailability is about 64%. 
 
Distribution 
The apparent volume of distribution is about 25 L after subcutaneous administration and the volume of 
distribution at steady state is 9 L after intravenous administration. Within the therapeutic dose range, 
exposure to follitropin delta increases proportionally with the dose.  
 
Elimination 
Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the 
clearance after intravenous is 0.3 L/h. The terminal elimination half-life after single subcutaneous 
administration is 40 hours and after multiple subcutaneous administration is 28 hours. The apparent 
clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to 
high exposure. Follitropin delta is expected to be eliminated similarly to other follitropins, i.e. mainly 
by the kidneys. The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity and local tolerance. The overdose of follitropin delta resulted in 
pharmacological or exaggerated pharmacological actions. Follitropin delta had a negative effect on 
fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day 
which is above the recommended maximal dose in humans. The relevance of these findings for the 
clinical use of REKOVELLE is limited. 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Phenol 
Polysorbate 20 
L-methionine 
Sodium sulphate decahydrate 
Disodium phosphate dodecahydrate 
Phosphoric acid, concentrated (for pH-adjustment) 
Sodium hydroxide (for pH-adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
In use: 28 days when stored at or below 25 °C. Keep the cartridge in the REKOVELLE injection pen. 
  
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C – 8 °C).  
Do not freeze. 
Before first use, store in the original package in order to protect from light. 
 
REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at 
or below 25 °C for up to 3 months including the period after first use. It must be discarded afterwards. 
 
For storage conditions after first use of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container  
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 0.36 mL of solution. 
Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE 
injection pen. 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 1.08 mL of solution. 
Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE 
injection pen. 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 2.16 mL of solution. 
Pack size of 1 cartridge and 9 injection needles (stainless steel) to be used with the REKOVELLE 
injection pen. 
 
6.6 Special precautions for disposal and other handling 
 
The solution should not be administered if it contains particles or is not clear. 
 



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REKOVELLE is designed for use in conjunction with the REKOVELLE injection pen provided 
separately. The instructions for use of the pen must be followed. Discard used needles immediately 
after injection. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1150/001 
EU/1/16/1150/002 
EU/1/16/1150/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 December 2016 
 
 
10. DATE OF REVISION OF THE TEXT 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen 
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen 
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution. 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution. 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution. 
 
One mL of solution contains 33.3 micrograms of follitropin delta* 
*recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by 
recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Solution for injection in a pre-filled pen (injection). 
 
Clear and colourless solution with a pH of 6.0-7.0. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted 
reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm 
injection (ICSI) cycle. 
 
There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol (see 
section 5.1). 
 
4.2 Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of 
fertility problems. 
 
Posology 
The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian 
response which is associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate 
number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation 
syndrome (OHSS). REKOVELLE is dosed in micrograms (see section 5.1). The dosing regimen is 
specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins. 



13 

 
For the first treatment cycle, the individual daily dose will be determined on the basis of the woman’s 
serum anti-Müllerian hormone (AMH) concentration and her body weight. The dose should be based 
on a recent determination of AMH (i.e. within the last 12 months) measured by the following 
diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4). The individual 
daily dose is to be maintained throughout the stimulation period. For women with AMH <15 pmol/L 
the daily dose is 12 micrograms, irrespective of body weight. For women with AMH ≥15 pmol/L the 
daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1). 
The dose is to be rounded off to the nearest 0.33 micrograms to match the dosing scale on the injection 
pen. The maximum daily dose for the first treatment cycle is 12 micrograms. 
For calculation of the REKOVELLE dose, the body weight is to be measured without shoes and 
overcoat just prior to start of stimulation. 
 
Table 1 Dosing regimen  

AMH (pmol/L) <15 15-16 17 18 19-20 21-22 23-24 25-27 28-32 33-39 ≥40 

Fixed daily dose 
of REKOVELLE  

12  0.19  0.18 0.17 0.16 0.15 0.14 0.13 0.12 0.11 0.10 

mcg mcg/kg 

The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer. If 
the AMH concentration is in ng/mL, the concentration should be converted to pmol/L by multiplying 
with 7.14 (ng/mL x 7.14 = pmol/L) before use. 
mcg: micrograms 
 
Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and 
continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on 
average is by the ninth day of treatment (range 5 to 20 days). A single injection of 250 micrograms 
recombinant human chorionic gonadotropin (hCG) or 5,000 IU hCG is administered to induce final 
follicular maturation. In patients with excessive follicular development (of ≥25 follicles ≥12 mm), 
treatment with REKOVELLE should be stopped and triggering of final follicular maturation with hCG 
should not be performed. 
 
For subsequent treatment cycles, the daily dose of REKOVELLE should be maintained or modified 
according to the patient’s ovarian response in the previous cycle. If the patient had adequate ovarian 
response in the previous cycle without developing OHSS, the same daily dose should be used. In case 
of ovarian hypo-response in the previous cycle, the daily dose in the subsequent cycle should be 
increased by 25% or 50%, according to the extent of response observed. In case of ovarian hyper-
response in the previous cycle, the daily dose in the subsequent cycle should be decreased by 20% or 
33%, according to the extent of response observed. In patients who developed OHSS or were at risk of 
OHSS in a previous cycle, the daily dose for the subsequent cycle is 33% lower than the dose used in 
the cycle where OHSS or risk of OHSS occurred. The maximum daily dose is 24 micrograms. 
 
Patients with renal and hepatic impairment 
Safety, efficacy and pharmacokinetics of REKOVELLE in patients with renal or hepatic impairment 
have not been specifically studied in clinical trials. Although limited, data did not indicate a need for a 
different dosing regimen of REKOVELLE in this patient population (see section 4.4). 
 
Polycystic ovarian syndrome patients with anovulatory disorders 
Anovulatory patients with polycystic ovarian syndrome have not been studied. Ovulatory patients with 
polycystic ovaries have been included in clinical trials (see section 5.1). 
 
Elderly 
There is no relevant use of REKOVELLE in the elderly population.  
 
Paediatric population 
There is no relevant use of REKOVELLE in the paediatric population. 



14 

 
Method of administration 
REKOVELLE is intended for subcutaneous use, preferably in the abdominal wall. The first injection 
should be performed under direct medical supervision. Patients must be educated on how to use the 
REKOVELLE injection pen and to perform injections. Self-administration should only be performed 
by patients who are well motivated, adequately trained and have access to expert advice. 
 
For instructions on the administration with the pre-filled pen, see the ”Instructions for Use”. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• tumours of the hypothalamus or pituitary gland 
• ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome 
• gynaecological haemorrhages of unknown aetiology (see section 4.4) 
• ovarian, uterine or mammary carcinoma (see section 4.4) 
 
In the following situations, treatment outcome is unlikely to be favourable, and therefore 
REKOVELLE should not be administered: 
• primary ovarian failure 
• malformations of sexual organs incompatible with pregnancy 
• fibroid tumours of the uterus incompatible with pregnancy 
 
4.4 Special warnings and precautions for use 
 
REKOVELLE contains a potent gonadotropic substance capable of causing mild to severe adverse 
reactions, and should only be used by physicians who are thoroughly familiar with infertility problems 
and their management. 
 
Gonadotropin therapy requires time commitment by physicians and supportive healthcare 
professionals, as well as the availability of appropriate monitoring facilities. Safe and effective use of 
REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with 
measurement of serum estradiol levels, on a regular basis. The dose of REKOVELLE is individualised 
for each patient to obtain an ovarian response with favourable safety/efficacy profile. There may be a 
degree of interpatient variability in response to FSH administration, with poor response to FSH in 
some patients and exaggerated response in others.  
 
Before starting treatment, the couple’s infertility should be assessed as appropriate and putative 
contraindications for pregnancy evaluated. In particular, patients should be evaluated for 
hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given. 
 
Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche for 
REKOVELLE dose determination is not recommended, as there currently is no standardisation of 
available AMH assays. 
 
Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be 
at risk of developing OHSS. Adherence to the REKOVELLE dose and regimen of administration and 
careful monitoring of therapy will minimise the incidence of such events. 
 
Ovarian Hyperstimulation Syndrome (OHSS) 
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is 
more commonly seen in patients with polycystic ovarian syndrome and usually regresses without 
treatment. In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest 
itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex 
steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the 
peritoneal, pleural and, rarely, in the pericardial cavities. 
 



15 

It is important to stress the value of careful and frequent monitoring of follicular development in order 
to reduce the risk of OHSS. The following symptoms may be observed in severe cases of OHSS: 
abdominal pain, discomfort and distension, severe ovarian enlargement, weight gain, dyspnoea, 
oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation 
may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, 
pleural effusions, hydrothorax, or acute pulmonary distress. Very rarely, severe OHSS may be 
complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic 
stroke or myocardial infarction. 
 
Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is 
administered to trigger final follicular maturation. Furthermore, the syndrome may be more severe and 
more protracted if pregnancy occurs. Therefore, in cases of ovarian hyperstimulation it is prudent to 
withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for 
at least 4 days. OHSS may progress rapidly (within 24 hours to several days) to become a serious 
medical event. It most often occurs after hormonal treatment has been discontinued. Also, as a 
consequence of the hormonal changes during pregnancy, late development of OHSS can occur. 
Because of the risk of developing OHSS patients should be followed for at least two weeks after 
triggering of final follicular maturation.  
 
Thromboembolic events 
Women with recent or ongoing thromboembolic disease or women with generally recognised risk 
factors for thromboembolic events, such as personal or family history, severe obesity (body mass 
index >30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic 
events, during or following treatment with gonadotropins. Treatment with gonadotropins may further 
increase the risk for aggravation or occurrence of such events. In these women, the benefits of 
gonadotropin administration need to be weighed against the risks. It should be noted however that 
pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events. 
 
Ovarian torsion 
Occurrence of ovarian torsion has been reported for ART cycles. It may be associated with other risk 
factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, 
previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood 
supply can be limited by early diagnosis and immediate detorsion. 
 
Multiple pregnancy 
Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes. In patients 
undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of 
embryos replaced, their quality and the patient age, although twin pregnancy can in rare occasions 
develop from single embryo transfers. The patients should be advised of the potential risk of multiple 
births before starting treatment. 
 
Pregnancy loss 
The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing controlled 
ovarian stimulation for ART than following natural conception. 
 
Ectopic pregnancy 
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is 
obtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancy 
after ART has been reported to be higher than in the general population. 
 
Reproductive system neoplasms 
There have been reports of ovarian and other reproductive system neoplasms, both benign and 
malignant, in women who have undergone multiple treatment regimens for infertility treatment. It is 
not established whether or not treatment with gonadotropins increases the risk of these tumours in 
infertile women. 
 



16 

Congenital malformation 
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous 
conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, 
sperm characteristics) and multiple pregnancy. 
 
Other medical conditions 
Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment 
with REKOVELLE. 
 
Renal and hepatic impairment 
REKOVELLE has not been studied in patients with moderate/severe renal or hepatic impairment.  
 
Sodium content 
REKOVELLE contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed with REKOVELLE. Clinically significant interactions 
with other medicinal products have neither been reported during REKOVELLE therapy, nor are 
expected.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
REKOVELLE is not indicated during pregnancy. No teratogenic risk has been reported, following 
controlled ovarian stimulation, in clinical use with gonadotropins. There are no data from the 
inadvertent exposure to REKOVELLE in pregnant women. Studies in animals have shown 
reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans 
(section 5.3).  
 
Breast-feeding 
REKOVELLE is not indicated during breastfeeding. 
 
Fertility 
REKOVELLE is indicated for use in infertility (see section 4.1). 
 
4.7 Effects on ability to drive and use machines 
 
REKOVELLE has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
The most frequently reported adverse reactions during treatment with REKOVELLE are headache, 
pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue. The frequency of these 
adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical 
trials.  
 
Tabulated list of adverse reactions 
The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the 
pivotal clinical trials according to MedDRA system organ class and frequency as follows: common 
(≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse 
reactions are presented in order of decreasing seriousness. 
 



17 

Table 2 Adverse reactions in pivotal clinical trials 

System Organ Class Common  (≥1/100 to <1/10) 
Uncommon  
(≥1/1,000 to <1/100) 

Psychiatric disorders  Mood swings 
 

Nervous system disorders Headache Somnolence  
Dizziness 
 

Gastrointestinal disorders Nausea Diarrhoea 
Vomiting 
Constipation 
Abdominal discomfort 
 

Reproductive system and breast 
disorders 

OHSS 
Pelvic pain 
Adnexa uteri pain 
Pelvic discomfort 

Vaginal haemorrhage 
Breast pain 
Breast tenderness 
 

General disorders and 
administration site conditions 

Fatigue  

 
Description of selected adverse reactions 
OHSS is an intrinsic risk of the ovarian stimulation. Known gastrointestinal symptoms associated with 
OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea. Ovarian 
torsion and thromboembolic events are known to be rare complications of ovarian stimulation 
treatment (see section 4.4).  
 
Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin 
therapy (see section 5.1). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see 
section 4.4). 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, 
ATC code: G03GA10 
 
Mechanism of action 
The most important effect resulting from parenteral administration of FSH is the development of 
multiple mature follicles. 
 
Follitropin delta is a recombinant human FSH. The amino acid sequences of the two FSH subunits in 
follitropin delta are identical to the endogenous human FSH sequences. Because follitropin delta is 
produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and 
follitropin beta. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


18 

Pharmacodynamic effects 
Following daily administration of equal IU doses of REKOVELLE and follitropin alfa as determined 
in the rat in vivo bioassay (Steelman-Pohley assay), higher ovarian response (i.e. estradiol, inhibin B 
and follicular volume) was observed in patients after administration of REKOVELLE compared to 
follitropin alfa. As the rat bioassay might not fully reflect the potency of the FSH in REKOVELLE in 
humans, REKOVELLE is dosed in micrograms and not in IU.  
 
The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH 
concentration. Conversely, increasing body weight leads to a decrease in the number of oocytes 
retrieved (only clinically relevant for REKOVELLE doses below 12 micrograms). The resulting 
REKOVELLE dosing regimen is in section 4.2. 
 
Clinical efficacy and safety 
The ESTHER-1 trial was a randomised, assessor-blinded, controlled trial in 1,326 IVF/ICSI patients. 
The trial compared the individualised dosing regimen of REKOVELLE where the daily dose is 
established for each patient and fixed throughout stimulation with no adjustments (see section 4.2) to 
follitropin alfa filled-by-mass at a starting dose of 11 micrograms (150 IU) for the first five days 
followed by dose adjustments from day 6 of stimulation based on follicular development in a GnRH 
antagonist protocol. The patients were up to 40 years of age and had regular menstrual cycles 
presumed to be ovulatory. Single blastocyst transfer on day 5 was compulsory with the exception of 
patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts 
were available. The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation 
rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and 
number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts 
transferred, respectively. 
 
The trial demonstrated that REKOVELLE was at least as effective as follitropin alfa in terms of 
ongoing pregnancy rate and ongoing implantation rate, as shown in Table 3.  
  
Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial  
 REKOVELLE in an 

individualised dosing 
regimen  
(N=665) 

Follitropin alfa  
 
  
(N=661) 

Difference [95% CI] 

Ongoing pregnancy rate  30.7% 31.6% -0.9% [-5.9%; 4.1%] 
Ongoing implantation rate  35.2% 35.8% -0.6% [-6.1%; 4.8%] 
Population: all randomised and exposed  
 
The impact of the AMH-based dosing regimen of REKOVELLE was also assessed in secondary 
endpoints, such as ovarian response and OHSS risk management. 
 
In the overall trial population, the mean number of oocytes retrieved was 10.0 ± 5.6 with 
REKOVELLE (N=636) in the individualised dosing regimen and 10.4 ± 6.5 with follitropin alfa 
(N=643) at a starting dose of 150 IU followed by dose adjustments.  
 
Among patients with AMH ≥15 pmol/L, the ovarian response with REKOVELLE (N=355) and 
follitropin alfa (N=353), respectively, was as follows: mean number of oocytes retrieved 11.6 ± 5.9 
and 13.3 ± 6.9, and proportion of patients with ≥20 oocytes 10.1% (36/355) and 15.6% (55/353). 
 
In ovulatory patients with polycystic ovaries, the incidence of early moderate/severe OHSS and/or 
preventive interventions for early OHSS was 7.7% with REKOVELLE and 26.7% with follitropin 
alfa.  
 



19 

Safety – immunogenicity 
Anti-FSH antibodies were measured pre-dosing and post-dosing in patients undergoing up to three 
repeated treatment cycles with REKOVELLE (665 patients in cycle 1 in the ESTHER-1 trial as well 
as 252 patients in cycle 2 and 95 patients in cycle 3 in the ESTHER-2 trial). The incidence of anti-FSH 
antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in 
cycle 3. These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure 
to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies 
after treatment with follitropin alfa. In all patients with anti-FSH antibodies, titres were undetectable 
or very low and without neutralising capacity. Repeated treatment with REKOVELLE of patients with 
pre-existing or treatment-induced anti-FSH antibodies did not increase the antibody titre, was not 
associated with decreased ovarian response, and did not induce immune-related adverse events. 
 
There is no clinical trial experience with REKOVELLE in the long GnRH agonist protocol. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic profile of follitropin delta has been investigated in healthy female subjects and in 
IVF/ICSI patients undergoing COS. Following repeated daily subcutaneous administrations, 
REKOVELLE reaches steady-state within 6 to 7 days with a threefold higher concentration compared 
with the concentration after the first dose. Circulating levels of follitropin delta are inversely related to 
the body weight, which supports individualised dosing based on body weight. Follitropin delta leads to 
greater exposure than follitropin alfa. 
 
Absorption 
After daily subcutaneous administration of REKOVELLE, the time to maximum serum concentration 
is 10 hours. The absolute bioavailability is about 64%. 
 
Distribution 
The apparent volume of distribution is about 25 L after subcutaneous administration and the volume of 
distribution at steady state is 9 L after intravenous administration. Within the therapeutic dose range, 
exposure to follitropin delta increases proportionally with the dose.  
 
Elimination 
Following subcutaneous administration, the apparent clearance of follitropin delta is 0.6 L/h and the 
clearance after intravenous is 0.3 L/h. The terminal elimination half-life after single subcutaneous 
administration is 40 hours and after multiple subcutaneous administration is 28 hours. The apparent 
clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to 
high exposure. Follitropin delta is expected to be eliminated similarly to other follitropins, i.e. mainly 
by the kidneys. The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity and local tolerance. The overdose of follitropin delta resulted in 
pharmacological or exaggerated pharmacological actions. Follitropin delta had a negative effect on 
fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day 
which is above the recommended maximal dose in humans. The relevance of these findings for the 
clinical use of REKOVELLE is limited. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Phenol 
Polysorbate 20 
L-methionine 



20 

Sodium sulphate decahydrate 
Disodium phosphate dodecahydrate 
Phosphoric acid, concentrated (for pH-adjustment) 
Sodium hydroxide (for pH-adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
In use: 28 days when stored at or below 25 °C. 
  
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C – 8 °C).  
Do not freeze. 
Before first use, store in the original package in order to protect from light. 
 
REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at 
or below 25 °C for up to 3 months including the period after first use. It must be discarded afterwards. 
 
For storage conditions after first use of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container  
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 0.36 mL of solution. 
Pack size of 1 pre-filled pen and 3 injection needles (stainless steel). 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 1.08 mL of solution. 
Pack size of 1 pre-filled pen and 6 injection needles (stainless steel). 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap 
(aluminium) with an inlay (rubber). Each cartridge contains 2.16 mL of solution. 
Pack size of 1 pre-filled pen and 9 injection needles (stainless steel). 
 
6.6 Special precautions for disposal and other handling 
 
The solution should not be administered if it contains particles or is not clear. 
 
The instructions for use of the pen must be followed. Discard used needles immediately after injection. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 



21 

7. MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1150/004 
EU/1/16/1150/005 
EU/1/16/1150/006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 December 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



23 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Bio-Technology General (Israel) Ltd. 
Be'er Tuvia Industrial Zone 
POB 571 
Kiryat Malachi 8310402 
Israel 
 
Name and address of the manufacturer responsible for batch release 
 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
Or 
 
Ferring Controlled Therapeutics Limited 
1 Redwood Place 
Peel Park Campus 
East Kilbride 
Glasgow G74 5PB 
United Kingdom 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2) 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 



24 

An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



27 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each multidose cartridge contains 12 micrograms follitropin delta in 0.36 mL 
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 multidose cartridge with 3 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For use only with the REKOVELLE injection pen. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



28 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/001  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 12 micrograms/0.36 mL 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



29 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
CARTRIDGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 12 micrograms/0.36 mL injection 
follitropin delta 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
12 mcg/0.36 mL 
 
 
6. OTHER 
 
 



30 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 36 micrograms/1.08 mL solution for injection 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each multidose cartridge contains 36 micrograms follitropin delta in 1.08 mL  
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 multidose cartridge with 6 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For use only with the REKOVELLE injection pen. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



31 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/002  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 36 micrograms/1.08 mL  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



32 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
CARTRIDGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 36 micrograms/1.08 mL injection 
follitropin delta 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
36 mcg/1.08 mL 
 
 
6. OTHER 
 
 
 
 
 



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 72 micrograms/2.16 mL solution for injection 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each multidose cartridge contains 72 micrograms follitropin delta in 2.16 mL  
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 multidose cartridge with 9 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For use only with the REKOVELLE injection pen. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



34 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/003  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 72 micrograms/2.16 mL  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



35 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
CARTRIDGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 72 micrograms/2.16 mL injection 
follitropin delta 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
72 mcg/2.16 mL 
 
 
6. OTHER 
 
 



36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled multidose pen delivers 12 micrograms follitropin delta in 0.36 mL 
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in a pre-filled pen 
1 multidose pre-filled pen with 3 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



37 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/004  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 12 micrograms/0.36 mL 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



38 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 12 micrograms/0.36 mL injection 
follitropin delta 
Subcutanous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
12 mcg/0.36 mL 
 
 
6. OTHER 
 
 
 



39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled multidose pen delivers 36 micrograms follitropin delta in 1.08 mL  
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in a pre-filled pen 
1 multidose pre-filled pen with 6 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



40 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/005  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 36 micrograms/1.08 mL  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



41 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 36 micrograms/1.08 mL injection 
follitropin delta 
Subcutanous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
36 mcg/1.08 mL 
 
 
6. OTHER 
 
 
 



42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen 
follitropin delta  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled multidose pen delivers 72 micrograms follitropin delta in 2.16 mL  
One mL of solution contains 33.3 micrograms of follitropin delta 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, disodium phosphate 
dodecahydrate, concentrated phosphoric acid, sodium hydroxide, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in a pre-filled pen 
1 multidose pre-filled pen with 9 pen injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



43 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Store in the original package in order to protect from light. 
The medicine may be stored at or below 25 °C for up to 3 months including the period after first use. It 
must be discarded afterwards.  
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1150/006  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
REKOVELLE 72 micrograms/2.16 mL  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



44 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
REKOVELLE 72 micrograms/2.16 mL injection 
follitropin delta 
Subcutanous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
After first use: Use within 28 days. Store at or below 25 °C. 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
72 mcg/2.16 mL 
 
 
6. OTHER 
 
 



45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



46 

Package leaflet: Information for the user 
 

REKOVELLE 12 micrograms/0.36 mL solution for injection 
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 



47 

 
Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 



48 

 
Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect your ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
 
REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the 
injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not 
use the cartridge if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The cartridge may be used for several injections. 
 



49 

If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 
If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


50 

5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the cartridge label and carton after 
EXP. The expiry date refers to the last day of that month. 
 
Store in refrigerator (2 °C - 8 °C). Do not freeze. 
Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE 
injection pen. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
 
- The active substance is follitropin delta. 

Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of 
solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each 
millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of 
1 cartridge and 3 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  



51 

 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60 
information.medicale@ferring.com  

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 



52 

Italia  
Ferring S.p.A.  
Tel: +39 02 640 00 11  

Suomi/Finland  
Ferring Lääkkeet Oy  
Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com 

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


53 

Package leaflet: Information for the user 
 

REKOVELLE 36 micrograms/1.08 mL solution for injection  
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 



54 

 
Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 



55 

 
Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect your ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
 
REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the 
injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not 
use the cartridge if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The cartridge may be used for several injections. 
 



56 

If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 
If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


57 

5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the cartridge label and carton after 
EXP. The expiry date refers to the last day of that month. 
 
Store in refrigerator (2 °C - 8 °C). Do not freeze. 
Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE 
injection pen. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
 
- The active substance is follitropin delta. 

Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of 
solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each 
millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of 
1 cartridge and 6 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  



58 

 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60  
information.medicale@ferring.com 

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 

mailto:cz1-info@ferring.com


59 

Italia  
Ferring S.p.A.  
Tel: +39 02 640 00 11  

Suomi/Finland  
Ferring Lääkkeet Oy  
Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com  

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


60 

Package leaflet: Information for the user 
 

REKOVELLE 72 micrograms/2.16 mL solution for injection 
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 



61 

 
Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 



62 

 
Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect your ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
 
REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the 
injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not 
use the cartridge if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The cartridge may be used for several injections. 
 



63 

If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 
If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


64 

5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the cartridge label and carton after 
EXP. The expiry date refers to the last day of that month. 
 
Store in refrigerator (2 °C - 8 °C). Do not freeze. 
Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE 
injection pen. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
  
- The active substance is follitropin delta. 

Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of 
solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each 
millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of 
1 cartridge and 9 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  



65 

 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60  
information.medicale@ferring.com 

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 

mailto:cz1-info@ferring.com


66 

Italia  
Ferring S.p.A.  
Tel: +39 02 640 00 11  

Suomi/Finland  
Ferring Lääkkeet Oy  
Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com  

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


67 

Package leaflet: Information for the user 
 

REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen  
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 



68 

 
Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 



69 

 
Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect your ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
The instructions for using the pre-filled pen must be followed carefully. Do not use the pre-filled pen 
if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The pre-filled pen may be used for several injections. 
 
If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 



70 

If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton 
after EXP. The expiry date refers to the last day of that month. 
Store in refrigerator (2 °C - 8 °C). Do not freeze. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


71 

Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
 
- The active substance is follitropin delta. 

Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 
0.36 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin 
delta in each millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is 
available in packs of 1 pre-filled pen and 3 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
Ferring Controlled Therapeutics Limited 
1 Redwood Place 
Peel Park Campus 
East Kilbride 
Glasgow G74 5PB 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  
 



72 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60 
information.medicale@ferring.com  

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 



73 

Italia  
Ferring S.p.A.  
Tel: +39 02 640 00 11  

Suomi/Finland  
Ferring Lääkkeet Oy  
Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com 

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


74 

Instructions For Use  
 

REKOVELLE pre-filled pen  
follitropin delta 

 
Your healthcare provider should show you how to prepare and inject REKOVELLE the right way 
before you inject it for the first time.  
Do not try to inject yourself until you have been shown the right way to give your injections by your 
healthcare provider. 
Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a 
new pen. There may be new information. Follow the instructions carefully even if you have used a 
similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of 
medicine.  
Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to 
give your REKOVELLE injection.   
 
The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 
1 dose of REKOVELLE. The pen is available in 3 different strengths: 
• 12 micrograms/0.36 mL 
• 36 micrograms/1.08 mL 
• 72 micrograms/2.16 mL 
 
 
REKOVELLE pre-filled pen and its parts 
 

 
 
 
Instructions for use – REKOVELLE (follitropin delta) pre-filled pen 
 
Important information 
• The REKOVELLE pre-filled pen and the needles are for use by only one person and should not 

be shared with others.  
• Use the pen only for the medical condition it is prescribed for and as directed by your healthcare 

provider.  
• If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this 

pen without help. Get help from a person with good eyesight who is trained to use the pen.  
• Call your healthcare provider or local representative of the marketing authorisation holder 

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE 
injection if you have questions.  

  
Information about your REKOVELLE pre-filled pen 
The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in 
marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 211.  
• The dose scale of the pen is numbered from 0 to 20 micrograms.  
• Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.  



75 

• When turning the dial to your dose, you will hear a click sound and feel resistance on the dial 
for each increment to help you dial the correct dose. 

  
Cleaning 
• If needed, the outside of your pen may be cleaned with a cloth moistened with water.  
• Do not put the pen in water or any other liquid. 
 
Storage  
• Always store the pen with the pen cap on and without a needle attached. 
• Do not use the pen after the month of expiration (EXP) printed on the pen label.  
• Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in 

a car or freezer. 
• Store the pen out of the reach of children and anyone who has not been trained to use the pen. 
  

Before use: 
• Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze. 
• If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months 

including the in-use period. Throw away (dispose of) the pen if it has not been used after 
3 months. 

 
After first use (in-use period): 
• The pen may be stored for up to 28 days at 2°C to 25°C.  

 
Supplies you will need to give your REKOVELLE injection 
 

 
 
Before use – (Step 1) 
Step 1:  
• Wash your hands. 
• Check the pen to see that it is not damaged. Do not use the pen if it is damaged. 
• Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not 

use a pen with particles or unclear medicine in the cartridge.  
• Make sure you have the correct pen with correct strength. 
• Check the expiration on the pen label. 
 

 
 



76 

Attaching needle – (Step 2 to 6) 
 
Important: 
• Always use a new needle for each injection. 
• Only use the single-use click-on needles supplied with the pen. 
 
Step 2: 
• Pull off the pen cap. 

 

 
 
Step 3: 
• Pull off the protective foil from the needle. 

 

 
 
Step 4: 
• Click on the needle. 
• You will hear or feel a click when the needle is safely on. 
• You may also screw on the needle. When you feel a light resistance it is safely on. 

 

 
 
Step 5: 
• Pull off the outer needle cap. 
• Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle 

after injecting the medicine. 
 

 
 
Step 6: 
• Pull off the inner needle cap and throw it away. 

 

 
 



77 

Priming – (Step 7 to 9) 
 
• Before using the pen for the first time, you need to remove air bubbles from the cartridge 

(Priming) to receive the correct dose of medicine.  
• Only prime your pen the first time you use it.  
• Perform Step 7 to 9 even if you do not see air bubbles. 
• If the pen has already been used proceed directly to Step 10. 
 
Step 7: 
• Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.  
• If you dial the incorrect priming dose, the priming dose can be corrected either up or down 

without loss of medicine by turning the dose knob in either direction until the symbol of a 
droplet lines up with the dose indicator. 
 

 
 
Step 8: 
• Hold the pen with the needle pointing upwards.  

• Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the 
top of the cartridge. 
 

 
 
Step 9: 
• With the needle still pointing upwards (away from the face) press in the injection button all the 

way in until you see the number ‘0’ lined up with the dose indicator.  
• Check that a droplet of liquid appears at the tip of the needle.  
• If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears. 
• If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle  

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).  
 

 



78 

Dialing the dose – (Step 10) 
 
See “Examples of how to dial a dose” at Page 20 to 211.  
 
Step 10: 
• Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the 

dose display window. 
• The dose can be corrected either up or down without loss of medicine by turning the dose knob 

in either direction until the correct dose lines up with the dose indicator.  
• Do not press the injection button when dialing the dose to avoid loss of medicine. 
 

 
 
Split-dosing: 
• You may need more than one pen to complete your prescribed dose. 
• If you are not able to dial your complete dose, this means there is not enough medicine left in 

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen 
and use a new pen for your injection.  

 
See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and 
record your split dose. 
 
 
Injecting the dose – (Step 11 to 12) 
 
Important:  
• Do not use the pen if the medicine contains particles or if the medicine is not clear.  
• Read Step 11 and 12 at Page 14 to 151 before giving your injection. 
• This medicine should be given by injection just under the skin (subcutaneously) in the  

stomach-area (abdomen).  
• Use a new injection site for each injection to lower the risk of skin reactions as redness and 

irritation. 
• Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have 

stretch marks. 
 
Step 11 and 12: 
• Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area 

again before you give your injection. 
• Hold the pen so the dose display window is visible during injection.  
• Pinch your skin and insert the needle straight into your skin as shown by your healthcare 

provider. Do not touch the injection button yet. 
• After the needle is inserted, place your thumb on the injection button.  
• Press the injection button all the way in and hold.  
• Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose 

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose. 
 

  



79 

 
• After pressing in the injection button for 5 seconds, release the injection button. Then slowly 

remove the needle from the injection site by pulling it straight out of the skin. 
• If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site. 
 
Note: 
• Do not tilt the pen during injection and removal from skin.  
• Tilting the pen can cause the needle to bend or break off.  
• If a broken needle remains stuck in the body or remains under the skin, get medical help right 

away. 
 
 
Disposal of Needle – (Step 13) 
 
Step 13: 
• Carefully replace the outer needle cap over the needle with a firm push (A). 
• Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).  
• Throw away (dispose of) the used needle carefully (D). 
• See “Disposal” at Page 181.    
 

 
 
Note: 
• Always remove the needle after every use. The needles are for single-use only. 
• Do not store the pen with the needle attached. 
 
 
Replace pen cap – (Step 14) 
 
Step 14: 
• Firmly replace the pen cap on the pen for protection between injections. 
 

 
 
Note: 
• The pen cap will not fit over a needle. 
• If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.  
• If you will use a new pen to give your full prescribed dose instead of giving a split-dose 

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a 
full dose. 

• Keep the pen cap on the pen when it is not in use. 
 
 



80 

Disposal 
 
Needles: 
Put your used needles in a puncture-resistant container, such as a sharps disposal container right away 
after use. Do not throw away (dispose of) your used sharps disposal container in your household trash. 
 
If you do not have a sharps disposal container, you may use a household container that is:  
• made of a heavy-duty plastic,  
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,  
• upright and stable during use,  
• leak-resistant, and  
• properly labeled to warn of hazardous waste inside the container.  
 
When your sharps disposal container is almost full, you will need to follow your community 
guidelines for the right way to dispose of your sharps disposal container. There may be state or local 
laws about how you should throw away used needles. 
 
REKOVELLE pre-filled pens: 
• Throw away (dispose of) your used pens in accordance with local waste regulations. 
 
 
Examples of how to dial a dose 
 
Examples of how to dial a dose using your REKOVELLE pre-filled pen  
The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses, 
and what the dose display window looks like for the prescribed doses.   
 
Examples of 
prescribed dose  
(in micrograms) 

Dose to dial on pen Dose display window for example of prescribed dose 

0.33 0 and 1 line  (Dial to 0 plus 1 click) 
 

0.66 (priming dose) 0 and 2 lines  (Dial to 0 plus 2 clicks) 

 

2.33 2 and 1 line  (Dial to 2 plus 1 click) 
 

11.00 11 (Dial to 11) 
 

12.33 12 and 1 line  (Dial to 12 plus 1 click) 
 

18.66 18 and 2 lines  (Dial to 18 plus 2 clicks) 
 

20.00 20 (Dial to 20) 

 



81 

Giving a split-dose of REKOVELLE 
 
If you are not able to dial the full prescribed dose in your pen, this means that there is not enough 
medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using 
your current pen and the remainder of the dose using a new pen (split-dose injection) or you may 
throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 
1 injection. If you decide to give a split-dose injection, follow these instructions and write down how 
much medicine to give using the split-dose diary on Page 231. 
 
• Column A shows an example of a prescribed dose. Write down your prescribed dose in column 

A. 
• Column B shows an example of the dose that is left in the pen (this is equal to what you are able 

to dial). 
• Write down the dose that is left in your pen in column B. Give the injection using the rest of the 

medicine that is left in your pen. 
• Prepare and prime a new pen (Step 1 to 9).  
• Calculate and write down the remaining dose to inject in column C by subtracting the number in 

column B from the number in column A. Use a calculator to check your math if needed. 
• See “Examples of how to dial a dose” at Page 20 to 211 if needed. 
• Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For 

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number 
in column C is 9.67, round your remaining dose to 9.66.  

• Call your healthcare provider if you have questions about how to calculate your split-dose. 
• Inject the remaining dose of medicine (the number in column C) using your new pen to 

complete your prescribed dose. 
 
Split-dose diary 
 

 
 
 



82 

Frequently Asked Questions (FAQ) 
 
1. Is the priming step necessary before each injection? 

• No. Priming must be performed only before giving the first injection with a new pen.  
 
2. How do I know that the injection is complete? 

• The injection button is firmly pushed in all the way until it stops. 
• The number ‘0’ is lined up with the dose indicator. 
• You have slowly counted to 5 while you are still holding the injection button in and the 

needle is still in your skin. 
 
3. Why do I have to count to 5 while holding the injection button? 

• Holding the injection button for 5 seconds allows for the full dose to be injected and 
absorbed under your skin. 

 
4. What if the dose knob cannot be turned to the required dose? 

• The cartridge in the pen may not have enough medicine left to deliver the prescribed 
dose. 

• The pen does not allow you to dial a larger dose than the dose that is left in the cartridge. 
• You can inject the medicine left in the pen and complete the prescribed dose with a new 

pen (split-dose) or use a new pen to give the full prescribed dose. 
 
 
Warnings 
 
• Do not use a pen if it has been dropped or hit against hard surfaces.  
• If the injection button is not easy to push in, do not use force. Change the needle. If the injection 

button still is not easy to push in after changing the needle, use a new pen.  
• Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or 

local representative of the marketing authorisation holder (please refer to patient information 
leaflet for contact details). 

 
 
Additional information 
 
Needles 
Needles are supplied with your pen. If you need additional needles contact your healthcare provider. 
Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider 
prescribes. 
 
Contact 
If you have any questions or problems related to the pen, contact your healthcare provider or local 
representative of the marketing authorisation holder (please refer to patient information leaflet for 
contact details). 
 
 
 
 
 
 
 
 
 
 
 
 

1. Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document. 



83 

Package leaflet: Information for the user 
 

REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen 
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 



84 

Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 
 



85 

Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect you’re ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
The instructions for using the pre-filled  pen must be followed carefully. Do not use the pre-filled pen 
if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The pre-filled pen may be used for several injections. 
 
If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 



86 

If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton 
after EXP. The expiry date refers to the last day of that month. 
 
Store in refrigerator (2 °C - 8 °C). Do not freeze. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


87 

Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
 
- The active substance is follitropin delta. 

Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 
1.08 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin 
delta in each millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is 
available in packs of 1 pre-filled pen and 6 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
Ferring Controlled Therapeutics Limited 
1 Redwood Place 
Peel Park Campus 
East Kilbride 
Glasgow G74 5PB 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  
 



88 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60  
information.medicale@ferring.com 

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 

Italia  
Ferring S.p.A.  

Suomi/Finland  
Ferring Lääkkeet Oy  

mailto:cz1-info@ferring.com


89 

Tel: +39 02 640 00 11  Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com  

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


90 

Instructions For Use  
 

REKOVELLE pre-filled pen  
follitropin delta 

 
Your healthcare provider should show you how to prepare and inject REKOVELLE the right way 
before you inject it for the first time.  
Do not try to inject yourself until you have been shown the right way to give your injections by your 
healthcare provider. 
Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a 
new pen. There may be new information. Follow the instructions carefully even if you have used a 
similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of 
medicine.  
Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to 
give your REKOVELLE injection.   
 
The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 
1 dose of REKOVELLE. The pen is available in 3 different strengths: 
• 12 micrograms/0.36 mL 
• 36 micrograms/1.08 mL 
• 72 micrograms/2.16 mL 
 
 
REKOVELLE pre-filled pen and its parts 
 

 
 
 
Instructions for use – REKOVELLE (follitropin delta) pre-filled pen 
 
Important information 
• The REKOVELLE pre-filled pen and the needles are for use by only one person and should not 

be shared with others.  
• Use the pen only for the medical condition it is prescribed for and as directed by your healthcare 

provider.  
• If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this 

pen without help. Get help from a person with good eyesight who is trained to use the pen.  
• Call your healthcare provider or local representative of the marketing authorisation holder 

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE 
injection if you have questions.  

  
Information about your REKOVELLE pre-filled pen 
The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in 
marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 211.  
• The dose scale of the pen is numbered from 0 to 20 micrograms.  
• Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.  



91 

• When turning the dial to your dose, you will hear a click sound and feel resistance on the dial 
for each increment to help you dial the correct dose. 

  
Cleaning 
• If needed, the outside of your pen may be cleaned with a cloth moistened with water.  
• Do not put the pen in water or any other liquid. 
 
Storage  
• Always store the pen with the pen cap on and without a needle attached. 
• Do not use the pen after the month of expiration (EXP) printed on the pen label.  
• Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in 

a car or freezer. 
• Store the pen out of the reach of children and anyone who has not been trained to use the pen. 
  

Before use: 
• Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze. 
• If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months 

including the in-use period. Throw away (dispose of) the pen if it has not been used after 
3 months. 

 
After first use (in-use period): 
• The pen may be stored for up to 28 days at 2°C to 25°C.  

 
Supplies you will need to give your REKOVELLE injection 
 

 
 
Before use – (Step 1) 
Step 1:  
• Wash your hands. 
• Check the pen to see that it is not damaged. Do not use the pen if it is damaged. 
• Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not 

use a pen with particles or unclear medicine in the cartridge.  
• Make sure you have the correct pen with correct strength. 
• Check the expiration on the pen label. 
 

 
 



92 

Attaching needle – (Step 2 to 6) 
 
Important: 
• Always use a new needle for each injection. 
• Only use the single-use click-on needles supplied with the pen. 
 
Step 2: 
• Pull off the pen cap. 

 

 
 
Step 3: 
• Pull off the protective foil from the needle. 

 

 
 
Step 4: 
• Click on the needle. 
• You will hear or feel a click when the needle is safely on. 
• You may also screw on the needle. When you feel a light resistance it is safely on. 

 

 
 
Step 5: 
• Pull off the outer needle cap. 
• Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle 

after injecting the medicine. 
 

 
 
Step 6: 
• Pull off the inner needle cap and throw it away. 

 

 
 



93 

Priming – (Step 7 to 9) 
 
• Before using the pen for the first time, you need to remove air bubbles from the cartridge 

(Priming) to receive the correct dose of medicine.  
• Only prime your pen the first time you use it.  
• Perform Step 7 to 9 even if you do not see air bubbles. 
• If the pen has already been used proceed directly to Step 10. 
 
Step 7: 
• Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.  
• If you dial the incorrect priming dose, the priming dose can be corrected either up or down 

without loss of medicine by turning the dose knob in either direction until the symbol of a 
droplet lines up with the dose indicator. 
 

 
 
Step 8: 
• Hold the pen with the needle pointing upwards.  

• Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the 
top of the cartridge. 
 

 
 
Step 9: 
• With the needle still pointing upwards (away from the face) press in the injection button all the 

way in until you see the number ‘0’ lined up with the dose indicator.  
• Check that a droplet of liquid appears at the tip of the needle.  
• If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears. 
• If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle  

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).  
 

 



94 

Dialing the dose – (Step 10) 
 
See “Examples of how to dial a dose” at Page 20 to 211.  
 
Step 10: 
• Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the 

dose display window. 
• The dose can be corrected either up or down without loss of medicine by turning the dose knob 

in either direction until the correct dose lines up with the dose indicator.  
• Do not press the injection button when dialing the dose to avoid loss of medicine. 
 

 
 
Split-dosing: 
• You may need more than one pen to complete your prescribed dose. 
• If you are not able to dial your complete dose, this means there is not enough medicine left in 

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen 
and use a new pen for your injection.  

 
See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and 
record your split dose. 
 
 
Injecting the dose – (Step 11 to 12) 
 
Important:  
• Do not use the pen if the medicine contains particles or if the medicine is not clear.  
• Read Step 11 and 12 at Page 14 to 151 before giving your injection. 
• This medicine should be given by injection just under the skin (subcutaneously) in the  

stomach-area (abdomen).  
• Use a new injection site for each injection to lower the risk of skin reactions as redness and 

irritation. 
• Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have 

stretch marks. 
 
Step 11 and 12: 
• Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area 

again before you give your injection. 
• Hold the pen so the dose display window is visible during injection.  
• Pinch your skin and insert the needle straight into your skin as shown by your healthcare 

provider. Do not touch the injection button yet. 
• After the needle is inserted, place your thumb on the injection button.  
• Press the injection button all the way in and hold.  
• Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose 

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose. 
 

  



95 

 
• After pressing in the injection button for 5 seconds, release the injection button. Then slowly 

remove the needle from the injection site by pulling it straight out of the skin. 
• If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site. 
 
Note: 
• Do not tilt the pen during injection and removal from skin.  
• Tilting the pen can cause the needle to bend or break off.  
• If a broken needle remains stuck in the body or remains under the skin, get medical help right 

away. 
 
 
Disposal of Needle – (Step 13) 
 
Step 13: 
• Carefully replace the outer needle cap over the needle with a firm push (A). 
• Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).  
• Throw away (dispose of) the used needle carefully (D). 
• See “Disposal” at Page 181.    
 

 
 
Note: 
• Always remove the needle after every use. The needles are for single-use only. 
• Do not store the pen with the needle attached. 
 
 
Replace pen cap – (Step 14) 
 
Step 14: 
• Firmly replace the pen cap on the pen for protection between injections. 
 

 
 
Note: 
• The pen cap will not fit over a needle. 
• If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.  
• If you will use a new pen to give your full prescribed dose instead of giving a split-dose 

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a 
full dose. 

• Keep the pen cap on the pen when it is not in use. 
 
 



96 

Disposal 
 
Needles: 
Put your used needles in a puncture-resistant container, such as a sharps disposal container right away 
after use. Do not throw away (dispose of) your used sharps disposal container in your household trash. 
 
If you do not have a sharps disposal container, you may use a household container that is:  
• made of a heavy-duty plastic,  
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,  
• upright and stable during use,  
• leak-resistant, and  
• properly labeled to warn of hazardous waste inside the container.  
 
When your sharps disposal container is almost full, you will need to follow your community 
guidelines for the right way to dispose of your sharps disposal container. There may be state or local 
laws about how you should throw away used needles. 
 
REKOVELLE pre-filled pens: 
• Throw away (dispose of) your used pens in accordance with local waste regulations. 
 
 
Examples of how to dial a dose 
 
Examples of how to dial a dose using your REKOVELLE pre-filled pen  
The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses, 
and what the dose display window looks like for the prescribed doses.   
 
Examples of 
prescribed dose  
(in micrograms) 

Dose to dial on pen Dose display window for example of prescribed dose 

0.33 0 and 1 line  (Dial to 0 plus 1 click) 
 

0.66 (priming dose) 0 and 2 lines  (Dial to 0 plus 2 clicks) 

 

2.33 2 and 1 line  (Dial to 2 plus 1 click) 
 

11.00 11 (Dial to 11) 
 

12.33 12 and 1 line  (Dial to 12 plus 1 click) 
 

18.66 18 and 2 lines  (Dial to 18 plus 2 clicks) 
 

20.00 20 (Dial to 20) 

 



97 

Giving a split-dose of REKOVELLE 
 
If you are not able to dial the full prescribed dose in your pen, this means that there is not enough 
medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using 
your current pen and the remainder of the dose using a new pen (split-dose injection) or you may 
throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 
1 injection. If you decide to give a split-dose injection, follow these instructions and write down how 
much medicine to give using the split-dose diary on Page 231. 
 
• Column A shows an example of a prescribed dose. Write down your prescribed dose in column 

A. 
• Column B shows an example of the dose that is left in the pen (this is equal to what you are able 

to dial). 
• Write down the dose that is left in your pen in column B. Give the injection using the rest of the 

medicine that is left in your pen. 
• Prepare and prime a new pen (Step 1 to 9).  
• Calculate and write down the remaining dose to inject in column C by subtracting the number in 

column B from the number in column A. Use a calculator to check your math if needed. 
• See “Examples of how to dial a dose” at Page 20 to 211 if needed. 
• Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For 

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number 
in column C is 9.67, round your remaining dose to 9.66.  

• Call your healthcare provider if you have questions about how to calculate your split-dose. 
• Inject the remaining dose of medicine (the number in column C) using your new pen to 

complete your prescribed dose. 
 
Split-dose diary 
 

 
 
 



98 

Frequently Asked Questions (FAQ) 
 
1. Is the priming step necessary before each injection? 

• No. Priming must be performed only before giving the first injection with a new pen.  
 
2. How do I know that the injection is complete? 

• The injection button is firmly pushed in all the way until it stops. 
• The number ‘0’ is lined up with the dose indicator. 
• You have slowly counted to 5 while you are still holding the injection button in and the 

needle is still in your skin. 
 
3. Why do I have to count to 5 while holding the injection button? 

• Holding the injection button for 5 seconds allows for the full dose to be injected and 
absorbed under your skin. 

 
4. What if the dose knob cannot be turned to the required dose? 

• The cartridge in the pen may not have enough medicine left to deliver the prescribed 
dose. 

• The pen does not allow you to dial a larger dose than the dose that is left in the cartridge. 
• You can inject the medicine left in the pen and complete the prescribed dose with a new 

pen (split-dose) or use a new pen to give the full prescribed dose. 
 
 
Warnings 
 
• Do not use a pen if it has been dropped or hit against hard surfaces.  
• If the injection button is not easy to push in, do not use force. Change the needle. If the injection 

button still is not easy to push in after changing the needle, use a new pen.  
• Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or 

local representative of the marketing authorisation holder (please refer to patient information 
leaflet for contact details). 

 
 
Additional information 
 
Needles 
Needles are supplied with your pen. If you need additional needles contact your healthcare provider. 
Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider 
prescribes. 
 
Contact 
If you have any questions or problems related to the pen, contact your healthcare provider or local 
representative of the marketing authorisation holder (please refer to patient information leaflet for 
contact details). 
 
 
 
 
 
 
 
 
 
 
 
 

1. Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document. 



99 

Package leaflet: Information for the user 
 

REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen 
follitropin delta 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What REKOVELLE is and what it is used for 
2. What you need to know before you use REKOVELLE 
3. How to use REKOVELLE 
4. Possible side effects 
5. How to store REKOVELLE 
6. Contents of the pack and other information 
 
 
1. What REKOVELLE is and what it is used for 
 
REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of 
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility. 
 
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted 
reproduction programmes such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection 
(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from 
which eggs are collected and fertilised in the laboratory. 
 
 
2. What you need to know before you use REKOVELLE 
 
Before starting treatment with this medicine, a doctor should check you and your partner for possible 
causes of your fertility problems. 
 
Do not use REKOVELLE if: 
 
• you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine 

(listed in section 6) 
• you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus 
• you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian 

disease) 
• you suffer from bleeding from the vagina without any known cause 
• you have had an early menopause 
• you have malformations of the sexual organs which make a normal pregnancy impossible 
• you have fibroids of the uterus which make a normal pregnancy impossible. 
 



100 

Warnings and precautions 
 
Ovarian hyperstimulation syndrome 
Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your 
follicles develop too much and become large cysts. 
Talk to your doctor if you: 
• have abdominal pain, discomfort or swelling 
• have nausea  
• are vomiting  
• get diarrhoea 
• gain weight  
• have difficulty in breathing 
Your doctor may ask you to stop using this medicine (see section 4). 
If the recommended dose and schedule of administration are followed, ovarian hyperstimulation 
syndrome is less likely. 
 
Blood clotting problems (thromboembolic events) 
Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility 
treatment can increase the risk of this happening, especially if you are overweight or you or someone 
in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor 
if you think this applies to you. 
 
Twisting of ovaries 
There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive 
technology treatment. Twisting of the ovary could cut off the blood flow to the ovary. 
 
Multiple pregnancy and birth defects 
When undergoing assisted reproductive technology treatment the possibility of having a multiple 
pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the 
quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you 
and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility 
treatment, which is thought to be due to characteristics of the parents (such as your age, and your 
partner’s sperm characteristics) and multiple pregnancy. 
 
Pregnancy loss 
When undergoing assisted reproductive technology treatment, you are more likely to have a 
miscarriage than if you conceive naturally. 
 
Pregnancy outside the uterus (ectopic pregnancy) 
When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy 
outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal 
disease, you have an increased risk of ectopic pregnancy. 
 
Ovarian and other reproductive system tumours 
There have been reports of ovarian and other reproductive system tumours in women who had 
undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of 
these tumours in infertile women. 
 
Other medical conditions 
Before starting to use this medicine, tell your doctor if:  
• you have been told by another doctor that pregnancy would be dangerous for you 
• you have kidney or liver disease 
 
Children and adolescents (under 18 years of age) 
 
This medicine is not indicated in children and adolescents. 
 



101 

Other medicines and REKOVELLE 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Pregnancy and breast-feeding 
 
Do not use this medicine if you are pregnant or breast-feeding. 
 
Driving and using machines 
 
This medicine does not affect your ability to drive and use machines. 
 
REKOVELLE contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
“sodium-free”. 
 
 
3. How to use REKOVELLE 
 
Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you. 
Check with your doctor if you are not sure. 
 
The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level 
of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with 
gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample 
(taken within the last 12 months) should be available before you start treatment. Your body weight 
will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms. 
 
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or 
decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and 
treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given 
a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 
250 micrograms or 5,000 IU for final development of the follicles. 
 
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop 
treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you 
either a higher or a lower daily dose of REKOVELLE than before. 
 
How are injections given 
The instructions for using the pre-filled  pen must be followed carefully. Do not use the pre-filled pen 
if the solution contains particles or if the solution does not look clear. 
 
The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your 
doctor will decide if you can give yourself further doses of this medicine at home, but only after 
receiving adequate training. 
 
This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen. 
The pre-filled pen may be used for several injections. 
 
If you use more REKOVELLE than you should 
 
The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome 
may possibly occur, which is described in section 4. 
 



102 

If you forget to use REKOVELLE 
 
Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you 
notice that you forgot a dose. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
 
Hormones used in the treatment of infertility such as this medicine may cause a high level of activity 
in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or 
swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have 
any of these symptoms you should contact a doctor immediately. 
 
The risk of having a side effect is described by the following categories: 
 
Common (may affect up to 1 in 10 people): 
 
• Headache 
• Nausea 
• Ovarian hyperstimulation syndrome (see above) 
• Pelvic pain and discomfort, including of ovarian origin 
• Tiredness (fatigue) 

 
Uncommon (may affect up to 1 in 100 people): 
 
• Mood swings 
• Sleepiness/drowsiness 
• Dizziness 
• Diarrhoea 
• Vomiting 
• Constipation 
• Discomfort of the abdomen 
• Vaginal bleeding 
• Breast complaints (include breast pain, breast tenderness) 
 
Reporting of side effects 
 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store REKOVELLE 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton 
after EXP. The expiry date refers to the last day of that month. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


103 

Store in refrigerator (2 °C - 8 °C). Do not freeze. 
Before first use, store in the original package in order to protect from light. 
REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use. 
It must not be refrigerated again and must be discarded if it has not been used after 3 months. 
 
After first use: 28 days when stored at or below 25 °C. 
 
At the end of the treatment any unused solution must be discarded. 
 
Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of 
medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What REKOVELLE contains 
  
- The active substance is follitropin delta. 

Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 
2.16 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin 
delta in each millilitre of solution. 

- The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate, 
disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water 
for injections. 

 
What REKOVELLE looks like and contents of the pack 
 
REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is 
available in packs of 1 pre-filled pen and 9 pen injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
Ferring Controlled Therapeutics Limited 
1 Redwood Place 
Peel Park Campus 
East Kilbride 
Glasgow G74 5PB 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V.  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  

Lietuva 
UAB PharmaSwiss 
Tel: +370 5 2790762  
lithuania.info@pharmaswiss.com  
 



104 

България 
Аквaxим АД  
Тел: +359 2 807 5022  
aquachim@aquachim.bg  

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika  
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333  
cz1-info@ferring.com  

Magyarország  
Ferring Magyarország Gyógyszerkereskedelmi Kft.  
Tel: +36 1 236 3800  
ferring@ferring.hu  
 

Danmark  
Ferring Lægemidler A/S  
Tlf: +45 88 16 88 17  

Malta  
E.J. Busuttil Ltd.  
Tel: +356 21447184  
info@ejbusuttil.com  
 

Deutschland  
Ferring Arzneimittel GmbH  
Tel: +49 431 5852 0  
info-service@ferring.de  

Nederland  
Ferring B.V.  
Tel: +31 235680300  
infoNL@ferring.com  
 

Eesti  
PharmaSwiss Eesti OÜ  
Tel: +372 682 7400  
estonia.info@pharmaswiss.com  

Norge  
Ferring Legemidler AS  
Tlf: +47 22 02 08 80  
mail@oslo.ferring.com  
 

Ελλάδα  
Ferring Ελλάς ΜΕΠΕ  
Τηλ: +30 210 68 43 449  

Österreich  
Ferring Arzneimittel Ges.m.b.H  
Tel: +43 1 60 8080 
office@ferring.at  
 

España  
Ferring S.A.U.  
Tel: +34 91 387 70 00  
Registros@ferring.com  

Polska  
Ferring Pharmaceuticals Poland Sp. z o.o.  
Tel: +48 22 246 06 80  
ferring@ferring.pl  
 

France  
Ferring S.A.S.  
Tél: +33 1 49 08 67 60  
information.medicale@ferring.com 

Portugal  
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90  
geral@ferring.com  
 

Hrvatska  
Clinres farmacija d.o.o.  
Tel: +385 1 2396 900  

România  
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270  
 

Ireland  
Ferring Ireland Ltd.  
Tel: +353 1 4637355  
enquiries.ireland@ferring.com  

Slovenija  
SALUS, Veletrgovina, d.o.o.  
Tel: +386 1 5899 179  
regulatory@salus.si  
 

Ísland  
Vistor hf.  
Sími: +354 535 70 00  

Slovenská republika  
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010  
SK0-Recepcia@ferring.com  
 

Italia  
Ferring S.p.A.  

Suomi/Finland  
Ferring Lääkkeet Oy  

mailto:cz1-info@ferring.com


105 

Tel: +39 02 640 00 11  Puh/Tel: +358 207 401 440  
info@ferring.fi  
 

Κύπρος  
A.Potamitis Medicare Ltd  
Τηλ: +357 22583333  
a.potamitismedicare@cytanet.com.cy  

Sverige  
Ferring Läkemedel AB  
Tel: +46 40 691 69 00  
info@ferring.se  
 

Latvija  
SIA PharmaSwiss Latvia  
Tālr: +371 6 750 2185  
latvia.info@pharmaswiss.com  

United Kingdom  
Ferring Pharmaceuticals Ltd.  
Tel: +44 844 931 0050  
contact2@ferring.com  

 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/


106 

Instructions For Use  
 

REKOVELLE pre-filled pen  
follitropin delta 

 
Your healthcare provider should show you how to prepare and inject REKOVELLE the right way 
before you inject it for the first time.  
Do not try to inject yourself until you have been shown the right way to give your injections by your 
healthcare provider. 
Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a 
new pen. There may be new information. Follow the instructions carefully even if you have used a 
similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of 
medicine.  
Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to 
give your REKOVELLE injection.   
 
The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than 
1 dose of REKOVELLE. The pen is available in 3 different strengths: 
• 12 micrograms/0.36 mL 
• 36 micrograms/1.08 mL 
• 72 micrograms/2.16 mL 
 
 
REKOVELLE pre-filled pen and its parts 
 

 
 
 
Instructions for use – REKOVELLE (follitropin delta) pre-filled pen 
 
Important information 
• The REKOVELLE pre-filled pen and the needles are for use by only one person and should not 

be shared with others.  
• Use the pen only for the medical condition it is prescribed for and as directed by your healthcare 

provider.  
• If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this 

pen without help. Get help from a person with good eyesight who is trained to use the pen.  
• Call your healthcare provider or local representative of the marketing authorisation holder 

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE 
injection if you have questions.  

  
Information about your REKOVELLE pre-filled pen 
The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in 
marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 211.  
• The dose scale of the pen is numbered from 0 to 20 micrograms.  
• Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.  



107 

• When turning the dial to your dose, you will hear a click sound and feel resistance on the dial 
for each increment to help you dial the correct dose. 

  
Cleaning 
• If needed, the outside of your pen may be cleaned with a cloth moistened with water.  
• Do not put the pen in water or any other liquid. 
 
Storage  
• Always store the pen with the pen cap on and without a needle attached. 
• Do not use the pen after the month of expiration (EXP) printed on the pen label.  
• Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in 

a car or freezer. 
• Store the pen out of the reach of children and anyone who has not been trained to use the pen. 
  

Before use: 
• Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze. 
• If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months 

including the in-use period. Throw away (dispose of) the pen if it has not been used after 
3 months. 

 
After first use (in-use period): 
• The pen may be stored for up to 28 days at 2°C to 25°C.  

 
Supplies you will need to give your REKOVELLE injection 
 

 
 
Before use – (Step 1) 
Step 1:  
• Wash your hands. 
• Check the pen to see that it is not damaged. Do not use the pen if it is damaged. 
• Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not 

use a pen with particles or unclear medicine in the cartridge.  
• Make sure you have the correct pen with correct strength. 
• Check the expiration on the pen label. 
 

 
 



108 

Attaching needle – (Step 2 to 6) 
 
Important: 
• Always use a new needle for each injection. 
• Only use the single-use click-on needles supplied with the pen. 
 
Step 2: 
• Pull off the pen cap. 

 

 
 
Step 3: 
• Pull off the protective foil from the needle. 

 

 
 
Step 4: 
• Click on the needle. 
• You will hear or feel a click when the needle is safely on. 
• You may also screw on the needle. When you feel a light resistance it is safely on. 

 

 
 
Step 5: 
• Pull off the outer needle cap. 
• Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle 

after injecting the medicine. 
 

 
 
Step 6: 
• Pull off the inner needle cap and throw it away. 

 

 
 



109 

Priming – (Step 7 to 9) 
 
• Before using the pen for the first time, you need to remove air bubbles from the cartridge 

(Priming) to receive the correct dose of medicine.  
• Only prime your pen the first time you use it.  
• Perform Step 7 to 9 even if you do not see air bubbles. 
• If the pen has already been used proceed directly to Step 10. 
 
Step 7: 
• Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.  
• If you dial the incorrect priming dose, the priming dose can be corrected either up or down 

without loss of medicine by turning the dose knob in either direction until the symbol of a 
droplet lines up with the dose indicator. 
 

 
 
Step 8: 
• Hold the pen with the needle pointing upwards.  

• Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the 
top of the cartridge. 
 

 
 
Step 9: 
• With the needle still pointing upwards (away from the face) press in the injection button all the 

way in until you see the number ‘0’ lined up with the dose indicator.  
• Check that a droplet of liquid appears at the tip of the needle.  
• If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears. 
• If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle  

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).  
 

 



110 

Dialing the dose – (Step 10) 
 
See “Examples of how to dial a dose” at Page 20 to 211.  
 
Step 10: 
• Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the 

dose display window. 
• The dose can be corrected either up or down without loss of medicine by turning the dose knob 

in either direction until the correct dose lines up with the dose indicator.  
• Do not press the injection button when dialing the dose to avoid loss of medicine. 
 

 
 
Split-dosing: 
• You may need more than one pen to complete your prescribed dose. 
• If you are not able to dial your complete dose, this means there is not enough medicine left in 

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen 
and use a new pen for your injection.  

 
See “Giving a split-dose of REKOVELLE“ at Page 22 to 231 for examples of how to calculate and 
record your split dose. 
 
 
Injecting the dose – (Step 11 to 12) 
 
Important:  
• Do not use the pen if the medicine contains particles or if the medicine is not clear.  
• Read Step 11 and 12 at Page 14 to 151 before giving your injection. 
• This medicine should be given by injection just under the skin (subcutaneously) in the  

stomach-area (abdomen).  
• Use a new injection site for each injection to lower the risk of skin reactions as redness and 

irritation. 
• Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have 

stretch marks. 
 
Step 11 and 12: 
• Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area 

again before you give your injection. 
• Hold the pen so the dose display window is visible during injection.  
• Pinch your skin and insert the needle straight into your skin as shown by your healthcare 

provider. Do not touch the injection button yet. 
• After the needle is inserted, place your thumb on the injection button.  
• Press the injection button all the way in and hold.  
• Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose 

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose. 
 

  



111 

 
• After pressing in the injection button for 5 seconds, release the injection button. Then slowly 

remove the needle from the injection site by pulling it straight out of the skin. 
• If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site. 
 
Note: 
• Do not tilt the pen during injection and removal from skin.  
• Tilting the pen can cause the needle to bend or break off.  
• If a broken needle remains stuck in the body or remains under the skin, get medical help right 

away. 
 
 
Disposal of Needle – (Step 13) 
 
Step 13: 
• Carefully replace the outer needle cap over the needle with a firm push (A). 
• Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).  
• Throw away (dispose of) the used needle carefully (D). 
• See “Disposal” at Page 181.    
 

 
 
Note: 
• Always remove the needle after every use. The needles are for single-use only. 
• Do not store the pen with the needle attached. 
 
 
Replace pen cap – (Step 14) 
 
Step 14: 
• Firmly replace the pen cap on the pen for protection between injections. 
 

 
 
Note: 
• The pen cap will not fit over a needle. 
• If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.  
• If you will use a new pen to give your full prescribed dose instead of giving a split-dose 

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a 
full dose. 

• Keep the pen cap on the pen when it is not in use. 
 
 



112 

Disposal 
 
Needles: 
Put your used needles in a puncture-resistant container, such as a sharps disposal container right away 
after use. Do not throw away (dispose of) your used sharps disposal container in your household trash. 
 
If you do not have a sharps disposal container, you may use a household container that is:  
• made of a heavy-duty plastic,  
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,  
• upright and stable during use,  
• leak-resistant, and  
• properly labeled to warn of hazardous waste inside the container.  
 
When your sharps disposal container is almost full, you will need to follow your community 
guidelines for the right way to dispose of your sharps disposal container. There may be state or local 
laws about how you should throw away used needles. 
 
REKOVELLE pre-filled pens: 
• Throw away (dispose of) your used pens in accordance with local waste regulations. 
 
 
Examples of how to dial a dose 
 
Examples of how to dial a dose using your REKOVELLE pre-filled pen  
The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses, 
and what the dose display window looks like for the prescribed doses.   
 
Examples of 
prescribed dose  
(in micrograms) 

Dose to dial on pen Dose display window for example of prescribed dose 

0.33 0 and 1 line  (Dial to 0 plus 1 click) 
 

0.66 (priming dose) 0 and 2 lines  (Dial to 0 plus 2 clicks) 

 

2.33 2 and 1 line  (Dial to 2 plus 1 click) 
 

11.00 11 (Dial to 11) 
 

12.33 12 and 1 line  (Dial to 12 plus 1 click) 
 

18.66 18 and 2 lines  (Dial to 18 plus 2 clicks) 
 

20.00 20 (Dial to 20) 

 



113 

Giving a split-dose of REKOVELLE 
 
If you are not able to dial the full prescribed dose in your pen, this means that there is not enough 
medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using 
your current pen and the remainder of the dose using a new pen (split-dose injection) or you may 
throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in 
1 injection. If you decide to give a split-dose injection, follow these instructions and write down how 
much medicine to give using the split-dose diary on Page 231. 
 
• Column A shows an example of a prescribed dose. Write down your prescribed dose in column 

A. 
• Column B shows an example of the dose that is left in the pen (this is equal to what you are able 

to dial). 
• Write down the dose that is left in your pen in column B. Give the injection using the rest of the 

medicine that is left in your pen. 
• Prepare and prime a new pen (Step 1 to 9).  
• Calculate and write down the remaining dose to inject in column C by subtracting the number in 

column B from the number in column A. Use a calculator to check your math if needed. 
• See “Examples of how to dial a dose” at Page 20 to 211 if needed. 
• Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For 

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number 
in column C is 9.67, round your remaining dose to 9.66.  

• Call your healthcare provider if you have questions about how to calculate your split-dose. 
• Inject the remaining dose of medicine (the number in column C) using your new pen to 

complete your prescribed dose. 
 
Split-dose diary 
 

 
 
 



114 

Frequently Asked Questions (FAQ) 
 
1. Is the priming step necessary before each injection? 

• No. Priming must be performed only before giving the first injection with a new pen.  
 
2. How do I know that the injection is complete? 

• The injection button is firmly pushed in all the way until it stops. 
• The number ‘0’ is lined up with the dose indicator. 
• You have slowly counted to 5 while you are still holding the injection button in and the 

needle is still in your skin. 
 
3. Why do I have to count to 5 while holding the injection button? 

• Holding the injection button for 5 seconds allows for the full dose to be injected and 
absorbed under your skin. 

 
4. What if the dose knob cannot be turned to the required dose? 

• The cartridge in the pen may not have enough medicine left to deliver the prescribed 
dose. 

• The pen does not allow you to dial a larger dose than the dose that is left in the cartridge. 
• You can inject the medicine left in the pen and complete the prescribed dose with a new 

pen (split-dose) or use a new pen to give the full prescribed dose. 
 
 
Warnings 
 
• Do not use a pen if it has been dropped or hit against hard surfaces.  
• If the injection button is not easy to push in, do not use force. Change the needle. If the injection 

button still is not easy to push in after changing the needle, use a new pen.  
• Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or 

local representative of the marketing authorisation holder (please refer to patient information 
leaflet for contact details). 

 
 
Additional information 
 
Needles 
Needles are supplied with your pen. If you need additional needles contact your healthcare provider. 
Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider 
prescribes. 
 
Contact 
If you have any questions or problems related to the pen, contact your healthcare provider or local 
representative of the marketing authorisation holder (please refer to patient information leaflet for 
contact details). 
 
 
 
 
 
 
 
 
 
 
 
 

1. Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET