Cetrorelix (Subcutaneous)

Cetrorelix is a man-made hormone that prevents the effects of Gonadotropin Releasing Hormone (GnRH). GnRH controls another hormone called luteinizing hormone (LH), which starts ovulation during the menstrual cycle. Sometimes, during hormone treatment, premature ovulation can happen, causing eggs that are not ready for fertilization to be released. Cetrorelix stops these eggs from being released too early.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks you with an ultrasound examination during regular visits to ensure that you are ready for an injection of another drug (HCG) to trigger ovulation.

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

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Cetrorelix is not intended for patients over the age of 65 years.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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
• severe pelvic pain
• rapid weight gain
• shortness of breath
• swelling of lower legs

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may have ways to help prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• injection site bruising, itching, swelling, or redness
• nausea

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cetrotide

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Antagonist

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the 0.25 mg vials in the refrigerator. Store the 3 mg vials at room temperature.