FOLLISTIM AQ (follitropin beta injection) is approved for women to help healthy ovaries to develop and release mature eggs. FOLLISTIM AQ is also for women participating in an assisted reproductive technology (ART) program to help the ovaries produce more mature eggs. FOLLISTIM AQ is also approved for men to help bring about the production and development of sperm.

Important Safety Information About FOLLISTIM AQ:

• Do not use FOLLISTIM AQ if you are allergic to recombinant human follicle-stimulating hormone (FSH) products; have a high level of FSH in your blood indicating that your ovaries (women only) or testes (men only) may be permanently damaged and do not work at all; have uncontrolled thyroid, pituitary or adrenal gland problems; are allergic to streptomycin or neomycin (types of antibiotics); have a tumor of the hypothalamus, pituitary gland, breast, uterus (women only) or ovary (women only), or testis (men only); are a women who is pregnant or think you may be pregnant; have heavy or irregular vaginal bleeding and the cause is not known; have ovarian cysts or enlarged ovaries not due to polycystic ovary syndrome (PCOS).

• FOLLISTIM AQ may cause serious side effects in women including ovarian enlargement and ovarian hyperstimulation syndrome (OHSS). OHSS is a serious medical problem that can happen when the ovaries are over-stimulated. In rare cases, it has caused death. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call you healthcare provider right away if you have pain in your lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output or trouble breathing.

• FOLLISTIM AQ can cause you to have fluid in your lungs (atelectasis) and trouble breathing (acute respiratory distress syndrome).

• FOLLISTIM AQ may increase your chance of having blood clots in your blood vessels. Blood clots can cause blood vessel problems (thrombophlebitis), stroke, loss of your arm or leg, blood clot in your lungs (pulmonary embolus), or heart attack.

• FOLLISTIM AQ may increase the chance of twisting of the ovaries in women with certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of the ovary could cause the blood flow to the ovary to be cut off.

• FOLLISTIM AQ can cause multiple births. Having a pregnancy with more than one baby at a time increases the health risk for you and your babies. Discuss your chances of multiple births with your healthcare provider.

• A woman's age, certain sperm problems, genetic background of both parents and a pregnancy with multiple babies can increase the chance that your baby might have birth defects.

• The chance of a pregnancy outside of the womb is increased in women with damaged fallopian tubes.

• The chance of loss of an early pregnancy may be increased in women who have difficulty with becoming pregnant at all.

• The most common side effects of FOLLISTIM AQ in women include cyst in the ovary and stomach pain. The most common side effects of FOLLISTIM AQ in men include headache, pain at the injection site, bruising, swelling or redness at the injection site, breast enlargement and acne.

• For more information, ask your healthcare provider or pharmacist.

• Call your healthcare provider immediately if you get worsening or strong abdominal pain. Also, call your healthcare provider immediately if this happens some days after the last injection has been given.

• Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

• Be sure that you read, understand, and follow the "Patient Instructions for Use" that come with FOLLISTIM AQ. Use FOLLISTIM AQ exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much FOLLISTIM AQ to use, how to inject it, and how often it should be injected. Do not inject FOLLISTIM AQ at home until your healthcare provider has taught you the right way. Do not mix FOLLISTIM AQ with any other medicines in the same vial or in the same syringe. Do not change your dose of FOLLISTIM AQ unless your healthcare provider tells you to. Call your healthcare provider immediately if you use too much FOLLISTIM AQ. If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying important patient information for Follistim AQ Vial.

Please see accompanying important patient information for Follistim AQ Cartridge.

PREGNYL is approved to induce ovulation and pregnancy in women who have problems with ovulation and who have been appropriately pretreated with human menopausal gonadotropins (medications containing follicle-stimulating hormone [FSH] and luteinizing hormone [LH]). PREGNYL will not help women whose ovaries do not work at all (primary ovarian failure).

Important Safety Information About PREGNYL:

• Do not use PREGNYL if you are allergic to human chorionic gonadotropin (HCG).

• PREGNYL should be used in conjunction with human menopausal gonadotropins.

• PREGNYL should only be prescribed by physicians experienced in infertility treatments.

• Anaphylaxis has been reported with urinary-derived HCG products.

• PREGNYL may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases, it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. OHSS may occur after treatment with PREGNYL. Call your healthcare professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, diarrhea, reduced urine output, or trouble breathing.

• PREGNYL may also cause rupture of ovarian cysts resulting in internal bleeding (hemoperitoneum), multiple births, and artery blockage by a blood clot (arterial thromboembolism).

• Other side effects with PREGNYL include headache, irritability, restlessness, depression, fatigue, edema, and pain at the site of injection.

• Hypersensitivity reactions, both localized and systemic in nature, have been reported.

• If you get any side effects that concern you, call your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying important Product Information and discuss it with your doctor.

Ganirelix Acetate Injection is approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Important Safety Information About Ganirelix:

• Do not use Ganirelix Acetate Injection if you are allergic to Ganirelix Acetate or any of its components, gonadotropin releasing hormone (GnRH) or any other GnRH analog (including GnRH agonists and antagonists), or if you are pregnant or think you might be pregnant.

• Ganirelix Acetate Injection should only be prescribed by physicians experienced in infertility treatments. Before starting treatment with Ganirelix, pregnancy must be excluded.

• Hypersensitivity (allergic) reactions, some severe, have been reported after the first dose of Ganirelix Acetate Injection. Call your healthcare professional right away if you get any of the following symptoms: hives, difficulty breathing, chest tightness, high or low blood pressure, vomiting or diarrhea. The packaging of this product contains natural rubber latex that may cause allergic reactions.

• Ganirelix Acetate Injection may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are over-stimulated. In rare cases, it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. Call your healthcare professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain or reduced urine output.

• Other side effects with Ganirelix Acetate Injection include abdominal pain, death of unborn child, headache, vaginal bleeding, injection site reaction and nausea.

If you get any side effects that concern you, call your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying important patient information for Ganirelix Acetate Injection.