Orgalutran

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



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1. NAME OF THE MEDICINAL PRODUCT

Orgalutran 0.25 mg/0.5 mL solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL aqueous solution. The active substance 
ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring 
gonadotrophin releasing hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of the 
natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)1, D-pClPhe2, D-Pal(3)3, 
D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH with a molecular weight of 1570.4.

Excipient with known effect:

This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say 
essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear and colourless aqueous solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women 
undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) 
or corifollitropin alfa, the sustained follicle stimulant.

4.2 Posology and method of administration

Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.

Posology

Orgalutran is used to prevent premature LH surges in women undergoing COH. Controlled ovarian 
hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses. Orgalutran 
(0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH 
administration or on day 5 or day 6 following the administration of corifollitropin alfa. The starting 
day of Orgalutran is depending on the ovarian response, i.e. the number and size of growing follicles 
and/or the amount of circulating oestradiol. The start of Orgalutran may be delayed in absence of 
follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of 
stimulation.

Orgalutran and FSH should be administered approximately at the same time. However, the
preparations should not be mixed and different injection sites are to be used.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the 
amount of circulating oestradiol (see section 5.1).

 



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Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate 
size are present. Final maturation of follicles can be induced by administering human chorionic 
gonadotrophin (hCG). 

Timing of last injection
Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time 
between the last Orgalutran injection and the hCG injection should not exceed 30 hours, as otherwise a 
premature LH surge may occur. Therefore, when injecting Orgalutran in the morning, treatment with 
Orgalutran should be continued throughout the gonadotrophin treatment period including the day of 
triggering ovulation. When injecting Orgalutran in the afternoon the last Orgalutran injection should 
be given in the afternoon prior to the day of triggering ovulation.

Orgalutran has shown to be safe and effective in women undergoing multiple treatment cycles.

The need for luteal phase support in cycles using Orgalutran has not been studied. In clinical studies, 
luteal phase support was given according to study centres’ practice or according to the clinical 
protocol.

Special populations

Renal impairment
There is no experience on the use of Orgalutran in subjects with renal impairment, as they were 
excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with 
moderate or severe renal impairment (see section 4.3).

Hepatic impairment 
There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were 
excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with 
moderate or severe hepatic impairment (see section 4.3).

Paediatric population
There is no relevant use of Orgalutran in the paediatric population.

Method of administration

Orgalutran should be administered subcutaneously, preferably in the upper leg. The injection site 
should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of 
Orgalutran themselves, provided that they are adequately instructed and have access to expert advice. 

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
 Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.
 Moderate or severe impairment of renal or hepatic function.
 Pregnancy or breast-feeding.

4.4 Special warnings and precautions for use

Hypersensitivity reaction

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases 
of hypersensitivity reactions (both generalised and local), have been reported with Orgalutran, as early 
as with the first dose, during post-marketing surveillance. These events have included anaphylaxis 
(including anaphylactic shock), angioedema and urticaria (see section 4.8). If a hypersensitivity 
reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. In 

 



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the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic 
conditions.

Latex allergy

The needle cover contains dry natural rubber/latex which comes into contact with the needle and may 
cause allergic reactions (see section 6.5).

Ovarian hyperstimulation syndrome (OHSS)

Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. 
OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated 
symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

Ectopic pregnancy

Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), 
often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early 
ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Congenital malformations

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be 
higher than after spontaneous conceptions. This is thought to be due to differences in parental 
characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple 
gestations. In clinical studies investigating more than 1,000 newborns it has been demonstrated that 
the incidence of congenital malformations in children born after COH treatment using Orgalutran is 
comparable with that reported after COH treatment using a GnRH agonist.

Women weighing less than 50 kg or more than 90 kg

The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or 
more than 90 kg (see sections 5.1 and 5.2).

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say 
essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The possibility of interactions with commonly used medicinal products, including histamine liberating 
medicinal products, cannot be excluded.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of ganirelix in pregnant women.
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see 
section 5.3). The relevance of these data for humans is unknown. 

Breast-feeding

It is not known whether ganirelix is excreted in breast milk.

 



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The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see section 4.3).

Fertility

Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in 
assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might 
otherwise occur in these women during the ovarian stimulation.
For posology and method of administration, see section 4.2.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Summary of the safety profile

The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using 
recFSH for ovarian stimulation. The adverse reactions with Orgalutran using corifollitropin alfa for 
ovarian stimulation are expected to be similar.

Tabulated list of adverse reactions

The adverse reactions are classified according to MedDRA system organ class and frequency; very 
common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100). The frequency of 
hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance.

System organ class Frequency Adverse reaction
Immune system disorders Very rare Hypersensitivity reactions (including rash, facial 

swelling, dyspnoea, anaphylaxis (including 
anaphylactic shock), angioedema and urticaria)1

Worsening of a pre-existing eczema2

Nervous system disorders Uncommon Headache

Gastrointestinal disorders Uncommon Nausea

General disorders and 
administration site 
conditions

Very common Local skin reaction at the site of injection 
(predominantly redness, with or without swelling)3

Uncommon Malaise
1 Cases have been reported, as early as with the first dose, among patients administered Orgalutran.
2 Reported in one subject after the first Orgalutran dose.
3 In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local
skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 
25 % in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear 
within 4 hours after administration.

Description of selected adverse reactions

Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for 
ART, notably pelvic pain, abdominal distension, OHSS (see section 4.4), ectopic pregnancy and 
spontaneous abortion.

 



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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

Overdose in humans may result in a prolonged duration of action. 
No data on acute toxicity of Orgalutran in humans are available. Clinical studies with subcutaneous
administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions. In 
acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and 
bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, 
respectively.
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, 
anti-gonadotrophin-releasing hormones, ATC code: H01CC01.

Mechanism of action

Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by 
competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound, 
reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by 
GnRH agonists. Following administration of multiple doses of 0.25 mg Orgalutran to female 
volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74 %, 32 % and 25 % 
at 4, 16 and 16 hours after injection, respectively. Serum hormone levels returned to pre-treatment 
values within two days after the last injection.

Pharmacodynamic effects

In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 
5 days. During Orgalutran treatment the average incidence of LH rises (> 10 IU/L) with concomitant 
progesterone rise (> 1 ng/mL) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment. 
There was a tendency towards an increased incidence of LH and progesterone rises in women with a 
higher body weight (> 80 kg), but no effect on clinical outcome was observed. However, based on the 
small number of patients treated so far, an effect cannot be excluded. 
In case of a high ovarian response, either as a result of a high exposure to gonadotrophins in the early 
follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier 
than day 6 of stimulation. Initiation of Orgalutran treatment on day 5 can prevent these premature LH 
rises without compromising the clinical outcome.

Clinical efficacy and safety

In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference, 
treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of 
stimulation but the final cohort of growing follicles was slightly smaller and produced on average less 
oestradiol. This different pattern of follicular growth requires that FSH dose adjustments are based on 
the number and size of growing follicles, rather than on the amount of circulating oestradiol. Similar 
comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol 
have not been performed.

 

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5.2 Pharmacokinetic properties

Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) 
were similar to those after a single subcutaneous dose. After repeated dosing 0.25 mg/day steady-state 
levels of approximately 0.6 ng/mL were reached within 2 to 3 days.

Pharmacokinetic analysis indicates an inverse relationship between body weight and serum 
concentrations of Orgalutran.

Absorption

After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach 
peak levels (Cmax) of approximately 15 ng/mL within 1 to 2 hours (tmax). The bioavailability of 
Orgalutran following subcutaneous administration is approximately 91 %.

Biotransformation

The major circulating component in plasma is ganirelix. Ganirelix is also the main compound found in 
urine. Faeces only contain metabolites. The metabolites are small peptide fragments formed by 
enzymatic hydrolysis of ganirelix at restricted sites. The metabolite profile of Orgalutran in humans 
was similar to that found in animals.

Elimination

The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 L/h. 
Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %). 

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose 
toxicity and genotoxicity.

Reproduction studies carried out with ganirelix at doses of 0.1 to 10 g/kg/day subcutaneously in the 
rat and 0.1 to 50 g/kg/day subcutaneously in the rabbit showed increased litter resorption in the 
highest dose groups. No teratogenic effects were observed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acetic acid;
Mannitol;
Water for injections. 
The pH may have been adjusted with sodium hydroxide and acetic acid.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

6.3 Shelf life

3 years

 



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6.4 Special precautions for storage

Do not freeze.
Store in the original package in order to protect from light.

6.5 Nature and contents of container

Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, 
aqueous solution closed with a rubber piston that does not contain latex. Each pre-filled syringe is 
affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into 
contact with the needle. (See section 4.4.)

Supplied in cartons containing 1 or 5 pre-filled syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from 
undamaged containers.
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/130/001, 1 pre-filled syringe
EU/1/00/130/002, 5 pre-filled syringes

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17 May 2000
Date of last renewal: 10 May 2010

10. DATE OF REVISION OF THE TEXT

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(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(S) RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturers responsible for batch release

N.V. Organon, 
Kloosterstraat 6
Postbus 20
5340 BH Oss, 
The Netherlands.

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 (PSURs)

The requirements for submission of PSURs 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.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorisation holder (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.

 



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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 AND THE IMMEDIATE 
PACKAGING

OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes 

1. NAME OF THE MEDICINAL PRODUCT

Orgalutran 0.25 mg/0.5 mL solution for injection
ganirelix

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 mL aqueous solution.

3. LIST OF EXCIPIENTS

Other ingredients: acetic acid, mannitol, water for injections, sodium hydroxide and/or acetic acid as 
pH adjustment.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection, 1 pre-filled syringe containing 0.5 mL
Solution for injection, 5 pre-filled syringes each containing 0.5 mL

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

For single use only.
The needle cover contains dry natural rubber/latex which comes into contact with the needle and may 
cause allergic reactions.

8. EXPIRY DATE

EXP 

 



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9. SPECIAL STORAGE CONDITIONS

Do not freeze.
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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/130/001 1 pre-filled syringe
EU/1/00/130/002 5 pre-filled syringes

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 mL

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

Orgalutran 0.25 mg/0.5 mL solution for injection
ganirelix
Subcutaneous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MSD

 



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B. PACKAGE LEAFLET

 



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Package leaflet: Information for the patient

Orgalutran 0.25 mg/0.5 mL solution for injection
ganirelix

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

1. What Orgalutran is and what it is used for

Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “anti-
gonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin 
releasing hormone (GnRH). GnRH regulates the release of gonadotrophins (luteinising hormone (LH) 
and follicle stimulating hormone (FSH)). Gonadotrophins play an important role in human fertility and 
reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. 
Follicles are small round sacs that contain the egg cells. LH is needed to release the mature egg cells 
from the follicles and ovaries (i.e. ovulation). Orgalutran inhibits the action of GnRH, resulting in 
suppression of the release of especially LH.

Orgalutran is used for

In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other 
methods, occasionally ovulation may occur too early causing a significant reduction in the chance of 
getting pregnant. Orgalutran is used to prevent the premature LH surge that might cause such a 
premature release of egg cells.

In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or 
corifollitropin alfa, a follicle stimulant with a long duration of action.

2. What you need to know before you use Orgalutran

Do not use Orgalutran
 if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in 

section 6);
 if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue;
 if you have a moderate or severe kidney or liver disease;
 if you are pregnant or breast-feeding.

 



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Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Orgalutran

Allergic reactions

If you have an active allergic condition, please tell your doctor. Your doctor will decide, depending on 
the severity, if additional monitoring is required during treatment. Cases of allergic reactions have 
been reported, as early as with the first dose.

Allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips 
tongue and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or 
anaphylaxis) have been reported. (See also section 4.) If you have an allergic reaction, stop taking 
Orgalutran and seek immediate medical assistance.

Latex allergy

The needle cover contains dry natural rubber/latex which comes into contact with the needle and may
cause allergic reactions.

Ovarian hyperstimulation syndrome (OHSS)

During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may 
develop. This syndrome is related to the stimulation procedure with gonadotrophins. Please refer to the 
Package Leaflet of the gonadotrophin-containing medicine prescribed for you.

Multiple births or birth defects

The incidence of congenital malformations after assisted reproduction techniques may be slightly 
higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to 
characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm 
characteristics) and to the higher incidence of multiple gestations after assisted reproduction
techniques. The incidence of congenital malformations after assisted reproduction techniques using 
Orgalutran is not different from that after using other GnRH analogues in the course of assisted 
reproduction techniques.

Pregnancy complications

There is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women 
with damaged fallopian tubes.

Women weighing less than 50 kg or more than 90 kg

The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or 
more than 90 kg. Ask your doctor for further information.

Children and adolescents
There is no relevant use of Orgalutran in children or adolescents.

Other medicines and Orgalutran
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility
Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques 
(ART). Do not use Orgalutran during pregnancy and breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

 



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Driving and using machines
The effects of Orgalutran on ability to drive and use machines have not been studied.

Orgalutran contains sodium
Orgalutran contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially 
‘sodium-free’.

3. How to use Orgalutran

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.
Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including 
in vitro fertilisation (IVF).
Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 
of your period. Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 
5 or day 6 of stimulation. Based on your ovarian response, your doctor may decide to start on another 
day. 
Orgalutran and FSH should be administered approximately at the same time. However, the 
preparations should not be mixed and different injection sites are to be used.

Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate 
size are present. Final maturation of the egg cells in the follicles can be induced by administering 
human chorionic gonadotrophin (hCG). The time between two Orgalutran injections as well as the
time between the last Orgalutran injection and hCG injection should not exceed 30 hours, as otherwise 
a premature ovulation (i.e. release of egg cells) may occur. Therefore, when injecting Orgalutran in the 
morning treatment with Orgalutran should be continued throughout the gonadotrophin treatment 
period including the day of triggering ovulation. When injecting Orgalutran in the afternoon the last 
Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation. 

Instructions for use

Injection site
Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin, 
preferably in the upper leg. Inspect the solution before use. Do not use if the solution contains particles 
or is not clear. If you administer the injections yourself or have it done by your partner, follow the 
instructions below carefully. Do not mix Orgalutran with any other medicines.

Preparing the injection site
Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant (for 
example alcohol) to remove any surface bacteria. Clean about 5 cm (two inches) around the point 
where the needle will go in and let the disinfectant dry for at least one minute before proceeding.

Inserting the needle
Remove needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the 
base of the pinched-up skin at an angle of 45° to the skin surface. Vary the injection site with each 
injection.

Checking the correct needle position
Gently draw back the plunger to check if the needle is positioned correctly. Any blood drawn into the 
syringe means the needle tip has penetrated a blood vessel. If this happens, do not inject Orgalutran, 
but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; 
bleeding should stop in a minute or two. Do not use this syringe and dispose of it properly. Start again 
with a new syringe.

 



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Injecting the solution
Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is 
correctly injected and the skin tissues are not damaged.

Removing the syringe
Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
Use the pre-filled syringe only once.

If you use more Orgalutran than you should
Contact your doctor.

If you forget to use Orgalutran
If you realise that you forgot a dose, administer it as soon as possible.
Do not inject a double dose to make up for a forgotten dose.
If you are more than 6 hours late (so the time between two injections is longer than 30 hours) 
administer the dose as soon as possible and contact your doctor for further advice.

If you stop using Orgalutran
Do not stop using Orgalutran unless advised to by your doctor, as this may affect the outcome of your 
treatment.

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.

The chance of having a side effect is described by the following categories:

Very common: may affect more than 1 in 10 women
 Local skin reactions at the site of injection (predominantly redness, with or without swelling). The 

local reaction normally disappears within 4 hours of administration. 

Uncommon: may affect up to 1 in 100 women
 Headache
 Nausea
 Malaise 

Very rare: may affect up to 1 in 10,000 women
 Allergic reactions have been observed, as early as with the first dose.

 Rash
 Facial swelling
 Difficulty breathing (dyspnoea)
 Swelling of face, lips, tongue, and/or throat that may cause difficulty in breathing and/or 

swallowing (angioedema and/or anaphylaxis)
 Hives (urticaria)

 Worsening of a pre-existing rash (eczema) has been reported in one subject after the first 
Orgalutran dose. 

In addition, side effects are reported which are known to occur with controlled ovarian 
hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic 
pregnancy (when the embryo develops outside the womb) and miscarriage (see the patient information 
leaflet of the FSH-containing preparation you are treated with)).

 



21

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

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 carton and on the label after 
‘EXP’. The expiry date refers to the last day of that month.

Do not freeze.
Store in the original package, in order to protect from light.

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from 
undamaged containers.

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 protect the environment.

6. Contents of the pack and other information

What Orgalutran contains
- The active substance is ganirelix (0.25 mg in 0.5 mL solution).
- The other ingredients are acetic acid, mannitol, water for injections. The pH (a measurement of 

the acidity) may have been adjusted with sodium hydroxide and acetic acid.

What Orgalutran looks like and contents of the pack
Orgalutran is a clear and colourless aqueous solution for injection. The solution is ready for use and 
intended for subcutaneous administration. The needle cover contains dry natural rubber/latex
which comes into contact with the needle.

Orgalutran is available in packs of 1 or 5 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder 
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer 
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands.

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

 

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


22

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel: + 370 5 2780247
msd_lietuva@merck.com

България
Мерк Шарп и Доум България ЕООД
Teл.: + 359 2 819 37 37
info-msdbg@merck.com

Luxembourg/Luxemburg
MSD Belgium BVBA/SPRL
Tel/Tél: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft.
Tel.: + 36 1 888 5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 99 99 000 (+ 31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel: + 372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: + 47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel.: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél + 33 (0)1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: + 351 214 465700
inform_pt@merck.com

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: + 40 21 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
msd.slovenia@merck.com

 



23

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: + 421 2 58282010
dpoc_czechslovak@merck.com

Italia
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: + 358 (0)9 804650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673
        (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: + 46 77570 04 88
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67 364224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited 
Tel: + 44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in {month YYYY}.

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(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