Cetrorelix

Generic name: cetrorelix (injectable)
Brand name: Cetrotide
Dosage form: subcutaneous powder for injection (0.25 mg; 3 mg)
Drug class: Gonadotropin-releasing hormone antagonists

What is cetrorelix?

Cetrorelix is a prescription medicine that is used to help women get pregnant. Cetrorelix may be given to you for other reasons.

Description

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:

Before taking cetrorelix, tell your doctor:

• If you are allergic to cetrorelix; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease.
• If you are pregnant or may be pregnant. Do not take cetrorelix if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take cetrorelix.

This is not a list of all drugs or health problems that interact with cetrorelix.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take cetrorelix with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take cetrorelix?

• Tell all of your health care providers that you take cetrorelix. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need to have ultrasounds done while using cetrorelix. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• Do not take cetrorelix if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting cetrorelix.
• Do not take cetrorelix if you are 65 or older. Talk with your doctor.

How is cetrorelix best taken?

Use cetrorelix as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin in the belly area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Use right away after mixing.
• Do not give into skin within 1 inch of the belly button.
• Move the site where you give the shot with each shot.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of cetrorelix that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Cough.
• Very bad dizziness or passing out.
• Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use cetrorelix. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.

What are some other side effects of cetrorelix?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Redness or swelling where the shot is given.
• Itching where the shot is given.
• Upset stomach.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out cetrorelix?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – KIT CARTON