Gonal-f RFF Pen

Call your doctor for instructions if you miss a dose of follicle stimulating hormone.

For all patients taking Gonal-f RFF Pen (follitropin alfa):

• If you have an allergy to follitropin alfa or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• 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 Gonal-f RFF Pen 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 this medicine.

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 Gonal-f RFF Pen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

For all patients taking Gonal-f RFF Pen (follitropin alfa):

• Tell all of your health care providers that you take Gonal-f RFF Pen. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• 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 this medicine. 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 may be raised. Talk with your doctor.
• 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 Gonal-f RFF Pen, call your doctor 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 Gonal-f RFF Pen (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 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.
• Blood clots have happened with this medicine. 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 very bad side effect that may happen in some women who use Gonal-f RFF Pen. Call your doctor right away if you have very bad stomach pain or bloating; very upset stomach, throwing up, or loose stools (diarrhea); a big weight gain; shortness of breath; or change in how much urine is passed.

Men:

• Enlarged breasts.

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.
• Belly pain.
• Gas.
• Loose stools (diarrhea).
• 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.