Follitropin beta

Generic Name: follitropin beta (FOL-i-TROE-pin BAY-ta)
Brand Name: Follistim AQ

Follitropin beta is used for:

Increasing the chance of ovulation and/or pregnancy in certain women. It is also used to increase sperm production in certain men. It may also be used for other conditions as determined by your doctor.

Follitropin beta is a gonadotropin (human follicle-stimulating hormone, hFSH). It works in women by helping the ovaries to produce and release mature eggs. It works in men by helping the testicles to produce sperm.

Do NOT use follitropin beta if:

  • you are allergic to any ingredient in follitropin beta, to other hFSH products (eg, follitropin alfa), or to streptomycin or neomycin
  • you are pregnant
  • you have heavy or irregular vaginal bleeding of unknown cause
  • you have ovarian cysts or enlargement of the ovaries not due to polycystic ovarian syndrome (PCOS)
  • your testicles are unable to produce sperm
  • your ovaries are unable to produce eggs
  • you have uncontrolled thyroid, pituitary, or adrenal gland problems
  • you have tumors of the breast, ovaries, uterus, testicles, hypothalamus, or pituitary gland

Contact your doctor or health care provider right away if any of these apply to you.

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Before using follitropin beta:

Some medical conditions may interact with follitropin beta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a personal or family history of blood clots, you have an increased risk for blood clots, or you are very overweight
  • if you have had stomach or abdominal surgery, growths or cysts in your ovary, a twisting of the ovary (ovarian torsion), or you have fallopian tube problems or polycystic ovary disease

Some MEDICINES MAY INTERACT with follitropin beta. However, no specific interactions with follitropin beta are known at this time.

Ask your health care provider if follitropin beta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use follitropin beta:

Use follitropin beta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with follitropin beta. Talk to your pharmacist if you have questions about this information.
  • Follitropin beta is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using follitropin beta at home, a health care provider will teach you how to use it. Be sure you understand how to use follitropin beta. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use follitropin beta if it contains particles, is cloudy or discolored, or if the vial or cartridge is cracked or damaged.
  • After giving the injection, cover the injection site with a small bandage, if necessary.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of follitropin beta, contact your doctor right away.

Ask your health care provider any questions you may have about how to use follitropin beta.

Important safety information:

  • Women will need to have a complete gynecological and hormone examination before starting follitropin beta. Men will need to have a complete medical and hormone examination before starting follitropin beta. Your partner should be evaluated for fertility potential before you start therapy. Discuss any questions or concerns with your doctor.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some women who use follitropin beta. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden, unexplained weight gain; shortness of breath; or decreased urination.
  • Cases of serious blood clots have been reported following gonadotropin treatment in women. Seek immediate medical attention if you experience calf or leg pain, redness, swelling, or tenderness; chest pain; coughing up blood; shortness of breath; symptoms of a heart attack (eg, chest, jaw, or left arm pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting); or symptoms of a stroke (eg, one-sided weakness, slurred speech, confusion). Discuss any questions or concerns with your doctor.
  • Follitropin beta may increase the risk of twisting of the ovaries (ovarian torsion) in women with certain conditions such as OHSS, pregnancy, and previous stomach or abdominal surgery. This could cause blood flow to the ovary to be cut off. Discuss any questions or concerns with your doctor.
  • The risk of ectopic pregnancy (pregnancy outside the uterus) may be increased in some women, especially those with damaged fallopian tubes. Talk with your doctor if you have questions or concerns about your risk for ectopic pregnancy.
  • The use of follitropin beta in women may result in multiple births (eg, twins). Discuss this possibility with your doctor.
  • Do not switch brands or types of follitropin beta or methods of administration without first talking to your doctor. Doing so may require an adjustment of the dose. Discuss any questions or concerns with your doctor or pharmacist.
  • Lab tests, including estradiol blood levels and ultrasounds, testosterone blood levels, and semen analysis, may be performed while you use follitropin beta. These tests may be used to monitor your condition or to check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Do not use follitropin beta if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if follitropin beta is found in breast milk. Do not breast-feed while taking follitropin beta.

Possible side effects of follitropin beta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; breast enlargement or tenderness; headache; mild stomach pain; minor pain, bruising, swelling, or redness at the injection site;nausea; stomach discomfort; tiredness

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; persistent pain, bruising, swelling, or redness at the injection site; severe pelvic pain; stomach pain or bloating

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include decreased urination; diarrhea; nausea; severe stomach pain or swelling; shortness of breath; sudden, unexplained weight gain; vomiting.

Proper storage of follitropin beta:

Store follitropin beta between 34 and 46 degrees F (2 and 8 degrees C) until the expiration date. It may also be stored at 77 degrees F (25 degrees C) for 3 months or until the expiration date, whichever occurs first. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep follitropin beta out of the reach of children and away from pets.

CARTRIDGES: 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 between 36 and 77 degrees F (2 and 25 degrees C).

VIALS: Discard any unused medicine remaining in the vial after use.

General information:

  • If you have any questions about follitropin beta, please talk with your doctor, pharmacist, or other health care provider.
  • Follitropin beta is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take follitropin beta or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about follitropin beta. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to follitropin beta. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using follitropin beta.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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