Follitropin, r-FSH injection (Follistim(TM))

What is this medication?

FOLLITROPIN BETA (fol li TROE pin BAY ta) 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 may also be used in women participating in an assisted reproductive technology program like in vitro fertilization.

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

COMMON BRAND NAME(S): Follistim, Follistim AQ

What should I tell my care team before I take this medication?

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
• an unusual or allergic reaction to follitropin beta, neomycin, streptomycin, other hormones, medicines, foods, dyes, or preservatives
• pregnant
• breast feeding

How should I use this medication?

This medicine is for injection under the skin. It is usually given by a health care professional 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 medication?

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 medication?

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

It is important to keep all records required by your care team 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 care team 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 medication, discontinue treatment and call your care team immediately. Do not use the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

What side effects may I notice from receiving this medication?

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
• 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 medication?

Keep out of the reach of children and pets.

Store in the refrigerator.

The medication may also be stored at room temperature, at approximately 25 degrees C (77 degrees F) for up to 3 months or until the expiration date, whichever occurs first. Do not freeze. If you are using the cartridges, once the rubber stopper has been pierced by a needle, the product can only be stored for a maximum of 28 days in the refrigerator or at room temperature between 2 and 25 degrees C (36 and 77 degrees F). Protect from light. Throw away any unused medication 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.