Follitropin Beta (fol-i-TROE-pin BAY-ta)

Treats infertility.

Brand Name(s):

Follistim AQ

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 the skin (for men and women), usually in the stomach or thigh, or into a muscle (for women only).
• 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.
• Use a new needle and syringe each time you inject your medicine.
• Do not mix this medicine with other medicines in the same vial or syringe.
• It is very important that you keep track of each dose you inject. This will prevent skin problems. Do not inject into skin areas that are tender, red, bruised, or hard. Your doctor or nurse will help you with this.
• Follitropin beta is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you this 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.
• You may store Follistim® AQ cartridge in a refrigerator or at room temperature for 3 months or until expiration date. If the cartridge has been pierced by a needle, you may store it up to 28 days. Keep the cartridge away from light.
• 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.
• Tell your doctor if you are breastfeeding, or if you have heart disease, lung or breathing problems, blood vessel problems, or a history of blood clots, stroke, ovary problems, or stomach surgery.
• This medicine may cause the following problems:
  • Ovarian hyperstimulation syndrome (OHSS), which can be life-threatening
  • 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.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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
• Change in how often or how much you urinate
• Chest pain, trouble breathing, coughing up blood
• Fast heartbeat or breathing
• Fever, chills, cough, sore throat, stuffy nose, body aches
• Numbness or weakness in your arm, leg, or on one side of your body, pain in your lower leg
• Rapid weight gain or swelling in your hips
• Severe menstrual-like cramps, bloating, passing gas, vaginal bleeding
• Severe nausea, vomiting, or stomach pain
• Sudden severe headache, problems with vision, speech, or walking

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

• Acne
• Breast pain
• Headache, back or joint pain
• Mild skin redness, dryness, rash, or itching
• Mild stomach pain or constipation
• Pain, swelling, itching, burning, or a lump under your skin where the shot is given

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