Follitropin Alfa Solution for injection

What is this medicine?

FOLLITROPIN ALFA (fol li TROE pin AL fa) helps stimulate the development of eggs within the ovary. It is used to treat women who have not been able to become pregnant because of problems with ovulation. This drug is also used in certain in vitro fertilization programs. For some men with infertility, this medicine helps to stimulate the production of sperm.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• abnormal or unusual vaginal bleeding
• asthma
• brain tumor or certain other kinds of cancer
• conditions affecting your adrenal gland or thyroid gland
• enlarged ovaries or ovarian cyst
• failure of the ovaries to produce eggs
• obstruction of the fallopian tubes
• testicular failure
• an unusual or allergic reaction to follitropin, other hormones, other medicines, foods, dyes, or preservatives
• pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional with experience in managing fertility disorders in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. If you do miss a dose, call your doctor or health care professional for advice.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chasteberry

This medicine may also interact with the following medications:

• black cohosh

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

It is important to keep all records required by your health care professional on body temperature and intercourse, and to carefully follow any directions for urine or blood testing or ultrasound exams. If you think you have become pregnant, contact your doctor or health care professional at once.

Certain fertility treatments increase your chances of having multiple babies, like twins or triplets.

If abdominal pain occurs while you are using this medicine, discontinue treatment and call your doctor or health care professional immediately. Do not use the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• any unusual symptoms or pain of penis or testes
• breast enlargement in males
• breathing problems
• chest pain
• fluid retention
• indigestion
• nausea, vomiting
• pain, swelling, warmth in the leg
• passing small amounts of urine
• rapid weight gain
• stomach area or pelvic pain or bloating

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• breast tenderness
• headache
• mood changes, such as irritability, restless feelings, or anger
• pain, irritation, or inflammation at site where injected
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store powder in the refrigerator or at room temperature between 2 and 25 degrees C (36 and 77 degrees F). Protect from light. After the powder is dissolved, the multi-dose vial and the pen may be stored in the refrigerator or at room temperature between 2 and 25 degrees C (36 and 77 degrees F) for up to 28 days. Single use vials should be used immediately after the powder is dissolved. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.