Follitropin Alfa (fol-i-TROE-pin AL-fa)

Treats infertility.

Brand Name(s):

Gonal-F, Gonal-F RFF

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This medicine is usually given in the stomach, upper arm, or upper leg.
• Check the solution in the vial. It should be clear and colorless. Do not use if it is cloudy, discolored, or contains large particles.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Gonal-F®: Store the unused powder in the refrigerator or at room temperature. Protect from light. You may store the mixed medicine in the refrigerator or at room temperature. Throw away unused mixed medicine after 28 days.
• Gonal-F RFF®: Store the unused powder in the refrigerator or at room temperature. Protect from light. Use this medicine right away after mixing. Throw away unused mixed medicine.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.
• Tell your doctor if you are breastfeeding, or if you have liver disease, heart disease, or a history of breathing problems (including asthma), blood clots, stroke, ovary problems, or stomach surgery.
• This medicine may cause the following problems:
  • Ovary problems (including ovarian hyperstimulation syndrome, twisting or enlargement of the ovaries, ovarian cancer)
  • Lung or breathing problems
  • Blood clots
  • Increased risk of ectopic pregnancy or miscarriage
• Talk to your doctor about the possibility that this medicine could cause you to get pregnant with twins, triplets, or multiple babies.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Semen testing and ultrasound examinations will also be needed to check for unwanted effects.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Diarrhea, nausea, vomiting, stomach pain
• Numbness or weakness in your arm, leg, or on one side of your body, pain in your lower leg (calf)
• Severe menstrual-like cramps, bloating, passing gas, vaginal bleeding, weight gain
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Acne, dandruff, oily skin
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Swelling of the breasts or breast soreness in both females and males

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088