Cetrorelix

Registered South African indications:

• Prevention of premature ovulation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Severe renal impairment

Cautions

• Mild to moderate renal impairment
• Hepatic impairment
• Elderly
• Active allergic conditions
• Known history of allergic predisposition
• Ovarian Hyperstimulation Syndrome (OHSS)

Forms avail. in SA and covered in this monograph: inj

Prevention of premature ovulation
-In patients undergoing a controlled ovarian stimulation followed by oocyte pick-up and assisted reproductive techniques

0.25mg (Multiple dose regimen)

• SC: 0.25mg, dly (approx. 5-6 days after the start of ovarian stimulation)

If administered as a morning dose: continue throughout the gonadotropin treatment period including the day of ovulation induction 

If administered as an evening dose: continue throughout the gonadotropin treatment period until the evening prior to ovulation induction 

3mg (Single dose regimen)

• SC: 3mg, as a single dose, on day 7 of ovarian stimulation (approx. 132-144hrs after the start of ovarian stimulation)

THEN

• If follicle growth does not allow ovulation induction on the fifth day after 3mg injection, additionally 0.25mg injection should be given, dly, beginning 96hrs after the injection of the 3mg until the day of ovulation induction

See additional prescribing points

The first administration should be performed under the supervision of a physician

Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes

Not indicated for use in children

Pregnancy

• Contraindicated
• Cetrorelix is not intended to be used during pregnancy

Breastfeeding

• Contraindicated
• Cetrorelix is not intended to be used during breastfeeding and lactation

Fertility

• Studies in animals have indicated that cetrorelix exerts a dose-related influence on fertility, reproductive performance, and pregnancy. No teratogenic effects occurred with the medicinal product was administered during the sensitive phase of gestation

Renal Impairment

• Mild to moderate: Caution; no information available 
• Severe: Contraindicated

Hepatic Impairment

• Caution; no information available

Elderly

• Not indicated for use in geriatric patients

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Headache

Gastrointestinal Disorders

• Nausea

Genitourinary Disorders

• Mild to moderate ovarian hyperstimulation syndrome

Skin and Subcutaneous Tissue Disorders

• Local reactions at the injection site

Immune, Blood and Lymphatic System Disorders

• Systemic allergic/pseudo-allergic reactions 

No information available

Signs and symptoms of ovarian hyperstimulation

• In clinical trials, cetrorelix was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy

Multiple dose regimen
-Administration in the morning

• Treatment with cetrorelix 0.25mg should commence on day 5 or 6 of ovarian stimulation (approximately 96-120hrs after the start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.

-Administration in the evening

• Treatment with cetrorelix 0.25mg should commence on day 5 of ovarian stimulation (approximately 96-108hrs after the start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.

Single dose regimen

• If hCG is not administered within 4 days, continue cetrorelix at 0.25mg/day until hCG is administered

Cetrorelix is a luteinising hormone releasing hormone (LHRH) antagonist. LHRH binds to membrane receptors on pituitary cells. Cetrorelix competes with the binding of endogenous LHRH to these receptors. Due to this mode of action cetrorelix controls the secretion of gonadotropins luteinising hormone (LH) and follicle stimulating hormone(FSH). Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland. In females, cetrorelix delays the LH surge and consequently the ovulation.

Injection (per vial) 0.25mg

• Cetrotide (Merck) originator

Injection (per vial) 3mg

• Cetrotide (Merck) originator (Discontinued: 31/10/2018)