Cetrorelix

Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

• 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
• No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS)
• Administration Cetrorelix acetate for Injection 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor
• Directions for using Cetrorelix Acetate for Injection 0.25 mg with the enclosed needles and pre-filled syringe: 1
• Wash hands thoroughly with soap and water. 2
• Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. 3
• Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. 4
• Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. 5
• Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues
• Avoid forming bubbles. 6. …

• Cetrorelix acetate for injection is contraindicated under the following conditions: 1
• Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. 2
• Known hypersensitivity to GnRH or any other GnRH analogs. 3
• Known or suspected pregnancy, and lactation (see PRECAUTIONS). 4
• Severe renal impairment

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).

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. …

There have been no reports of overdosage with cetrorelix acetate for injection 0.25 mg or 3 mg in humans. Single doses up to 120 mg cetrorelix acetate for injection have been well tolerated in patients treated for other indications without signs of overdosage.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.