When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to follitropin beta, streptomycin, neomycin, or other forms of follicle-stimulating hormone (FSH). You should not use this medicine if you have adrenal gland problems, pituitary gland problems, thyroid gland problems, or a tumor in the brain (including the hypothalamus area or pituitary gland), breast, ovary, testis, or uterus. You should not use this medicine if you have cysts in the ovaries, enlarged ovaries, unusual vaginal bleeding, or high levels of FSH in the blood. You should not use this medicine if you are pregnant.

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) 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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. 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.

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.
• Make sure your doctor knows if you are breastfeeding, or if you have lung or breathing problems, blood vessel problems, or a history of blood clots, problems with your ovaries (such as twisting of an ovary), or stomach surgery.
• For women, this medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Stop using this medicine and call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble with breathing.
• 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 check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests will be needed to make sure that the medicine is working properly.

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, shortness of breath, or coughing up blood.
• Decrease in how often or how much you urinate.
• Fast heartbeat or breathing.
• Fever, chills, cough, sore throat, stuffy nose, or body aches.
• Numbness or weakness in your arm, leg, or on one side of your body.
• Pain, swelling, itching, burning, or a lump under your skin where the shot is given.
• Pain in your lower leg (calf).
• Rapid weight gain or swelling in your hips.
• Severe menstrual-like cramps, stomach pain, nausea, vomiting or diarrhea.
• 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, or pain in your back or joints.
• Mild skin redness, dryness, rash, or itching.
• Mild stomach pain, or constipation.

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