Who should not use Cetrorelix Acetate for Injection?

Do not use Cetrorelix Acetate for Injection if you:

• have kidney disease
• are allergic to cetrorelix acetate, mannitol or exogenous peptide hormones (medicines similar to cetrorelix acetate for injection) or
• are pregnant, or think that you might be pregnant, or if you are breast-feeding.

Before starting Cetrorelix Acetate for Injection, 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.

Consult your doctor before taking Cetrorelix Acetate for Injection if you have had severe allergic reactions.

What is the most important information I should know before starting Cetrorelix Acetate for Injection?
Your doctor will confirm you are not pregnant.

How should you use Cetrorelix Acetate for Injection?
You may self-inject Cetrorelix Acetate for Injection after special instruction from your doctor.

What do you do if you have used too much Cetrorelix Acetate for Injection?
Contact your doctor in case of overdosage immediately to check whether an adjustment of the further ovarian stimulation procedure is required.

What are the possible side effects of Cetrorelix Acetate for Injection?
Allergic reactions including anaphylactic reaction with the first dose. Treatment with Cetrorelix Acetate for Injection is not advised in women with severe allergic conditions.

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 side effect not mentioned here or if you are unsure about the effect of this medicine.

These are not all of the possible side effects of Cetrorelix Acetate for Injection. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of Cetrorelix Acetate for Injection, contact the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Cetrorelix Acetate for Injection used for?
Cetrorelix Acetate for Injection is a prescription medicine used to block 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. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation during controlled ovarian stimulation.

This Important Safety Information does not include all the information needed to use Cetrorelix Acetate for Injection safely and effectively. To learn more about Cetrorelix Acetate for Injection, talk to your doctor or pharmacist. Please see full prescribing information for Cetrorelix Acetate for Injection. Please see full prescribing information for Cetrorelix Acetate for Injection at www.fresenius-kabi.com/us.