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Cetrotide

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Cetrotide

Cetrotide

INDICATIONS

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

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) may be administered subcutaneously either once daily (0.25 mg dose) or once (3 mg dose) during the early- to mid-follicular phase.

In the single dose regimen, 3 mg of Cetrotide® (cetrorelix) is administered when the serum estradiol level is indicative of an appropriate stimulation response, usually on stimulation day 7 (range day 5-9). If hCG has not been administered within four days after injection of Cetrotide® (cetrorelix) 3 mg, Cetrotide® (cetrorelix) 0.25 mg should be administered once daily until the day of hCG administration.

In the multiple dose regimen, 0.25 mg of Cetrotide® (cetrorelix) 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

Cetrotide® (cetrorelix) 0.25 mg and 3 mg can be administered by the patient herself after appropriate instructions by her doctor.

Directions for using Cetrotide® (cetrorelix) 0.25 mg and 3 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. 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.
  7. Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge).
  8. Invert the syringe and push the plunger until all air bubbles have been expelled.
  9. Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel. If you are on a multiple dose (0.25 mg) regimen, 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.
  10. Inject the prescribed dose as directed by your doctor, nurse or pharmacist.
  11. 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.

HOW SUPPLIED

Cetrotide® (cetrorelix acetate for injection) 0.25 mg is available in a carton of one packaged tray (NDC 44087-1225-1).

Each packaged tray contains: one glass vial containing 0.26 - 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, USP (pH 5-8), one 20 gauge needle (yellow), one 27 gauge needle (grey), and two alcohol swabs.

Cetrotide® (cetrorelix acetate for injection) 3 mg is available in a carton of one packaged tray (NDC 44087-1203-1). Each packaged tray contains: one glass vial containing 3.12 - 3.24 mg cetrorelix acetate (corresponding to 3 mg cetrorelix), one pre-filled glass syringe with 3 mL of Sterile Water for Injection, USP (pH 5-8), one 20 gauge needle (yellow), one 27 gauge needle (grey), and two alcohol swabs.

Storage

Cetrotide® (cetrorelix) 3 mg: Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Store the packaged tray in the outer carton.

Cetrotide® (cetrorelix) 0.25 mg: Store refrigerated, 2-8C (36-46F). Store the packaged tray in the outer carton.

Manufactured for: EMD Serono, Inc., Rockland, MA 02370, USA. April 2008. FDA Rev date: 4/4/2008

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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