Cetrorelix Acetate Solution for injection

What is this medicine?

CETRORELIX (set RO rel lix) is used to regulate hormone responses in women undergoing infertility treatment.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• an unusual or allergic reaction to cetrorelix, mannitol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. The success of your fertility treatments depends on proper use of this medication. Call your doctor or health care professional if you are unable to keep an appointment. If you are giving your own injections, do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• herbal or dietary supplements, like black cohosh or DHEA

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

Your doctor will need to monitor your hormone levels in your blood and use an ultrasound to check your response to this medicine. Try to keep all of your appointments. The timing of these tests in relation to taking your medication may be important.

Stop taking this medicine at once and contact your doctor or health care professional if you think you are pregnant.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• nausea and vomiting along with severe abdominal pain

• pelvic pain or bloating

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• hot flashes (flushing of skin, increased sweating)

• itching, redness or mild pain at site where injected

• mild nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store the 0.25 mg injection in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Store the 3 mg injection at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from direct light and heat. Keep in the packaged tray and inside the carton until ready to use. Throw away any unused medicine after the expiration date.