Drugs List

Therapeutic Indications

Uses

Controlled ovarian stimulation: Prevention of premature ovulation

Administration

Ganirelix should be administered by subcutaneous injection preferably in the upper leg. The injection site must be varied to prevent lipoatrophy.

Ganirelix and FSH should be administered at approximately the same time but using different injection sites.

Contraindications

Breastfeeding
Moderate hepatic impairment
Moderate renal impairment
Pregnancy

Precautions and Warnings

Allergic disposition

Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex
Do not mix with other drugs or substances
Rotate injection sites to minimise the risk of lipoatrophy
Monitor for signs and symptoms of allergic reaction
May exacerbate inflammatory conditions of the skin
Ovarian hyperstimulation syndrome can occur
Discontinue if hypersensitivity reactions occur
Luteal phase support should be provided in accordance to local practice

The safety and efficacy of ganirelix treatment in women weighing less than 50 kg or more than 90 kg have not been established. Pharmacodynamic studies have shown a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (greater than 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. Pharmacokinetic analysis indicates an inverse relationship body weight and serum concentrations of ganirelix.

Hypersensitivity reactions such as anaphylaxis, angioedema and urticaria have been reported. Discontinue treatment if hypersensitivity reactions are suspected.

Pregnancy and Lactation

Pregnancy

Ganirelix is contraindicated in pregnancy.

Animal data have demonstrated litter resorption following exposure to ganirelix at the time of implantation. At the time of writing, there are no adequate studies available regarding the use of ganirelix during pregnancy, and the risk to humans is unknown. Schaefer concurs that information concerning children exposed to ganirelix is rare and inconclusive.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ganirelix is contraindicated in breastfeeding.

It is not known whether ganirelix is excreted in breast milk and at the time of writing, there is no data available regarding the use of ganirelix during breastfeeding. Hale suggests that transfer into milk would be unlikely due to the peptide structure and relatively large molecular weight. Hale also states that it is unlikely to be stable in the gastro-intestinal tract of the infant and not orally bioavailable.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Anaphylaxis
Angioedema
Dyspnoea
Erythema at injection site
Exacerbation of pre-existing eczema
Facial swelling
Headache
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Local reaction at injection site
Malaise
Miscarriage
Nausea
Ovarian hyperstimulation syndrome (OHSS)
Pelvic pain
Rash
Swelling (injection site)
Urticaria

Presentation

Injections of ganirelix.

Drugs List

Therapeutic Indications

Uses

Controlled ovarian stimulation: Prevention of premature ovulation

Dosage

Adults

Additional Dosage Information

Administration

Ganirelix should be administered by subcutaneous injection preferably in the upper leg. The injection site must be varied to prevent lipoatrophy.

Ganirelix and FSH should be administered at approximately the same time but using different injection sites.

Contraindications

Breastfeeding
Moderate hepatic impairment
Moderate renal impairment
Pregnancy

Precautions and Warnings

Allergic disposition

Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex
Do not mix with other drugs or substances
Rotate injection sites to minimise the risk of lipoatrophy
Monitor for signs and symptoms of allergic reaction
May exacerbate inflammatory conditions of the skin
Ovarian hyperstimulation syndrome can occur
Discontinue if hypersensitivity reactions occur
Luteal phase support should be provided in accordance to local practice

The safety and efficacy of ganirelix treatment in women weighing less than 50 kg or more than 90 kg have not been established. Pharmacodynamic studies have shown a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (greater than 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. Pharmacokinetic analysis indicates an inverse relationship body weight and serum concentrations of ganirelix.

Hypersensitivity reactions such as anaphylaxis, angioedema and urticaria have been reported. Discontinue treatment if hypersensitivity reactions are suspected.

Pregnancy and Lactation

Pregnancy

Ganirelix is contraindicated in pregnancy.

Animal data have demonstrated litter resorption following exposure to ganirelix at the time of implantation. At the time of writing, there are no adequate studies available regarding the use of ganirelix during pregnancy, and the risk to humans is unknown. Schaefer concurs that information concerning children exposed to ganirelix is rare and inconclusive.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ganirelix is contraindicated in breastfeeding.

It is not known whether ganirelix is excreted in breast milk and at the time of writing, there is no data available regarding the use of ganirelix during breastfeeding. Hale suggests that transfer into milk would be unlikely due to the peptide structure and relatively large molecular weight. Hale also states that it is unlikely to be stable in the gastro-intestinal tract of the infant and not orally bioavailable.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Anaphylaxis
Angioedema
Dyspnoea
Erythema at injection site
Exacerbation of pre-existing eczema
Facial swelling
Headache
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Local reaction at injection site
Malaise
Miscarriage
Nausea
Ovarian hyperstimulation syndrome (OHSS)
Pelvic pain
Rash
Swelling (injection site)
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Fyremadel 0.25 mg/0.5 ml solution for injection. Ranbaxy UK Ltd. Revised April 2020.

Summary of Product Characteristics: Orgalutran 0.25 mg/0.5 ml solution for injection. Merck Sharp & Dohme Limited. Revised April 2016.