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Follitropin, r-FSH injection (Follistim™)

What is follitropin, r-FSH injection?

FOLLITROPIN BETA (Follistim® AQ) is a hormone that is identical to follicle stimulating hormone (FSH), a natural hormone produced in the body. FSH helps to develop eggs in the ovaries. Follitropin is used to treat women who have not been able to become pregnant because of problems with ovulation. It is also used in fertility programs to help women become pregnant. Generic follitropin injections are not available.

What should my health care professional know before I receive follitropin, r-FSH injection?

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

  • abnormal or unusual vaginal bleeding

  • conditions affecting your adrenal gland or thyroid gland

  • asthma

  • brain tumor or certain other kinds of cancer

  • enlarged ovaries or ovarian cyst

  • failure of the ovaries to produce eggs

  • an unusual or allergic reaction to follitropin beta, other hormones, medicines, foods, dyes, or preservatives

  • pregnant

  • breast feeding

How should I use this medicine?

Follistim® AQ is for injection under the skin. It is usually given under the direct supervision of a prescriber or health care professional with experience in managing fertility disorders. Sometimes this medicine can be given at home. You will be taught how to use the Follistim Pen™ and how to refill the device with the Follistim® AQ cartridges. You should 1) understand the proper method of safely preparing the medicine, 2) wash your hands and use a clean work area to prepare your injection, 3) carefully follow your prescriber's instructions on how to give yourself an injection, including use of the needle and syringe, 4) do not inject more or less of the medicine than your prescriber ordered, 5) rotate the site of injection to different areas to prevent skin problems, and 6) safely throw away needles, syringes, bottles, and unused medicine after the injection.

Tell your prescriber or health care professional when you use the last dose of Follistim® AQ. It is often required that another hormone called human chorionic gonadotropin (hCG) be given after the last dose of Follistim® AQ therapy. Your prescriber or health care professional will give you this medicine or arrange for you to get this medicine at the right time.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

Try not to miss a dose. If you are unable to keep an appointment, call your prescriber or health care professional to reschedule. If you are injecting the drug yourself and you miss a dose, discuss with your prescriber or health care professional when you should give your next dose. Do not double doses.

What drug(s) may interact with follitropin, r-FSH injection?

  • herbal or dietary supplements, like blue cohosh, black cohosh, or chasteberry

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking follitropin, r-FSH injection?

You must be closely monitored by your prescriber or health care professional. Contact your prescriber or health care professional at once if you think you are pregnant. After you no longer receive follitropin beta, your progress still must be checked for at least 2 weeks.

If you are receiving follitropin beta to help you get pregnant, it is important to keep all records required by your prescriber or health care professional such as daily basal body temperature (BBTs) and sexual intercourse. 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.

If abdominal pain occurs while using follitropin beta, discontinue treatment and call your prescriber or health care professional immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

You may get dizzy. If this occurs, do not drive, operate heavy machinery, or do anything else that could be dangerous while using follitropin beta and for 24 hours after you stop using it.

What side effects may I notice from receiving follitropin, r-FSH injection?

Stop taking this medicine and call your prescriber or health care professional immediately if any of the following side effects occur:

  • nausea or vomiting

  • severe abdominal pain

  • swelling and rapid weight gain

Side effects that you should report to your prescriber or health care professional as soon as possible:

More common:

  • abdominal bloating

  • acne

  • breast pain

  • 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.

  • gas

  • mood swings

  • vaginal bleeding between menstrual periods

Less common:

  • dizziness

  • drowsiness

  • fainting

  • fast heartbeat

  • itching of skin

  • lightheadedness

  • migraine headache

  • nervousness

  • painful menstrual periods

  • redness, pain, or swelling at the injection site

  • stomach discomfort

  • unusual thirst

  • vaginal bleeding (heavy) unrelated to menstrual periods

  • white vaginal discharge

After you stop using this medicine, your body may need time to adjust. How long this takes depends on the amount of medicine you were using and the length of time you used it. During this time, check with your prescriber or health care professional immediately if you notice any of the following side effects:

  • nausea or vomiting

  • severe abdominal pain

  • swelling and rapid weight gain

Where can I keep my medicine?

Keep out of the reach of children.

Store unopened Follistim® AQ cartridges in a refrigerator, between 2—8 degrees C (36—46 degrees F), until the expiration date. Alternatively, store at room temperature, at approximately 25 degrees C (77 degrees F) for 3 months or until the expiration date, whichever occurs first. Do not freeze. Once the rubber stopper of the cartridge 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. Protect from light.

Follitropin, r-FSH injection (Gonal-F®)

What is follitropin alfa injection?

FOLLITROPIN ALFA (Gonal-F®) is a hormone that is identical to follicle stimulating hormone (FSH), a natural hormone produced in the body of both men and women. In women, FSH helps stimulate the development of eggs within the ovary. Gonal-F® is used to treat women who have not been able to become pregnant because of problems with ovulation; this drug is used with other fertility drugs. This drug is also used in certain in vitro fertilization ('test tube baby') programs. For some men with infertility, Gonal-F® helps to stimulate the production of sperm. Generic follitropin alfa injections are not available.

What should my health care professional know before I receive follitropin alfa?

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

  • abnormal or unusual uterine or vaginal bleeding

  • conditions affecting your adrenal gland or thyroid gland

  • asthma

  • brain tumor or certain other kinds of cancer

  • enlarged ovaries or ovarian cyst

  • failure of the ovaries to produce eggs

  • testicular failure

  • an unusual or allergic reaction to follitropin alfa, other hormones, medicines, foods, dyes, or preservatives

  • pregnant

  • breast-feeding

How should I use this medicine?

Gonal-F® is for injection under the skin. It is usually given under the direct supervision of a health care professional with experience in managing fertility disorders, in a place where appropriate laboratory testing is available. Sometimes this medicine can be given by at home. If you are to use this medicine at home, you will be taught how to prepare a Gonal-F® injection or how to use the Gonal-F™ RFF Pen. You should 1) understand the proper method of safely preparing the medicine, 2) wash your hands and use a clean work area to prepare your injection, 3) carefully follow your prescriber's instructions on how to give yourself an injection, including use of the needle and syringe, 4) do not inject more or less of the medicine than your prescriber ordered, 5) rotate the site of injection to different areas to prevent skin problems, and 6) safely throw away needles, syringes, bottles, and unused medicine after the injection.

For men: Depending on how the follitropin will be used, the length of treatment, and your comfort, your health care professional may teach you how to give your own injections. Otherwise the injections will be given by a trained health care professional in the prescriber's office, clinic, or by home health care.

For women receiving infertility treatments: Your fertility specialist will explain the needed procedures. Tell your prescriber or health care professional when you use the last dose of Gonal-F®. It is often required that another hormone called human chorionic gonadotropin (hCG) be given after the last dose of Gonal-F® therapy. Your prescriber or health care professional will give you this medicine or will teach you how to give your own injections.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

For men: Try not to miss a dose. If you are giving your own injections, and miss a dose, take it as soon as you remember. If you forget until the next day, skip the missed dose and continue with your schedule. Do not use double or extra doses. Call your prescriber if you have any questions.

For women receiving infertility treatments: It is important not to miss a dose, as the success of your fertility treatments depends on proper use of this medication, and fertility treatments are expensive. Call your prescriber or health care professional if you are unable to keep an appointment. If you are giving your own injections, do not use double or extra doses. Call your prescriber if you have any questions.

What drug(s) may interact with follitropin alfa?

  • herbal or dietary supplements, like blue cohosh, black cohosh, or chasteberry

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking follitropin alfa?

You may get dizzy. If this occurs, do not drive, operate heavy machinery, or do other activities requiring alertness while using follitropin alfa.

For women on follitropin alfa for fertility treatments:

Your prescriber or health care professional must closely monitor 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 prescriber at once.

Certain fertility treatments increase your chances of having multiple babies, like twins or triplets.

Drinking alcoholic beverages or smoking tobacco may decrease some person's chances of becoming pregnant. Talk with your health care professional about not drinking alcohol and decreasing tobacco use during your fertility treatments.

If abdominal pain occurs while using follitropin alfa, discontinue treatment and call your prescriber or health care professional immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

For males on follitropin alfa to treat infertility problems:

Your prescriber or health care professional must closely monitor you. Notify your prescriber if you notice any unusual effects from this medication.

What side effects may I notice from receiving follitropin alfa?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Any symptoms of rare allergic reactions (men or women):

  • difficulty breathing or shortness of breath

  • itching

  • skin rash or hives

  • swelling of the areas of the mouth or throat

For men:

  • acne (pimples)

  • any unusual symptoms or pain of penis or testes

  • breast enlargement

For women on fertility treatments:

  • chest pain, sudden shortness of breath

  • difficulty breathing

  • fluid retention

  • indigestion

  • nausea, vomiting

  • passing small amounts of urine

  • stomach area or pelvic pain or bloating

  • swelling of any area of the body

  • rapid weight gain

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

  • breast tenderness

  • headache

  • mood changes, such as irritability, restless feelings, or anger

  • pain, irritation or inflammation at the injection site

  • tiredness

After you stop using this medicine, your body may need time to adjust. How long this takes depends on the amount of medicine you were using and the length of time you used it. During this time, check with your prescriber or health care professional immediately if you notice any of the following side effects:

  • nausea or vomiting

  • severe abdominal pain

  • swelling and rapid weight gain

Where can I keep my medicine?

Keep out of the reach of children.

Store powder in the refrigerator or at room temperature. Protect from light. After the powder is dissolved, use immediately and throw away any unused medicine left in the vial. Discard medicine after the expiration date.

Publication Source: U.S. FDA-approved Package Insert
Date Last Modified: 9/18/2006