Ganirelix


Generic Medicine Info
Indications and Dosage
Subcutaneous
Controlled ovarian hyperstimulation for assisted reproduction in infertility
Adult: As an adjunct to inhibit premature luteinising hormone surges: 250 mcg once daily during the mid to late portion of the follicular phase (e.g. day 5 or 6) after initiating FSH on day 2 or 3 of the menstrual cycle. Initiation of treatment may be delayed in the absence of follicular growth. Treatment should be continued daily until the day of hCG administration. Refer to detailed product guidelines for the specific instructions on administration, timing of inj, and duration of use.
Renal Impairment
Moderate to severe: Contraindicated.
Hepatic Impairment
Moderate to severe: Contraindicated.
Contraindications
Hypersensitivity to ganirelix, latex, or to any of its excipients; hypersensitivity to GnRH or any other GnRH analogue. Moderate to severe renal or hepatic impairment. Pregnancy and lactation.
Special Precautions
Patient with signs and symptoms of active, severe allergic conditions.
Adverse Reactions
Significant: Ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy, congenital malformations. Very rarely, hypersensitivity reactions (e.g. anaphylaxis, anaphylactoid shock, angioedema, urticaria).
Gastrointestinal disorders: Nausea, abdominal pain.
General disorders and administration site conditions: Inj site reactions, malaise.
Reproductive system and breast disorders: Vaginal bleeding, pelvic pain.
Parenteral/SC: X
Monitoring Parameters
Obtain ultrasound to assess follicle size. Verify pregnancy status prior to initiation of treatment. Monitor for signs and symptoms of hypersensitivity.
Action
Description: Ganirelix, a gonadotrophin-releasing hormone (GnRH) antagonist, competitively blocks the gonadotropin-release hormone receptors on the pituitary gonadotroph and transduction pathway, resulting to a rapid, profound, reversible suppression of gonadotrophin and luteinising hormone secretion, thus preventing ovulation until the follicles are of adequate size.
Duration: <48 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: 91.1%. Time to peak plasma concentration: 1.1 hours.
Distribution: Volume of distribution: 43.7 L (single dose); 76.5 L (multiple doses). Plasma protein binding: 81.9%.
Metabolism: Metabolised in the liver via enzymatic hydrolysis into 2 primary metabolites (1-4 and 1-6 peptide).
Excretion: Mainly via faeces (approx 75%) within 288 hours; urine (approx 22%) within 24 hours. Elimination half-life: 12.8 hours (single dose); 16.2 hours (multiple doses).
Chemical Structure

Chemical Structure Image
Ganirelix

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 16130957, Ganirelix. https://pubchem.ncbi.nlm.nih.gov/compound/Ganirelix. Accessed May 26, 2022.

Storage
Store between 15-30°C. Protect from light. Storage recommendations may vary among individual products (refer to specific product guidelines).
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01CC01 - ganirelix ; Belongs to the class of anti-gonadotropin-releasing hormones. Used in hypothalamic hormone preparations.
References
Anon. Ganirelix. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/05/2022.

Anon. Ganirelix. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/03/2022.

Buckingham R (ed). Ganirelix Acetate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/03/2022.

Fyremadel (Ferring Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/03/2022.

Joint Formulary Committee. Ganirelix. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/03/2022.

Orgalutran 0.25 mg/0.5 mL Solution for Injection (Organon Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/03/2022.

Orgalutran 0.25 mg/0.5 mL Solution for Injection (Organon Pharma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/03/2022.

Organon New Zealand Limited. Orgalutran 250 mcg/0.5 mL Solution for Injection data sheet 16 August 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 30/03/2022.

Disclaimer: This information is independently developed by MIMS based on Ganirelix from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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