Follitropin alfa powder

Generic Name: follitropin alfa (FALL-lee-tro-pin)
Brand Name: Gonal-f

Follitropin alfa powder is used for:

Treating infertility in certain patients. It may also be used for other conditions as determined by your doctor.

Follitropin alfa powder is a human follicle-stimulating hormone. It is used to treat infertility in women by stimulating the ovaries to produce eggs.It is used to treat male infertility by increasing sperm count. Follitropin alfa powder is usually given with other medicines.

Do NOT use follitropin alfa powder if:

  • you are allergic to any ingredient in follitropin alfa powder
  • you are allergic to sucrose, sodium phosphate, or benzyl alcohol
  • you have uncontrolled thyroid or adrenal problems
  • you have pituitary tumor or other brain lesion or tumor
  • you have hormone-sensitive tumors
  • you have primary ovarian failure (eg, your ovaries do not make eggs)
  • you are pregnant or think you may be pregnant
  • you have cancer in your female organs (eg, ovaries, breast, uterus)
  • you have heavy or irregular bleeding from your uterus or vagina
  • you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

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

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Before using follitropin alfa powder:

Some medical conditions may interact with follitropin alfa powder. Tell your health care provider 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 or other substances
  • if you have urinary tract bleeding
  • if you have an adrenal gland or thyroid problem
  • if you have permanent damage to the testes
  • if you have swollen, enlarged, or painful ovaries
  • if you have blood-clotting problems or breathing problems (eg, asthma)

Some MEDICINES MAY INTERACT with follitropin alfa powder. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if follitropin alfa powder 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 alfa powder:

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

  • An extra patient leaflet is available with follitropin alfa powder. Talk to your pharmacist if you have questions about this information.
  • Follitropin alfa powder is usually administered as an injection at your doctor's office, hospital, or clinic. If you will be using follitropin alfa powder at home, a health care provider will teach you how to use it. Be sure you understand how to use follitropin alfa powder. 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 alfa powder if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not touch the needle or allow it to touch any surface.
  • The duration of treatment will be determined by your health care provider.
  • It is recommended that a couple using follitropin alfa powder has intercourse daily, starting on the day before the injection of follitropin alfa powder.
  • If you miss a dose of follitropin alfa powder, contact your doctor right away.

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

Important safety information:

  • Follitropin alfa powder may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use follitropin alfa powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Women will need to have a complete gynecological and hormone evaluation prior to starting therapy with follitropin alfa powder. Your partner should be evaluated for fertility problems.
  • Men will need to have a complete medical and hormone evaluation before starting therapy with follitropin alfa powder.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some women who use follitropin alfa powder. 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.
  • Follitropin alfa powder may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births.
  • Do not reuse needles, syringes, or other materials. Dispose of properly after use.
  • Lab tests, such as ultrasound or drawing an estradiol level, may be performed while you use follitropin alfa powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Follitropin alfa powder is not for use in the ELDERLY; safety and effectiveness in the elderly have not been confirmed.
  • Follitropin alfa powder should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use follitropin alfa powder if you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are or will be breast-feeding while you use follitropin alfa powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of follitropin alfa powder:

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 pain or growth; discomfort at the injection site; headache; sinus infection; stomach upset; 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; calf pain or tenderness; chest pain; confusion; fever; one-sided weakness; severe or persistent shortness of breath; severe pelvic or back pain; signs of OHSS (eg, decreased urination; diarrhea; severe or persistent stomach pain, upset or bloating; nausea; sudden unexplained weight gain; vomiting); slurred speech; unusual vaginal itching, discharge, or odor; vision changes.

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:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Proper storage of follitropin alfa powder:

Store follitropin alfa powder in the refrigerator or at room temperature between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. After follitropin alfa powder has been mixed, throw away any unused medicine after 28 days. Do not use follitropin alfa powder after the expiration date. Keep follitropin alfa powder out of the reach of children and away from pets.

General information:

  • If you have any questions about follitropin alfa powder, please talk with your doctor, pharmacist, or other health care provider.
  • Follitropin alfa powder 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 alfa powder 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 alfa powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to follitropin alfa powder. 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 alfa powder.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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