Uses of Follitropin Alfa:

• It is used to help women get pregnant.
• It is used to help make sperm.

What do I need to tell my doctor BEFORE I take Follitropin Alfa?

For all patients taking follitropin alfa:

• If you are allergic to follitropin alfa; any part of follitropin alfa; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.

Women:

• If your ovaries no longer make eggs (primary ovarian failure).
• If you have any of these health problems: A tumor in your female organs, enlarged ovaries or ovarian cysts, or vaginal bleeding where the cause is not known.
• If you are pregnant or may be pregnant. Do not take follitropin alfa if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

Men:

• If you are not able to make sperm or you have a tumor in your male organs.

This is not a list of all drugs or health problems that interact with follitropin alfa.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take follitropin alfa with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Follitropin Alfa?

For all patients taking follitropin alfa:

• Tell all of your health care providers that you take follitropin alfa. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.

Women:

• You will need to have ultrasounds done while using follitropin alfa. Talk with your doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• If your ovaries get too big, your doctor may tell you that you need to avoid sex. This may cause an ovarian cyst to burst. Talk with your doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• The rate of pregnancy loss (miscarriage) is higher in women using drugs like this one than in women who have a natural pregnancy. Talk with the doctor.
• If you have used drugs like this one more than 1 time to get pregnant, the chance of having tumors in your ovaries or other sex organs may be raised.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking follitropin alfa, call your doctor right away.

How is this medicine (Follitropin Alfa) best taken?

Use follitropin alfa as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• Move the site where you give follitropin alfa as you were told by the doctor.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Vials:

• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.

Prefilled pen and multidose vial:

• If stored in a refrigerator, let follitropin alfa come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat follitropin alfa.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking follitropin alfa:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Breast pain.
• A heartbeat that does not feel normal.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Pale skin.
• Swelling of belly.
• Mood changes.
• Severe lung problems have happened with follitropin alfa. Rarely, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough, or fever.
• Blood clots have happened with follitropin alfa. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

Women:

• Vaginal bleeding that is not normal.
• Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use follitropin alfa. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.

Men:

• Enlarged breasts.

What are some other side effects of Follitropin Alfa?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Upset stomach.
• Pimples (acne).
• Headache.
• Stomach pain or diarrhea.
• Gas.
• Feeling tired or weak.
• Nose or throat irritation.
• Back pain.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Follitropin Alfa?

Vials:

• Store at room temperature or in a refrigerator. Do not freeze.

Single-dose container:

• Use right away after mixing.
• Throw away any part left over after the dose is given.

Multi-dose container:

• After mixing, throw away any part not used after 28 days.

Prefilled pen:

• Store in a refrigerator. Do not freeze.
• You may also store follitropin alfa at room temperature. If stored at room temperature, throw away after 3 months, unless the expiration date comes first.
• After first use, store in a refrigerator or at room temperature. Do not freeze. Throw away any part not used after 28 days.

All products:

• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about follitropin alfa, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.