In the U.S.—

• Infertility

Cetrorelix ( set-RO-rel-lix) is a man-made hormone that blocks the effects of Gonadotropin Releasing Hormone (GnRH). GnRH controls another hormone that is called luteinizing hormone (LH), which is the hormone that starts ovulation during the menstrual cycle. When undergoing hormone treatment sometimes premature ovulation can occur, leading to eggs that are not ready for fertilization to be released. Cetrorelix does not allow the premature release of these eggs to occur.

This medicine is available only with your doctor's prescription, in the following dosage form:

Parenteral
• For injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cetrorelix, the following should be considered:

Allergies—Tell your health care professional if you have ever had any unusual or allergic reaction to cetrorelix, extrinsic peptide hormones (medicines similar to cetrorelix), mannitol, or any GnRH or GnRH-related medicines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Cetrorelix is not recommended during pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant, or may become pregnant.

Breast-feeding—It is not known whether cetrorelix passes into the breast milk. However, it is not recommended during breast–feeding because it may cause unwanted effect in nursing babies.

Older adults—Cetrorelix is not intended for use in patients over the age of 65 years.

• Kidney disease—May increase your chance of side effects from cetrorelix.

Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day.

• Read the paper with information for the patient carefully.
• Understand and use the proper method of safely preparing the medicine.
• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe. Remember to change the site of injection to different areas to prevent skin problems from developing.
• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of cetrorelix . Cetrorelix often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of cetrorelix is given. Your doctor will give you this medicine or arrange for you to get this medicine at the right time.

Dosing—

The dose of cetrorelix may be different for different patients. If you are receiving cetrorelix at home, follow your doctor's orders or the directions on the label. The following information includes only the average doses of cetrorelix. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For treatment of female infertility:
    • Adults—3 milligrams (mg) injected under the skin one time on Day 7 of your menstrual cycle, or 0.25 mg injected under the skin starting on Day 5 or 6 of your menstrual cycle and continuing until HCG administration occurs.

Missed dose—

If you miss a dose of this medicine, discuss with your doctor when you should receive your next dose. Do not double doses. If you have any questions about this, check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Keep the packaged tray in the outer carton to protect it from light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store the 0.25 mg vials in the refrigerator , keep from freezing.
• Store the 3 mg vials at room temperature.

It is very important that your doctor check you using ultrasound examination at regular visits to make sure that you are ready for injection with another drug (HCG) to induce ovulation.

Call your doctor immediately if you have taken more of the medication than your doctor ordered..

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Abdominal or stomach pain;  continuing or severe nausea, vomiting or diarrhea;  decreased amount of urine;  feeling of indigestion;  moderate to severe bloating;  pelvic pain, severe ;  rapid weight gain;  shortness of breath;  swelling of lower legs 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Headache;  injection site bruising, itching, swelling, or redness;  nausea 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.