Important Risk Information for Cetrotide^® (cetrorelix acetate for injection)

Who should not use Cetrotide^®?

• Patients that are allergic to cetrorelix acetate, mannitol, or exogenous peptide hormones (medicines similar to Cetrotide^®) should not use Cetrotide^®. 
  
• If you have had severe allergic reactions to any drugs in a previous IVF cycle, tell your doctor.
• Cetrotide^® should not be used in patients who are pregnant, think they might be pregnant, or are breastfeeding.
• Cetrotide^® should not be used in patients with kidney disease.

Before starting Cetrotide^®, tell your healthcare professional about all your medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What is the most important information I should know before starting Cetrotide^®?

• Your doctor will confirm you are not pregnant.

What are the possible side effects of Cetrotide^®?

Cetrotide^® may cause serious side effects including:

• Allergic reactions including anaphylactic reaction with the first dose. Treatment with Cetrotide^® is not advised in women with severe allergic conditions.
• Your doctor should review with you the risks and benefits of using Cetrotide^®. 
• It is not known if Cetrotide^® is excreted in human milk. Because the effects of Cetrotide^® on nursing mothers or the nursing infant are not known, do not use Cetrotide^® if you are breastfeeding.

Common side effects of using Cetrotide^® include:

• Mild and short-lasting reactions may occur at the injection site like reddening, itching, and swelling. Nausea and headache have also been reported.

Call your doctor if you have any other side effect or if you are unsure about the effect of this medicine.

These are not all the possible side effects of Cetrotide^®. For more information, read the product labeling, and ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1‐800‐FDA‐1088.

Indication

What are the uses of Cetrotide^®?

Cetrotide^® blocks the effects of a natural hormone, called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle.

Cetrotide^® blocks undesirable premature ovulation. Premature ovulation may lead to eggs that are not available for egg retrieval.

 For complete information, please see full Prescribing information here.