Finished product reference

Cetrorelix

Injection, Powder, for Solution · Parenteral · 250 µg

List code
5291
0

Indications

INDICATIONS AND USAGE Cetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. Cetrotide ® (cetrorelix acetate for injection) 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase. Cetrotide ® 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration. When assessment by ultrasound shows a sufficient number of follicles of adequate size, hCG is administered to induce ovulation and final maturation of the oocytes.

Contraindications

CONTRAINDICATIONS Cetrotide ® (cetrorelix acetate for injection) is contraindicated under the following conditions: Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. Known hypersensitivity to GnRH or any other GnRH analogs. Known or suspected pregnancy, and lactation (see PRECAUTIONS ). Severe renal impairment

Warnings and precautions

WARNINGS Cetrotide ® (cetrorelix acetate for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with Cetrotide ® , pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS ).

Pregnancy

Pregnancy (see CONTRAINDICATIONS ) Cetrotide ® is contraindicated in pregnant women. When administered to rats for the first seven days of pregnancy, cetrorelix acetate did not affect the development of the implanted conceptus at doses up to 38 μg/kg (approximately 1 times the recommended human therapeutic dose based on body surface area).

Storage and supply

Storage Store Cetrotide ® 0.25 mg refrigerated, 2ºC - 8ºC (36ºF - 46ºF). Store the packaged tray in the outer carton in order to protect from light.

Source: Cetrorelix Acetate (Cetrotide) — US FDA prescribing information, 2025-09-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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