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Side Effects & Adverse Reactions
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).
Legal Issues
There is currently no legal information available for this drug.
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
History
There is currently no drug history available for this drug.
Other Information
Cetrotide® (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. The molecular formula is Acetyl-D-3-(2´-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3´-pyridyl)-alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base. The structural formula is as follows:
Cetrorelix acetate
(Ac-D-Nal1-D-Cpa2-D-Pal3-Ser4-Tyr5-D-Cit6-Leu7-Arg8-Pro9-D-Ala10-NH2) |
Cetrotide® (cetrorelix acetate for injection) 0.25 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, USP (pH 5-8), that comes supplied in a 1.0 mL pre-filled syringe. Each vial of Cetrotide® 0.25 mg contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol.
Sources
Cetrotide Manufacturers
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Emd Serono, Inc.
Cetrotide | Emd Serono, Inc.
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. 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).
AdministrationCetrotide® 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor.
Directions for using Cetrotide® 0.25 mg with the enclosed needles and pre-filled syringe:
Wash hands thoroughly with soap and water. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues. Avoid forming bubbles. Draw the total contents of the vial into the syringe. If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial. Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge). Invert the syringe and push the plunger until all air bubbles have been expelled. Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel. Choose a different injection site each day to minimize local irritation. Use the second alcohol swab to clean the skin at the injection site and allow alcohol to dry. Gently pinch up the skin surrounding the site of injection. Inject the prescribed dose as directed by your doctor, nurse or pharmacist. Use the syringe and needles only once. Dispose of the syringe and needles properly after use. If available, use a medical waste container for disposal.
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