In the U.S.—

• Gonadotropin
• infertility therapy agent

Follitropin alfa (fol-li-TROE-pin AL-fa) is a hormone identical to follicle-stimulating hormone (FSH) produced by the pituitary gland. FSH helps to develop eggs in the ovaries.

Follitropin alfa is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation. Also, many women wanting to become pregnant will use this medicine while enrolled in a fertility program (assisted reproductive technology [ART]) that uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin alfa may be used with other medicines for these purposes.

Follitropin alfa is also used as a fertility medicine to help men with low sperm counts produce more sperms. Treatment with human chorionic gonadotropin should come before treatment with follitropin alfa. This pretreatment elevates the amount of testosterone to the correct level. Treatment with human chorionic gonadotropin should continue as long as follitropin alfa is being used.

Some patients may be treated with another hormone called gonadotropin-releasing hormone agonist (GnRHa) before starting treatment with follitropin alfa. GnRHa reduces the amount of FSH released from the pituitary gland. This is done so that the doctor can replace their FSH with follitropin alfa in the proper amounts each day to achieve fertility.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Parenteral
• For injection (U.S.)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to follitropin alfa or similar drugs. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Follitropin alfa is not needed or recommended for use during pregnancy. Since women using follitropin alfa may be more likely to have more than one child at a time, the problems of multiple births may be increased for women using this medicine. Also, this medicine has been shown to overstimulate the ovaries (ovarian hyperstimulation syndrome) for a longer time in some women who conceive than in women developing this syndrome who do not become pregnant. Signs of this syndrome include severe abdominal pain, nausea, rapid weight gain, and vomiting. Before you use this medicine, make sure your doctor knows if you are pregnant.

Breast-feeding—It is not known whether follitropin alfa passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Other medicines—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 doctor and pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• 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

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.

Dosing—

The dose of follitropin alfa 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 follitropin alfa. If your dose is different, do not change it unless your doctor tells you to do so.

• 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.

Missed dose—

If you miss a dose of this medicine, discuss with your doctor when you should receive your next dose. Do not double doses. If you have any questions about this, check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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 side 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, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor immediately if you notice any of the following side effects:

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

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