Uses of Follistim AQ:

• 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 Follistim AQ?

For all patients taking Follistim AQ (follitropin beta):

• If you are allergic to Follistim AQ (follitropin beta); any part of Follistim AQ (follitropin beta); 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, cancer where hormones make it grow, pituitary gland disease, or thyroid gland disease.
• If you have breast cancer, talk with your doctor.

Women:

• 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 your ovaries no longer make eggs (primary ovarian failure).
• If you are not able to get pregnant because of problems with your sex organs.
• If you are pregnant or may be pregnant. Do not take Follistim AQ (follitropin beta) if you are pregnant.

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 Follistim AQ (follitropin beta).

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 Follistim AQ (follitropin beta) 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 Follistim AQ?

For all patients taking Follistim AQ (follitropin beta):

• Tell all of your health care providers that you take Follistim AQ (follitropin beta). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow up with the doctor as you have been told.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.

Women:

• You will need to have ultrasounds done while using Follistim AQ (follitropin beta). 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.
• 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.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Follistim AQ) best taken?

Use Follistim AQ (follitropin beta) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• 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 Follistim AQ (follitropin beta) 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.

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 Follistim AQ (follitropin beta):

• 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.
• Pale skin.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Blood clots have happened with Follistim AQ (follitropin beta). 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 Follistim AQ (follitropin beta). 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 Follistim AQ?

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:

For all patients taking Follistim AQ (follitropin beta):

• Irritation where the shot is given.
• Upset stomach.
• Pimples (acne).
• Headache.
• Feeling tired or weak.

Women:

• Pelvic pain.
• Stomach pain.

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 Follistim AQ?

All products:

• Store unopened containers in a refrigerator. Do not freeze.
• If needed, you may store unopened containers at room temperature for up to 3 months. If stored at room temperature and not used within 3 months, throw Follistim AQ (follitropin beta) away.
• 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.

Cartridges:

• Once a needle is put into the rubber, store in a refrigerator or at room temperature. Throw away any part not used after 28 days.

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 Follistim AQ (follitropin beta), 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.