Thông tin thuốc gốc
Chỉ định và Liều dùng
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.
Suy thận
Moderate to severe: Contraindicated.
Suy gan
Moderate to severe: Contraindicated.
Chống chỉ định
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.
Thận trọng
Patient with signs and symptoms of active, severe allergic conditions.
Tác dụng không mong muốn
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.
Chỉ số theo dõi
Obtain ultrasound to assess follicle size. Verify pregnancy status prior to initiation of treatment. Monitor for signs and symptoms of hypersensitivity.
Tác dụng
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.
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).
Đặc tính

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 16130957, Ganirelix. Accessed May 26, 2022.

Bảo quản
Store between 15-30°C. Protect from light. Storage recommendations may vary among individual products (refer to specific product guidelines).
Phân loại MIMS
Hormon dinh dưỡng & các thuốc tổng hợp có liên quan
Phân loại ATC
H01CC01 - ganirelix ; Belongs to the class of anti-gonadotropin-releasing hormones. Used in hypothalamic hormone preparations.
Tài liệu tham khảo
Anon. Ganirelix. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. Accessed 24/05/2022.

Anon. Ganirelix. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 30/03/2022.

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

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

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

Orgalutran 0.25 mg/0.5 mL Solution for Injection (Organon Pharma [UK] Limited). MHRA. Accessed 30/03/2022.

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

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