Cetrorelix Acetate For Injection
Generic Name: cetrorelix acetate for injection
Brand Names:
Cetrorelix Acetate
DESCRIPTION Cetrorelix Acetate for Injection is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10.
Overview
DESCRIPTION Cetrorelix Acetate for Injection is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10.
Uses
INDICATIONS AND USAGE Cetrorelix Acetate for Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Dosage
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. Cetrorelix Acetate for Injection 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase. Cetrorelix Acetate for Injection 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.
Side Effects
ADVERSE REACTIONS The safety of cetrorelix acetate for injection in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrorelix Acetate for Injection was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of cetrorelix acetate for injection treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate for injection treated subjects undergoing COS.
Interactions
Drug Interactions No formal drug interaction studies have been performed with cetrorelix acetate for injection.
Warnings
WARNINGS Cetrorelix Acetate for Injection should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate for injection, pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS ). CONTRAINDICATIONS 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
Pregnancy
Pregnancy (see CONTRAINDICATIONS ) Cetrorelix Acetate for Injection 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 time the recommended human therapeutic dose based on body surface area). However, a dose of 139 μg/kg (approximately 4 times the human dose) resulted in a resorption rate and a post implantation loss of 100%.
Storage
Storage Store cetrorelix acetate for injection 0.25 mg refrigerated, 2°C to 8°C (36°F to 46°F). Store the packaged tray in the outer carton in order to protect from light.
Frequently Asked Questions
What is Cetrorelix Acetate For Injection used for?▼
INDICATIONS AND USAGE Cetrorelix Acetate for Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
What are the side effects of Cetrorelix Acetate For Injection?▼
ADVERSE REACTIONS The safety of cetrorelix acetate for injection in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrorelix Acetate for Injection was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of cetrorelix acetate for injection treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate for injection treated subjects undergoing COS.
Can I take Cetrorelix Acetate For Injection during pregnancy?▼
Pregnancy (see CONTRAINDICATIONS ) Cetrorelix Acetate for Injection 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 time the recommended human therapeutic dose based on body surface area). However, a dose of 139 μg/kg (approximately 4 times the human dose) resulted in a resorption rate and a post implantation loss of 100%.
What are the important warnings for Cetrorelix Acetate For Injection?▼
WARNINGS Cetrorelix Acetate for Injection should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate for injection, pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS ). CONTRAINDICATIONS 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
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.