Follitropin Alfa Solution for injection

FOLLITROPIN ALFA (fol li TROE pin AL fa) treats irregular or absent ovulation in people trying to get pregnant. It works by helping the body release an egg (ovulation), which increases the chance of pregnancy. It may also be used to treat low sperm count. It works by helping the body make more sperm. It is often used as part of a fertility treatment program.

This medication is injected under the skin. It is usually given by a care team in a hospital or clinic setting.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

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 care team to get one.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Ovarian hyperstimulation syndrome—stomach or pelvic pain, bloating, nausea, vomiting, diarrhea, weight gain
• Trouble breathing

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

• Acne
• Breast pain or tenderness
• Fatigue
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Stomach pain

Keep out of the reach of children and pets.

Store powder in the refrigerator or at room temperature between 20 and 25 degrees C (68 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 for up to 28 days. Single use vials should be used immediately after the powder is dissolved. Get rid of any unused medication after the expiration date.

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

• Abnormal or unusual vaginal bleeding
• Asthma
• Cancer
• Conditions affecting your adrenal or thyroid gland
• Enlarged ovaries or ovarian cyst
• Fallopian tube blockage
• Hypogonadism
• Ovarian insufficiency
• An unusual or allergic reaction to follitropin alpha, other hormones, other medications, foods, dyes, or preservatives
• Pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Chasteberry

This medication may also interact with the following:

• Black cohosh

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

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.