This medication contains follicle-stimulating hormone (FSH) and is used to treat certain fertility problems in women and men. In women, follitropin alfa helps stimulate healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) to bring about the growth and release of a mature egg (ovulation). In men, this medication helps stimulate healthy testes to produce sperm. It is also used in combination with hCG.

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure) or for men whose testes no longer make sperm properly (primary testicular failure).

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using follitropin alfa and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin or into a muscle as directed by your doctor. The injection is given in the upper arms, thighs, or abdomen. The dosage is based on your medical condition, response to treatment, and labs.

If the medication is stored in the refrigerator, allow the medication to reach room temperature before use. Do not shake the vial. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed.

Headache, mild stomach/abdominal pain, diarrhea, bloating, redness/pain at the injection site, acne, or breast tenderness/pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• bleeding from the vagina/uterus
• flu-like symptoms (such as fever, chills, muscle ache, tiredness)
• swelling of ankles/hands/feet

Get medical help right away if you have any very serious side effects, including:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden severe headache
• trouble speaking
• weakness on one side of the body
• sudden vision changes

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other fertility problems (such as primary ovarian failure or testicular failure)
• abnormal bleeding from the vagina/uterus
• thyroid problems
• adrenal gland problems
• cancer of the reproductive organs (such as breast, uterus, ovary, testis)
• tumor in the brain (such as pituitary tumor)
• ovarian cysts or enlarged ovaries
• blood clots
• stroke
• certain heart diseases (such as angina, heart attack)
• lung problems (such as asthma)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Multiple births may occur as a result of this treatment. Consult your doctor for more details.

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• gonadorelin

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as vaginal ultrasound, hormone levels, liver tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator or at room temperature away from light. Do not freeze. Once vial is mixed, discard any unused portion after 28 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.