Luveris

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

Luveris 75 IU powder and solvent for solution for injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One vial contains 75 IU of lutropin alfa (recombinant human Luteinising Hormone {r-hLH}). 
Lutropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder and solvent for solution for injection.

Appearance of the powder: white lyophilised pellet
Appearance of the solvent: clear colourless solution

The pH of the reconstituted solution is 7.5-8.5.

Presentations other than ampoules should be considered for self administration by patients.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Luveris in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the 
stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH 
deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l. 

4.2 Posology and method of administration

Treatment with Luveris should be initiated under the supervision of a physician experienced in the 
treatment of fertility problems.

Posology
In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to 
develop a single mature Graafian follicle from which the oocyte will be liberated after the 
administration of human chorionic gonadotropin (hCG). Luveris should be given as a course of daily 
injections simultaneously with FSH. Since these patients are amenorrhoeic and have low endogenous 
oestrogen secretion, treatment can commence at any time.

Luveris should be administered concomitantly with follitropin alfa.

Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size 
by ultrasound and oestrogen response. A recommended regimen commences at 75 IU of lutropin alfa 
(ie. one vial of Luveris) daily with 75-150 IU FSH. 

In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa. If an 
FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day 
intervals and preferably by 37.5 IU-75 IU increments. It may be acceptable to extend the duration of 
stimulation in any one cycle to up to 5 weeks.



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When an optimal response is obtained, a single injection of 250 microgramsof r-hCG or 5,000 IU to 
10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections. The 
patient is recommended to have coitus on the day of, and on the day following, hCG administration.

Alternatively, intrauterine insemination (IUI) may be performed.

Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) 
after ovulation may lead to premature failure of the corpus luteum.

If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should 
recommence in the next cycle at a dose of FSH lower than that of the previous cycle.

Special populations

Older people
There is no relevant indication for the use of Luveris in the elderly population. Safety and
effectiveness of Luveris in elderly patients have not been established.

Renal and hepatic impairment
Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment
have not been established.

Paediatric population
There is no relevant indication for the use of Luveris in the paediatric population.

Method of administration
Luveris is intended for subcutaneous use. The first injection of Luveris should be performed under 
direct medical supervision. The powder should be reconstituted immediately prior to use with the 
solvent provided. Self-administration of this medicinal product should only be performed by patients 
who are well-motivated, adequately trained and with access to expert advice.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Luveris is contraindicated in patients with:
 hypersensitivity to active substances or to any of the excipients listed in section 6.1.
 tumours of the hypothalamus and pituitary gland
 ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of 

unknown origin 
 gynaecological haemorrhages of unknown origin
 ovarian, uterine, or mammary carcinoma 

Luveris must not be used when a condition exists which would make a normal pregnancy impossible, 
such as:
 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

Before starting treatment, the couple's infertility should be assessed as appropriate and putative 
contraindications for pregnancy evaluated. In addition, patients should be evaluated for 
hypothyroidism, adrenocortical deficiency and hyperprolactinemia and appropriate specific 
treatment given.



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Porphyria
In patients with porphyria or a family history of porphyria Luveris may increase the risk of an acute 
attack. Deterioration or a first appearance of this condition may require cessation of treatment.

Ovarian Hyperstimulation Syndrome (OHSS)
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is 
more commonly seen in women 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.

Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, or 
enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound 
evidence of ascites or marked ovarian enlargement.

Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea 
or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, 
electrolyte imbalances, ascites, pleural effusions, 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.

Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian 
syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol 
levels and previous episodes of OHSS, large number of developing ovarian follicles and large number 
of oocytes retrieved in ART cycles.

Adherence to recommended Luveris and FSH dosage and regimen of administration can minimise the 
risk of ovarian hyperstimulation. Monitoring of stimulation cycles by ultrasound scans as well as 
estradiol measurements are recommended to early identify risk factors.

There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may 
be more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian 
hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain 
from coitus or use barrier contraceptive methods for at least 4 days. As OHSS may progress rapidly 
(within 24 hours) or over several days to become a serious medical event, patients should be followed 
for at least two weeks after hCG administration.

Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended 
that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and 
appropriate therapy be started.

Ovarian torsion
Ovarian torsion has been reported after treatment with other gonadotropins. This 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 ovarian syndrome. Damage to the ovary due to 
reduced blood supply can be limited by early diagnosis and immediate detorsion.

Multiple pregnancy
In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births is 
increased compared with natural conception. The majority of multiple conceptions are twins. Multiple 
pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.

To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is 
recommended.



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In patients undergoing Assisted Reproductive Technology (ART) procedures the risk of multiple 
pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.

Pregnancy loss
The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing 
stimulation of follicular growth for ovulation induction 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 was reported to be higher than in the general population.

Congenital malformations
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous 
conceptions. This could be due to parental factors (e.g. maternal age, genetics), ART procedures and 
multiple pregnancies.

Thromboembolic events
In women with recent or ongoing thromboembolic disease or women with generally recognised risk 
factors for thromboembolic events, such as personal or family history, thrombophilia or severe obesity 
(body mass index >30 kg/m2), 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 carries an increased risk of thromboembolic events.

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. It is not yet 
established whether or not treatment with gonadotropins increases the risk of these tumours in 
infertile women.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Luveris should not be administered as a mixture with other medicinal products, in the same injection, 
except follitropin alfa for which studies have shown that co-administration does not significantly alter 
the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.

4.6 Fertility, pregnancy and lactation

Pregnancy
There is no indication for the use of Luveris during pregnancy.
Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on 
pregnancy, embryonal or foetal development, parturition or postnatal development following 
controlled ovarian stimulation. No teratogenic effect of Luveris has been observed in animal studies. 
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of 
Luveris.

Breast-feeding
Luveris is not indicated during breast-feeding. 

Fertility
Luveris is indicated for the stimulation of follicular development, in association with FSH (see 
section 4.1).



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4.7 Effects on ability to drive and use machines

Luveris has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile
Luveris is used for the stimulation of follicular development in association with follitropin alfa. In this 
context, it is difficult to attribute adverse reactions to any one of the substances used.

In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or 
swelling) were reported in 7.4 % and 0.9 % of the injections, respectively. No severe injection site 
reactions were reported. 

Ovarian Hyper-Stimulation Syndrome (OHSS) was observed in less than 6 % of patients treated with 
Luveris. No severe OHSS was reported (section 4.4).

In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have 
been associated with human menopausal gonadotropin therapy. Although these adverse reactions were 
not observed, there is the possibility that they may also occur with Luveris.

Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease.

List of adverse reactions
The following definitions apply to the frequency terminology used hereafter: very common 
(≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

The following adverse reactions may be observed after administration of Luveris.

Immune system disorders
Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.

Nervous system disorders
Common: Headache

Vascular disorders
Very rare: Thromboembolism, usually associated with severe OHSS

Gastrointestinal disorders
Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea.

Reproductive system and breast disorders
Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, 
pelvic pain

General disorders and administration site conditions:
Common: Injection site reaction (e.g. pain, erythema, haematoma, swelling and/or irritation at the site 
of injection)

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.



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4.9 Overdose

The effects of an overdose of Luveris are unknown. Nevertheless there is a possibility that OHSS may 
occur, which is further described in section 4.4.

Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers 
without serious adverse reactions and were well tolerated.

Management
Treatment is directed to symptoms.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins. ATC 
code: G03GA07

Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH), a glycoprotein composed of non-
covalently bound α- and ß-subunits. Luteinising Hormone (LH) binds on the ovarian theca (and 
granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotropin 
hormone (hCG). This LH/CG transmembrane receptor is a member of the super-family of G protein-
coupled receptors; specifically, it has a large extra-cellular domain. In vitro the affinity binding of 
recombinant hLH to the LH/CG receptor on Leydig tumour cells (MA-10) is between that for hCG 
and that of pituitary hLH, but within the same order of magnitude.

In the ovaries, during the follicular phase, LH stimulates theca cells to secrete androgens, which will 
be used as the substrate by granulosa cell aromatase enzyme to produce estradiol, supporting 
FSH-induced follicular development. At mid-cycle, high levels of LH trigger corpus luteum formation 
and ovulation. After ovulation, LH stimulates progesterone production in the corpus luteum by 
increasing the conversion of cholesterol to pregnenolone. 

In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the 
primary effect resulting from administration of lutropin alfa is an increase in estradiol secretion by the 
follicles, the growth of which is stimulated by FSH.

In clinical trials, patients were defined by an endogenous serum LH level < 1.2 IU/l as measured in a 
central laboratory. However, it should be taken into account that there are variations between LH 
measurements performed in different laboratories.

In these trials the ovulation rate per cycle was 70-75 %. 

5.2 Pharmacokinetic properties

The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers 
from 75 IU up to 40,000 IU. The pharmacokinetic profile of lutropin alfa is similar to that of urinary-
derived hLH. 

Absorption
Following subcutaneous administration, the absolute bioavailability is approximately 60 %.

Distribution
Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of 
approximately one hour. The steady state volume of distribution is around 10-14 l. The mean 
residence time is approximately 5 hours.



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Lutropin alfa shows linear pharmacokinetics, as assessed by area under curve (AUC) which is directly 
proportional to the dose administered. The lutropin alfa pharmacokinetics following single and 
repeated administration of Luveris are comparable and the accumulation ratio of lutropin alfa is 
minimal. There is no pharmacokinetic interaction with follitropin alfa when administered 
simultaneously.

Elimination
Following subcutaneous administration of Luveris, lutropin alfa is eliminated from the body with a 
terminal half-life of about 10-12 hours. Following subcutaneous administration, the terminal half-life 
is slightly prolonged. Total body clearance is around 2 l/h with less than 5 % of the dose being 
excreted in the urine. 

5.3 Preclinical safety data

Non clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. As expected from the 
heterologous protein nature of the hormone, lutropin alfa raised an antibody response in experimental 
animals after a period that reduced the measurable serum LH levels but did not fully prevent its 
biological action. No signs of toxicity due to the development of antibodies to lutropin alfa were 
observed.

At doses of 10 IU/kg/day and greater, repeated administration of lutropin alfa to pregnant rats and 
rabbits caused impairment of reproductive function including resorption of foetuses and reduced body 
weight gain of the dams. However, drug-related teratogenesis was not observed in either 
animal model.

Other studies have shown that lutropin alfa is not mutagenic.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Powder:
Sucrose
Disodium phosphate dihydrate
Sodium dihydrogen phosphate monohydrate
Polysorbate 20
Phosphoric acid, concentrated (for pH adjustment)
Sodium hydroxide (for pH adjustment)
L-methionine
Nitrogen

Solvent:
Water for injection

6.2 Incompatibilities

This medicinal product must not be administered as a mixture in the same injection with other 
medicinal products except follitropin alfa.

6.3 Shelf life

3 years.



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6.4 Special precautions for storage

Do not store above 25 °C. 
Store in the original package in order to protect from light. 

6.5 Nature and contents of container

The powder is packaged in 3 ml neutral colourless glass (type I) vials. The vials are sealed with 
bromobutyl stoppers protected by aluminium seal rings and flip-off caps. The solvent is packaged 
either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml 
neutral colourless glass (type I) ampoules.

Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules. Not all pack 
sizes may be marketed.

6.6 Special precautions for disposal and other handling

For immediate and single use following first opening and reconstitution.
The powder must be reconstituted with the solvent before use by gentle swirling.
The reconstituted solution should not be administered if it contains particles or is not clear.

Luveris may be mixed with follitropin alfa and co-administered as a single injection.

In this case Luveris should be reconstituted first and then used to reconstitute the follitropin 
alfa powder.

In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with 
one or two ampoule(s)/vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/155/001 (1 vial/ 1 ampoule)
EU/1/00/155/002 (3 vials/ 3 ampoules)
EU/1/00/155/003 (10 vials/ 10 ampoules)
EU/1/00/155/004 (1 vial/ 1 vial)
EU/1/00/155/005 (3 vial/ 3 vials)
EU/1/00/155/006 (10 vials/ 10 vials)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29th November 2000.
Date of latest renewal: 30th November 2005.



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10. DATE OF REVISION OF THE TEXT

11/2014

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.



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ANNEX II

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER(S) 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



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

Name and address of the manufacturer of the biological active substance
Merck Serono SA
CH-1170 Aubonne
Switzerland

Name and address of the manufacturer responsible for batch release
Merck Serono S.p.A.
Via delle Magnolie 15 (Zona industriale)
I-70026 Modugno (Bari)
Italy

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and  published on the European medicines web-portal.

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.

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.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time.



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ANNEX III

LABELLING AND PACKAGE LEAFLET



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A. LABELLING



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
LUVERIS 75 IU, VIALS

1. NAME OF THE MEDICINAL PRODUCT

Luveris 75 IU powder and solvent for solution for injection
Lutropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Composition: one vial of powder contains: lutropin alfa 75 IU.

3. LIST OF EXCIPIENTS

Other ingredients: polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium 
phosphate dihydrate, phosphoric acid concentrated, sodium hydroxide, L-methionine and nitrogen.

One ampoule of solvent contains: 1 ml water for injection. (EU/1/00/155/001-003)
One vial of solvent contains: 1 ml water for injection. (EU/1/00/155/004-006)

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder for solution for injection / 1 ampoule of solvent.
3 vials of powder for solution for injection / 3 ampoules of solvent.
10 vials of powder for solution for injection / 10 ampoules of solvent.
1 vial of powder for solution for injection / 1 vial of solvent.
3 vials of powder for solution for injection / 3 vials of solvent.
10 vials of powder for solution for injection / 10 vials of solvent.

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



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9. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C. Store in the original package in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/155/001 (1 vial/ 1 ampoule)
EU/1/00/155/002 (3 vials/ 3 ampoules)
EU/1/00/155/003 (10 vials/ 10 ampoules)
EU/1/00/155/004 (1 vial/ 1 vial)
EU/1/00/155/005 (3 vial/ 3 vials)
EU/1/00/155/006 (10 vials/ 10 vials)

13. BATCH NUMBER

Batch
Solvent Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

luveris 75 iu

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.



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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN:
NN:



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LUVERIS 75 IU, VIALS

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Luveris 75 IU
Powder for injection
Lutropin alfa
Subcutaneous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

75 IU

6. OTHER



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LUVERIS 75 IU, SOLVENT AMPOULES

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for Luveris
Water for injection
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LUVERIS 75 IU, SOLVENT VIALS

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for Luveris
Water for injection
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER



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B. PACKAGE LEAFLET



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Package leaflet: Information for the user
Solvent in ampoules

Luveris 75 IU powder and solvent for solution for injection
Lutropin alfa

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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Luveris is and what it is used for
2. What you need to know before you use Luveris
3. How to use Luveris
4. Possible side effects
5. How to store Luveris
6. Contents of the pack and other information

1. What Luveris is and what it is used for

What Luveris is
Luveris is a medicine containing lutropin alfa, a recombinant Luteinising Hormone (LH) which is 
essentially similar to the hormone found naturally in humans, but is made by means of biotechnology. 
It belongs to the family of hormones called gonadotropins, which are involved in the normal control of 
reproduction.

What Luveris is used for
Luveris is recommended for the treatment of adult women who have been shown to produce very low 
levels of some of the hormones involved in the natural reproductive cycle. The medicine is used 
together with another hormone called Follicle Stimulating Hormone, (FSH), to bring about the 
development of follicles, which are in the ovary, the structures maturing the eggs (ova). It is followed 
by treatment with a single dose of human Chorionic Gonadotropin (hCG), which leads to the release 
of an egg from the follicle (ovulation).

2. What you need to know before you use Luveris

Do not use Luveris:
 If you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone 

or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in 
section 6).

 If you have cancer of ovaries, uterus or breast.
 If you have had a brain tumour diagnosed.
 If you have ovarian enlargement or sacs of fluid within the ovaries (ovarian cyst) of unknown 

origin.
 If you have unexplained vaginal bleeding.

Do not use Luveris if any of the above applies to you. If you are not sure, talk to your doctor or 
pharmacist before using this medicine.



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Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Luveris.
You and your partner's fertility should be evaluated before the treatment is started.

It is recommended not to use Luveris if you have any condition that usually makes a normal 
pregnancy impossible, such as ovaries that do not work because of a condition called primary ovarian 
failure, or malformations of sexual organs.

Porphyria
Tell your doctor before you start treatment, if you or any member of your family have porphyria (an 
inability to break down porphyrins that may be passed on from parents to children).

Ovarian Hyper-Stimulation Syndrome (OHSS)
This medicine stimulates your ovaries. This increases your risk of developing Ovarian Hyper-
Stimulation Syndrome or OHSS. This is when your follicles develop too much and become large 
cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you 
have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this 
medicine (see in section 4 under “Serious side effects”).

In case you are not ovulating, and if the recommended dose and schedule of administration are 
adhered to, the occurrence of OHSS is less likely. Luveris treatment seldom causes severe OHSS. This 
becomes more likely if the medicine that is used for final follicular maturation (containing human 
Chorionic Gonadotropin, hCG) is administered (see in section 3 under “How much to use” for details). 
If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you 
may be told not to have sex or to use a barrier contraceptive method for at least four days.

Your doctor will ensure careful monitoring of ovarian response, based on ultrasound and blood 
sampling before and during the course of treatment.

Multiple pregnancy
When using Luveris, you have a higher risk of being pregnant with more than one child at the same 
time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may 
lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy 
by using the right dose of Luveris at the right times. When undergoing assisted reproductive 
technology the risk of having a multiple pregnancy is related to your age, the quality and the number 
of fertilised eggs or embryos placed inside you.

Miscarriage
When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, 
you are more likely to have a miscarriage than the average woman.

Ectopic pregnancy
Women with a history of tubal disease are at risk of ectopic pregnancy (pregnancy where the embryo 
is implanted outside the womb), whether the pregnancy is obtained by spontaneous conception or with 
fertility treatments.

Blood clotting problems (thromboembolic events)
Talk to your doctor before using Luveris if you or a member of your family have ever had blood clots 
in the leg or in the lung, or a heart attack or stroke. You may be at a higher risk of serious blood clots 
or existing clots might become worse with Luveris treatment.

Tumours of sexual organs
There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in 
women who have undergone multiple drug regimens for infertility treatment.



24

Birth defects
Birth defects after Assisted Reproductive Technology (ART) may be slightly higher than after 
spontaneous conceptions. This could be due to differences in parental factors like maternal age, 
genetics, as well as the ART procedures and multiple pregnancy.

Children and adolescents
Luveris is not for use in children and adolescents below 18 years old.

Other medicines and Luveris
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other 
medicines.

Do not use Luveris as a mixture with other medicines in the same injection, except for follitropin alfa, 
if prescribed by your doctor.

Pregnancy and breast-feeding
Do not use Luveris if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Luveris has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Luveris
Luveris contains less than 1 mmol sodium (23 mg) per dose. It is essentially “sodium free”.

3. How to use Luveris

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not
sure. 

Using this medicine
Your doctor will decide on the dose and schedule of administration, which are most appropriate for 
you during this course of treatment. 

More user-friendly presentations are available for self administration by patients at home. Consult 
your doctor to find out if a more suitable alternative may be available for you.

How much to use
Luveris is usually used every day for up to three weeks simultaneously with injections of FSH. 
 The usual starting dose is 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH. 
 According to your response, your doctor may increase your dose of FSH by preferably 

37.5-75 IU at 7 to 14-day intervals. 

Your physician may decide to extend your treatment up to 5 weeks.

When the desired response has been obtained, a single injection of hCG is given 24 to 48 hours after 
the last injections of Luveris and FSH. You are recommended to have sexual intercourse on the day of, 
and the day following, administration of the hCG. Alternatively, Intra-Uterine Insemination (IUI) may 
be performed.

If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 
‘Possible Side Effects’). For the following cycle, your doctor will prescribe FSH at a lower dose than 
that of the previous cycle.



25

Method of administration
Luveris is intended for subcutaneous use which means it is given by injection under the skin. Each vial 
is for single use only.

If you administer Luveris to yourself, please carefully read the following instructions:
 Wash your hands. It is important that your hands and the items you use be as clean as possible.

 Assemble everything you need. Find a clean area and lay out everything:
- one vial of Luveris,
- one ampoule of solvent,
- two alcohol swabs, 
- one syringe,
- one reconstitution needle for dissolving the powder in the solvent,
- a fine-bore needle for subcutaneous injection,
- a sharps container for safe disposal of glass and needles.

 Open the ampoule of solvent: On the head of the solvent ampoule, you will see a small 
coloured dot. Directly below it is where the neck of the ampoule has been treated to make it 

easier to break. Gently flick the top section of the ampoule 
so that any fluid in the neck of the ampoule drops into the 
bottom chamber. Now press the ampoule firmly over the 
neck, and break the ampoule away from the coloured dot. 
Carefully place the open ampoule upright on the work-
surface.

 Draw up the solvent: Attach the reconstitution needle to the syringe, with the syringe in 
one hand, pick up the open ampoule, insert the needle and 
draw up all of the solvent.

Carefully set the syringe down on the work-surface, taking 
care not to touch the needle.

 Prepare the injection solution: Remove the protective cap from the Luveris powder vial, pick 
up your syringe and slowly inject the solvent into the vial 
of Luveris. Swirl gently without removing the syringe. Do 
not shake.

 After the powder has dissolved (which usually occurs immediately), check that the resulting 
solution is clear and does not contain any particles. Turn 
the vial upside down and gently draw the solution back into 
the syringe.



26

You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately. 
After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the 
container with the follitropin alfa powder. Once the powder has dissolved, draw the solution back into 
the syringe. Inspect for particles as before, and do not use if the solution is not clear.

Up to 3 containers of powder may be dissolved in 1 ml of solvent.

 Change the needle for the fine-bore needle and remove any air bubbles: If you see air bubbles 
in the syringe, hold the syringe with the needle pointing 
upwards and gently flick the syringe until all the air collects 
at the top. Gently push the plunger until the air bubbles 
are gone.

 Immediately inject the solution: Your doctor or nurse will have already advised you where to 
inject (e.g. tummy, front of thigh). Wipe the chosen area with an alcohol swab. Firmly pinch the

skin together and insert the needle at a 45° to 
90° angle using a dart-like motion. Inject under the 
skin, as you were taught. Do not inject directly into 
a vein. Inject the solution by pushing gently on the 
plunger. Take as much time as you need to inject all 
the solution. Immediately withdraw the needle and 
clean the skin with an alcohol swab using a circular 
motion.

 Dispose of all used items: Once you have finished your injection, immediately discard all 
needles and empty glass containers in the sharps container provided. Any unused solution must 
be discarded.

If you use more Luveris than you should
The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that Ovarian 
Hyper-Stimulation Syndrome may occur, which is further described in ‘Possible side effects'. 
However this will only occur if hCG is administered (see section ‘Warnings and precautions’).

If you forget to use Luveris
Do not use a double dose to make up for a forgotten dose. Please contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects 

Contact your doctor straight away if you notice any of the below listed side effects. The doctor 
might ask you to stop using Luveris.

Allergic reaction
Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can 
sometimes be serious. This side effect is very rare (may affect up to 1 in 10,000 people).



27

Ovarian Hyper-Stimulation Syndrome
 Lower abdominal pain together with nausea or vomiting. These may be the symptoms of 

Ovarian Hyper-Stimulation Syndrome (OHSS). Your ovaries may have over-reacted to the 
treatment and formed large sacs of fluid or cysts (see also in section 2 under “Ovarian Hyper-
Stimulation Syndrome”). This side effect is common (may affect up to 1 in 10 people). If this 
happens, your doctor will need to examine you as soon as possible.

 Serious blood clotting complications (thromboembolic events) usually with severe OHSS are
found very rarely. This could cause chest pain, breathlessness, stroke or heart attack (see also in
section 2 under “Blood clotting problems”).

Other common side effects
 Headache 
 Feeling sick, vomiting, diarrhoea, abdominal discomfort or abdominal pain
 Sacs of fluid within the ovaries (ovarian cysts), breast pain and pelvic pain.
 Local reactions at the injection site, such as pain, itching, bruising, swelling or irritation.

Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, 
there have been rare cases reported following treatment with human menopausal gonadotropin (hMG), 
a urine-derived medication also containing LH.

Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a 
history of prior tubal disease.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Luveris

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 vials after EXP. The expiry date 
refers to the last day of that month.

Do not store above 25° C. Store in the original package in order to protect from light.

Do not use this medicine if you notice any visible signs of deterioration, such as discolouration of the 
powder or damage to the container.

The medicine should be administered immediately after dissolving the powder.

The solution should not be administered if it contains particles or is not clear.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Luveris contains
 The active substance is lutropin alfa. One vial of powder for injection contains 75 IU 

(International Units).
 Lutropin alfa is recombinant human Luteinising Hormone (r-hLH), produced by recombinant 

DNA technology. 



28

 The other ingredients of the powder are polysorbate 20, sucrose, sodium dihydrogen phosphate 
monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, 
L-methionine and nitrogen.

 The solvent is water for injection.

What Luveris looks like and contents of the pack
 Luveris comes as a powder and solvent for solution for injection.
 It is supplied in packs containing 1, 3 or 10 vials of powder, together with the same number of 

solvent ampoules.
 Each vial of powder contains 75 IU of lutropin alfa and each ampoule of solvent contains 1 ml 

of water for injection.

Marketing Authorisation Holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Manufacturer
Merck Serono S.p.A.
Via delle Magnolie 15
(Zona industriale)
I-70026 Modugno (Bari)
Italy

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder.

België/Belgique/Belgien
MERCK NV/SA
Tél/Tel: +32-2-686 07 11

Lietuva
Merck Serono UAB 
Tel: +370 37320603

България
„Мерк България“ ЕАД
Teл.: +359 24461 111

Luxembourg/Luxemburg
MERCK NV/SA, Belgique/Belgien
Tél/Tel: +32-2-686 07 11

Česká republika
Merck spol.s.r.o
Tel. +420 272084211

Magyarország
Merck Kft. 
Tel: +36-1-463-8100

Danmark
Merck A/S
Tlf: +45 35253550

Malta
Vivian Corporation Ltd
Tel: +356-22-588600

Deutschland
Merck Serono GmbH
Tel: +49-6151-6285-0

Nederland
Merck BV
Tel: +31-20-6582800

Eesti
Merck Serono OÜ
Tel: +372 682 5882

Norge
Merck Serono Norge 
Tlf: +47 67 90 35 90

Ελλάδα
Merck A.E.
T: +30-210-61 65 100

Österreich
Merck GesmbH.
Tel: +43 1 57600-0



29

España
Merck S.L.
Línea de Información: 900 102 964
Tel: +34-91-745 44 00

Polska
Merck Sp. z o.o.
Tel.: +48 22 53 59 700

France
Merck Serono s.a.s.
Tél.: +33-4-72 78 25 25
Numéro vert : 0 800 888 024

Portugal
Merck, s.a.
Tel: +351-21-361 35 00

Hrvatska
Merck d.o.o,
Tel: +385 1 4864 111

România
Merck România SRL
Tel: +40 21 319 88 50

Íreland
Merck Serono Ltd, United Kingdom
Tel: +44-20 8818 7200

Slovenija
MERCK d.o.o.
Tel: +386 1 560 3 800

Ísland
Icepharma hf
Tel: + 354 540 8000

Slovenská republika
Merck spol. s r.o.
Tel: + 421 2 49 267 111

Italia
Merck Serono S.p.A.
Tel: +39-06-70 38 41

Suomi/Finland
Merck Oy
Puh/Tel: +358-9-8678 700

Κύπρος
Χρ. Γ. Παπαλοϊζου Λτδ
Τηλ.: +357 22490305

Sverige
Merck AB
Tel: +46-8-562 445 00

Latvija
Merck Serono SIA
Tel: +371 67152500

United Kingdom
Merck Serono Ltd
Tel: +44-20 8818 7200

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.



30

Package leaflet: Information for the user
Solvent in vials

Luveris 75 IU powder and solvent for solution for injection
Lutropin alfa

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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Luveris is and what it is used for
2. What you need to know before you use Luveris
3. How to use Luveris
4. Possible side effects
5. How to store Luveris
6. Contents of the pack and other information

1. What Luveris is and what it is used for

What Luveris is
Luveris is a medicine containing lutropin alfa, a recombinant Luteinising Hormone (LH) which is 
essentially similar to the hormone found naturally in humans, but is made by means of biotechnology. 
It belongs to the family of hormones called gonadotropins, which are involved in the normal control of 
reproduction.

What Luveris is used for
Luveris is recommended for the treatment of adult women who have been shown to produce very low 
levels of some of the hormones involved in the natural reproductive cycle. The medicine is used 
together with another hormone called Follicle Stimulating Hormone, (FSH), to bring about the 
development of follicles which are in the ovary, the structures maturing the eggs (ova). It is followed 
by treatment with a single dose of human Chorionic Gonadotropin (hCG), which leads to the release 
of an egg from the follicle (ovulation).

2. What you need to know before you use Luveris

Do not use Luveris:
 If you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone 

or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in 
section 6).

 If you have cancer of ovaries, uterus or breast.
 If you have had a brain tumour diagnosed.
 If you have ovarian enlargement or sacs of fluid within the ovaries (ovarian cyst) of unknown 

origin.
 If you have unexplained vaginal bleeding.

Do not use Luveris if any of the above applies to you. If you are not sure, talk to your doctor or 
pharmacist before using this medicine. 



31

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Luveris.
You and your partner's fertility should be evaluated before the treatment is started.

It is recommended not to use Luveris if you have any condition that usually makes a normal 
pregnancy impossible, such as ovaries that do not work because of a condition called primary ovarian 
failure, or malformations of sexual organs.

Porphyria
Tell your doctor before you start treatment, if you or any member of your family have porphyria (an 
inability to break down porphyrins that may be passed on from parents to children).

Ovarian Hyper-Stimulation Syndrome (OHSS)
This medicine stimulates your ovaries. This increases your risk of developing Ovarian Hyper-
Stimulation Syndrome or OHSS. This is when your follicles develop too much and become large 
cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you 
have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this 
medicine (see in section 4 under “Serious side effects”).

In case you are not ovulating, and if the recommended dose and schedule of administration are 
adhered to, the occurrence of OHSS is less likely. Luveris treatment seldom causes severe OHSS. This 
becomes more likely if the medicine that is used for final follicular maturation (containing human 
Chorionic Gonadotropin, hCG) is administered (see in section 3 under “How much to use” for details). 
If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you 
may be told not to have sex or to use a barrier contraceptive method for at least four days.

Your doctor will ensure careful monitoring of ovarian response, based on ultrasound and blood 
sampling before and during the course of treatment.

Multiple pregnancy
When using Luveris, you have a higher risk of being pregnant with more than one child at the same 
time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may 
lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy 
by using the right dose of Luveris at the right times. When undergoing assisted reproductive 
technology the risk of having a multiple pregnancy is related to your age, the quality and the number 
of fertilised eggs or embryos placed inside you.

Miscarriage
When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, 
you are more likely to have a miscarriage than the average woman.

Ectopic pregnancy
Women with a history of tubal disease are at risk of ectopic pregnancy (pregnancy where the embryo 
is implanted outside the womb), whether the pregnancy is obtained by spontaneous conception or with 
fertility treatments.

Blood clotting problems (thromboembolic events)
Talk to your doctor before using Luveris if you or a member of your family have ever had blood clots 
in the leg or in the lung, or a heart attack or stroke. You may be at a higher risk of serious blood clots 
or existing clots might become worse with Luveris treatment.

Tumours of sexual organs
There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in 
women who have undergone multiple drug regimens for infertility treatment.



32

Birth defects
Birth defects after Assisted Reproductive Technology (ART) may be slightly higher than after 
spontaneous conceptions. This could be due to differences in parental factors like maternal age, 
genetics, as well as the ART procedures and multiple pregnancy.

Children and adolescents
Luveris is not for use in children and adolescents below 18 years old.

Other medicines and Luveris
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other 
medicines.

Do not use Luveris as a mixture with other medicines in the same injection, except for follitropin alfa, 
if prescribed by your doctor.

Pregnancy and breast-feeding
Do not use Luveris if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Luveris has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Luveris
Luveris contains less than 1 mmol sodium (23 mg) per dose.It is essentially “sodium free”.

3. How to use Luveris 

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure.

Using this medicine
Your doctor will decide on the dose and schedule of administration, which are most appropriate for 
you during this course of treatment. 

How much to use
Luveris is usually used every day for up to three weeks simultaneously with injections of FSH. 
 The usual starting dose is 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH. 
 According to your response, your doctor may increase your dose of FSH by preferably 

37.5-75 IU at 7 to 14-day intervals. 

Your physician may decide to extend your treatment up to 5 weeks.

When the desired response has been obtained, a single injection of hCG is given 24 to 48 hours after 
the last injections of Luveris and FSH. You are recommended to have sexual intercourse on the day of, 
and the day following, administration of the hCG. Alternatively, Intra-Uterine Insemination (IUI) may 
be performed.

If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 
‘Possible Side Effects’). For the following cycle, your doctor will prescribe FSH at a lower dose than 
that of the previous cycle.

Method of administration
Luveris is intended for subcutaneous use which means it is given by injection under the skin. Each vial 
is for single use only.



33

If you administer Luveris to yourself, please carefully read the following instructions:
 Wash your hands. It is important that your hands and the items you use be as clean as possible.

 Assemble everything you need. Find a clean area and lay out everything:
- one vial of Luveris,
- one vial of solvent,
- two alcohol swabs, 
- one syringe,
- one reconstitution needle for dissolving the powder in the solvent,
- a fine-bore needle for subcutaneous injection,
- a sharps container for safe disposal of glass and needles.

 Remove the protective cap from the solvent vial. Attach the reconstitution needle to the 
syringe and draw up some air into the syringe by pulling the 
plunger to approximately the 1 ml mark. Then, insert the 
needle into the vial, push the plunger to expel the air, turn 
the vial upside down and gently draw up all the solvent.

Carefully set the syringe down on the work-surface, taking 
care not to touch the needle.

 Prepare the injection solution: Remove the protective cap from the Luveris powder
vial, pick up your syringe and slowly inject the solvent into 
the vial of Luveris. Swirl gently without removing the 
syringe. Do not shake.

 After the powder has dissolved (which usually occurs immediately), check that the resulting 
solution is clear and does not contain any particles. Turn 
the vial upside down and gently draw the solution back into 
the syringe.

You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately. 
After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the 
container with the follitropin alfa powder. Once the powder has dissolved, draw the solution back into 
the syringe. Inspect for particles as before, and do not use if the solution is not clear.

Up to 3 containers of powder may be dissolved in 1 ml of solvent.



34

 Change the needle for the fine-bore needle and remove any air bubbles: If you see air bubbles 
in the syringe, hold the syringe with the needle pointing 
upwards and gently flick the syringe until all the air collects 
at the top. Gently push the plunger until the air bubbles 
are gone.

 Immediately inject the solution: Your doctor or nurse will have already advised you where to 
inject (e.g. tummy, front of thigh). Wipe the chosen area with an alcohol swab. Firmly pinch the

skin together and insert the needle at a 45° to 90° angle using 
a dart-like motion. Inject under the skin, as you were taught. 
Do not inject directly into a vein. Inject the solution by 
pushing gently on the plunger. Take as much time as you 
need to inject all the solution. Immediately withdraw the 
needle and clean the skin with an alcohol swab using a 
circular motion.

 Dispose of all used items: Once you have finished your injection, immediately discard all 
needles and empty glass containers in the sharps container provided. Any unused solution must 
be discarded.

If you use more Luveris than you should
The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that Ovarian 
Hyper-Stimulation Syndrome may occur, which is further described in ‘Possible side effects'. 
However this will only occur if hCG is administered (see section ‘Warnings and precautions’).

If you forget to use Luveris
Do not use a double dose to make up for a forgotten dose. Please contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Contact your doctor straight away if you notice any of the below listed side effects. The doctor 
might ask you to stop using Luveris.

Allergic reaction
Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can 
sometimes be serious. This side effect is very rare (may affect up to 1 in 10,000 people).

Ovarian Hyper-Stimulation Syndrome
 Lower abdominal pain together with nausea or vomiting. These may be the symptoms of 

Ovarian Hyper-Stimulation Syndrome (OHSS). Your ovaries may have over-reacted to the 
treatment and formed large sacs of fluid or cysts (see also in section 2 under “Ovarian Hyper-
Stimulation Syndrome”). This side effect is common (may affect up to 1 in 10 people). If this 
happens, your doctor will need to examine you as soon as possible.

 Serious blood clotting complications (thromboembolic events) usually with severe OHSS are
found very rarely. This could cause chest pain, breathlessness, stroke or heart attack (see also in 
section 2 under “Blood clotting problems”).



35

Other common side effects
 Headache 
 Feeling sick, vomiting, diarrhoea, abdominal discomfort or abdominal pain
 Sacs of fluid within the ovaries (ovarian cysts), breast pain and pelvic pain.
 Local reactions at the injection site, such as pain, itching, bruising, swelling or irritation.

Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, 
there have been rare cases reported following treatment with human menopausal gonadotropin (hMG), 
a urine-derived medication also containing LH.

Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a 
history of prior tubal disease.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Luveris

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 vials after EXP. The expiry date 
refers to the last day of that month.

Do not store above 25° C. Store in the original package in order to protect from light.

Do not use this medicine if you notice any visible signs of deterioration, such as discolouration of the 
powder or damage to the container.

The medicine should be administered immediately after dissolving the powder.

The solution should not be administered if it contains particles or is not clear.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Luveris contains
 The active substance is lutropin alfa. One vial of powder for injection contains 75 IU 

(International Units).
 Lutropin alfa is recombinant human Luteinising Hormone (r-hLH), produced by recombinant 

DNA technology.
 The other ingredients of the powder are polysorbate 20, sucrose, sodium dihydrogen phosphate 

monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, 
L-methionine and nitrogen.

 The solvent is water for injection.

What Luveris looks like and contents of the pack
 Luveris comes as a powder and solvent for solution for injection.



36

 It is supplied in packs containing 1, 3 or 10 vials of powder, together with the same number of 
solvent vials.

 Each vial of powder contains 75 IU of lutropin alfa and each vial of solvent contains 1 ml of 
water for injection.

Marketing Authorisation Holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Manufacturer
Merck Serono S.p.A.
Via delle Magnolie 15
(Zona industriale)
I-70026 Modugno (Bari)
Italy

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder.

België/Belgique/Belgien
MERCK NV/SA
Tél/Tel: +32-2-686 07 11

Lietuva
Merck Serono UAB 
Tel: +370 37320603

България
„Мерк България“ ЕАД
Teл.: +359 24461 111

Luxembourg/Luxemburg
MERCK NV/SA, Belgique/Belgien
Tél/Tel: +32-2-686 07 11

Česká republika
Merck spol.s.r.o
Tel. +420 272084211

Magyarország
Merck Kft. 
Tel: +36-1-463-8100

Danmark
Merck A/S
Tlf: +45 35253550

Malta
Vivian Corporation Ltd
Tel: +356-22-588600

Deutschland
Merck Serono GmbH
Tel: +49-6151-6285-0

Nederland
Merck BV
Tel: +31-20-6582800

Eesti
Merck Serono OÜ
Tel: +372 682 5882

Norge
Merck Serono Norge 
Tlf: +47 67 90 35 90

Ελλάδα
Merck A.E.
T: +30-210-61 65 100

Österreich
Merck GesmbH.
Tel: +43 1 57600-0

España
Merck S.L.
Línea de Información: 900 102 964
Tel: +34-91-745 44 00

Polska
Merck Sp. z o.o.
Tel.: +48 22 53 59 700



37

France
Merck Serono s.a.s.
Tél.: +33-4-72 78 25 25
Numéro vert : 0 800 888 024

Portugal
Merck, s.a.
Tel: +351-21-361 35 00

Hrvatska
Merck d.o.o,
Tel: +385 1 4864 111

România
Merck România SRL
Tel: +40 21 319 88 50

Íreland
Merck Serono Ltd, United Kingdom
Tel: +44-20 8818 7200

Slovenija
MERCK d.o.o.
Tel: +386 1 560 3 800

Ísland
Icepharma hf
Tel: + 354 540 8000

Slovenská republika
Merck spol. s r.o.
Tel: + 421 2 49 267 111

Italia
Merck Serono S.p.A.
Tel: +39-06-70 38 41

Suomi/Finland
Merck Oy
Puh/Tel: +358-9-8678 700

Κύπρος
Χρ. Γ. Παπαλοϊζου Λτδ
Τηλ.: +357 22490305

Sverige
Merck AB
Tel: +46-8-562 445 00

Latvija
Merck Serono SIA
Tel: +371 67152500

United Kingdom
Merck Serono Ltd
Tel: +44-20 8818 7200

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.


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) 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