Important Risk Information for Ovidrel^® PreFilled Syringe (choriogonadotropin alfa injection)

Who should not use Ovidrel^® PreFilled Syringe?

Ovidrel^® Pre-Filled Syringe should not be used in patients:

• With allergies to hCG or any other ingredients in the medication
• With primary ovarian failure (the ovaries no longer produce eggs)
• With uncontrolled thyroid or adrenal disease
• Cancer of the brain such as pituitary tumor
• With a history of abnormal bleeding from the uterus or vagina
• With swollen, enlarged, or painful ovaries
• With cancer of the sex organs
• Who are pregnant 

Before starting Ovidrel^®, 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 taking Ovidrel^®?

• Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention and/or abdominal pain may occur in patients treated with FSH and hCG. 
• Ovarian Hyperstimulation Syndrome (OHSS) may progress rapidly from uncomplicated ovarian enlargement and become a serious medical event. Early signs of OHSS include severe pelvic pain, nausea, vomiting, and weight gain. Call your doctor right away if you think you might be having symptoms of OHSS.
• Treatment with Ovidrel^® may result in becoming pregnant with more than one baby.
• Blood clots may result from treatment with Ovidrel^®.
• It is not known whether this drug is present in human milk. Because many drugs are excreted in human milk, tell your doctor if you are nursing.

What are the most common side effects of Ovidrel^® Pre-Filled Syringe?

The most common side effects in women using Ovidrel^® Pre-Filled Syringe include abdominal pain, nausea, and vomiting. Needle injections may cause some discomfort.

These are not all the possible side effects of Ovidrel^®. 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 Ovidrel^® Pre-Filled Syringe (choriogonadotropin alfa injection)?

Ovidrel^® Pre-Filled Syringe (choriogonadotropin alfa injection) is indicated for the final egg maturation to get ready for egg retrieval. Women who receive Ovidrel^® have undergone pituitary desensitization and have been appropriately pre-treated with follicle stimulating hormone (FSH) as a part of an Assisted Reproductive Technology (ART) program such as in vitro (IVF) fertilization and embryo transfer.

Ovidrel^® Pre-Filled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in infertile patients who do not ovulate, and in whom the cause of infertility is functional and not due to primary ovarian failure.

 For complete information, please see full Prescribing information here.