Gonal-F®(follitropin alfa)

GONAL-F is a prescription medicine containing follicle-stimulating hormone (FSH).

GONAL-F is used in:

Infertile women to:

• help healthy ovaries develop (mature) and release an egg to help you get pregnant
• cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

Infertile men to:

• help develop and produce mature sperm

• is allergic to recombinant human FSH or any of the ingredients in GONAL-F
• has a high level of FSH in your blood that show your ovaries (women only) or testes (men only) do not work at all
• has uncontrolled thyroid, adrenal, or pituitary problems
• has a tumor in your sex organs (uterus, ovaries, or testes) or breasts
• has a tumor in your brain, such as a tumor in your pituitary gland or hypothalamus

Do not use GONAL-F if you are a woman that:

• has abnormal bleeding from your uterus or vagina from an unknown cause
• has ovarian cysts or large ovaries from an unknown cause

• have or have had asthma
• have been told by a healthcare provider that you have an increased risk for blood clots (thrombosis)
• have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot (thrombosis)
• have had stomach (abdominal) surgeries

Before you start using GONAL-F and are a woman, tell your healthcare provider if you:

• have had twisting of your ovary (ovarian torsion)
• had or have a cyst on your ovary
• have polycystic ovarian disease
• are pregnant or think you may be pregnant. GONAL-F is not for pregnant women. Your healthcare provider will give you a pregnancy test before you start using GONAL-F.
• are breastfeeding. It is not known if GONAL-F passes into your breast milk. You and your healthcare provider should decide if you will take GONAL-F or breastfeed. You should not do both.
• are not an adult. GONAL-F is not for children. It is not known if GONAL-F is safe or works in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• Read the "Instructions for Use" that comes with GONAL-F for information about the right way to use GONAL-F.
• Use GONAL-F exactly as your healthcare provider tells you to.
• GONAL-F is given by injection under your skin. You can inject GONAL-F under the skin in your stomach (abdomen), upper arm, or upper leg.
• Do not inject GONAL-F at home until your healthcare provider has taught you the right way to inject it.
• Change your injection site as your healthcare provider showed you.
• Do not change your dose or the time you are scheduled to use GONAL-F unless your healthcare provider tells you to.
• If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
• Your healthcare provider will do blood and urine hormone tests while you are using GONAL-F. Make sure you follow-up with your healthcare provider to have your blood and urine tested when told to do so.
• Call your healthcare provider if you have any questions about your dose or how to use GONAL-F.

Women:

• Your healthcare provider may do ultrasound scans of your ovaries. Make sure you follow-up with your healthcare provider to have your ultrasound scans.

Men:

• Your healthcare provider may test your semen while you are using GONAL-F. Make sure you follow-up with your healthcare provider to give a semen sample for testing.

This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda