In the U.S.—

• Gonadotropin
• infertility therapy agent

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

Follitropin beta 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 that uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin beta may be used with other medicines for these purposes.

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

Follitropin beta 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 beta, the following should be considered:

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

Pregnancy—Follitropin beta is not needed or recommended for use during pregnancy. Since women using follitropin beta 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 [OHSS]) for a longer time in some women who become pregnant 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 using this medicine, make sure your doctor knows if you are pregnant.

Breast-feeding—It is not known whether follitropin beta 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 beta may make the diagnosis of this problem more difficult

• Adrenal gland or thyroid disease (not controlled) or
• Asthma or
• Tumors, brain or
• Tumors, sex hormone-dependent—Use of follitropin beta may make these conditions worse

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

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

To make using follitropin beta 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 beta. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes follitropin beta 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 your hands with soap and water and use a good, 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 your last dose of follitropin beta. Follitropin beta often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of follitropin beta 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 beta 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 beta. 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 or into a muscle once a day for up to fourteen days. The dose may be increased at weekly intervals by 37.5 IU, up to a total dose of 300 IU a day. Tell your doctor when you receive your last dose of follitropin beta. If abdominal pain occurs with the use of follitropin beta, 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 or into a muscle once a day for four days beginning on Day 2 or Day 3 of your menstrual cycle. Then your dose may be increased by 75 to 150 IU up to a total daily dose of 600 IU. Some patients may start at 375 IU. Tell your doctor when you receive your last dose of follitropin beta.

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. Heat or moisture may cause the medicine to break down.
• 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, such as every other day, 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 beta, your progress still must be checked every other day for at least 2 weeks.

If your doctor has asked you to record your basal body temperature (BBT) 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 beta, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of 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 beta 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.

There is a rare chance that serious lung and blood problems can occur with use of follitropin beta. Discuss these possible effects with your doctor.

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:

• Less common
  • For patients treated for female infertility or patients pretreated with a gonadotropin-releasing hormone agonist (GnRHa) undergoing assisted reproduction technologies (ART)
  • Abdominal pain 
  
  
  • For patients pretreated with a GnRHa undergoing ART
    • Redness, pain, or swelling at injection site 
    
    

The following side effects have not been reported for follitropin beta, but may occur because they have been reported for similar medicines. Some of these side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Body aches or pain;  breast tenderness ;  chills;  difficulty in breathing;  dizziness;  dry skin;  fast, racing heart;  fever;  hair loss;  headache ;  hives;  nausea;  quick, shallow breathing;  skin rash ;  unusual tiredness 

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.