To make using follitropin alfa as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of follitropin alfa. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes follitropin alfa can be given by injection at home. If you are using this medicine at home:

Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.

Wash yours hands with soap and water and use a clean work area to prepare your injection.

Make sure you clearly understand and carefully follow your doctor’s instructions on how to give yourself an injection, including using the proper needle and syringe.

Do not inject more or less of the medicine than your doctor ordered.

Remember to move the site of injection to different areas to prevent skin problems from developing.

Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of follitropin alfa. Follitropin alfa often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of follitropin alfa is given. Your doctor will give you this medicine or arrange for you to get this medicine at the right time.

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:

For treatment of female infertility:

Adults—75 international units (IU) injected under the skin once a day for approximately fourteen days. The dose may be increased at weekly intervals by 37.5 IU, up to a total dose of 300 IU once a day. Using follitropin alfa for longer than fourteen days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later. If abdominal pain occurs with the use of follitropin alfa, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.

For use with assisted reproductive technology (ART) procedures:

Adults—150 international units (IU) injected under the skin once a day for five days beginning on Day 2 or Day 3 of your menstrual cycle. After five days, your dose may be increased by 75 to 150 IU every three to five days, up to a total dose of 450 IU once a day, for up to five more days. Some patients may start treatment at a dose of 225 IU once a day. Using follitropin alfa for longer than ten days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later.

For treatment of male infertility

Adults— 150 international units (IU) injected under the skin three times a week in conjunction with 1000 USP Units of human chorionic gonadotropin (hCG) three times a week. Your dose may be increased up to 300 IU three times a week, and the treatment may last up to eighteen months.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Abnormal bleeding of genitals or uterus (unknown cause)—Use of follitropin alfa may make the diagnosis of this problem more difficult

Adrenal gland or thyroid disease (not controlled) or

Asthma or

Tumor, brain or

Tumor, sex hormone-dependent—Use of follitropin alfa may make these conditions worse

Ovarian cyst or enlarged ovaries—Use of follitropin alfa may increase the size of a cyst on an ovary or increase the size of enlarged ovaries

Primary testicular failure— Follitropin alfa will not work in patients who no longer are able to produce sperms

Primary ovarian failure—Follitropin alfa will not work in patients whose ovaries no longer develop eggs

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream. After you no longer receive follitropin alfa, your progress still must be checked for at least 2 weeks.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor’s directions carefully.

If abdominal pain occurs with use of follitropin alfa, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

This medicine may cause some people to become dizzy. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while you are using follitropin alfa and for 24 hours after you stop using it.

What should I watch for?

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.

Common and Rare Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

For patients treated for female infertility or patients pretreated with a gonadotropin-releasing hormone agonist (GnRHa) undergoing assisted reproduction technologies (ART)

Abdominal bloating

diarrhea

flu or cold-like symptoms, such as body aches or pain, coughing, fever, headache, loss of voice, runny nose, and unusual tiredness or weakness

nausea

passing of gas

vaginal bleeding between menstrual periods

For patients treated for female infertility

Acne

breast pain or tenderness

mood swings

Less common

For patients treated for female infertility or patients pretreated with GnRHa undergoing ART

Dizziness

painful menstrual periods

redness, pain, or swelling at injection site

sleepiness

vaginal bleeding unrelated to menstrual periods (heavy)

white vaginal discharge

For patients treated for female infertility

Fainting

light-headedness

migraine headache

nervousness

stomach discomfort

For patients treated pretreated with a GnRHa undergoing ART

Fast, racing heartbeat

itching of skin

loss of appetite

thirst (unusual)

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.