Gonal-f RFF (Follitropin Alfa Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Gonal-f RFF

Infertility »

What is infertility?

Infertility means not being able to get pregnant after one year of trying. Or, six months, if a woman is 35 or older. Women who can get pregnant but are unable to stay pregnant may also be infertile.

Pregnancy is the result of a process that has many steps. To get pregnant:

A woman must release an egg from one of her ovaries (ovulation).
The egg must go through a Fallopian tube toward the uterus (womb).
A man's sperm must join with (fertilize) the egg along the way.
The fertilized egg must attach to the inside of the uterus (implantation).

Infertility can happen if there are problems with any of these steps.

Is infertility a common problem?

Yes. About 10 percent of women (6.1 million) in the United States ages 15-44 have difficulty getting pregnant or staying pregnant, according to the Centers for Diseas...

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Gonal-f RFF

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Gonal-f® RFF
(follitropin alfa) For Subcutaneous Injection
*revised formulation female

DRUG DESCRIPTION

Gonal-f® RFF (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of follitropin alfa has been calibrated against the first International Standard for recombinant human follicle stimulating hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f® RFF (follitropin alfa injection) contains no luteinizing hormone (LH) activity. Based on available data derived from physico-chemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.

Gonal-f® RFF (follitropin alfa injection) is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution.

Each Gonal-f® RFF single-dose vial is filled with 82 IU (6 µg)follitropin alfa to deliver 75 IU (5.5 µg) follitropin alfa and contains 30 mg sucrose, 1.11 mg dibasic sodium phosphate dihydrate, 0.45 mg monobasic sodium phosphate monohydrate, 0.1 mg methionine, and 0.05 mg polysorbate 20. Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. Vials are reconstituted with Sterile Water for Injection, USP.

Under current storage conditions, Gonal-f® RFF may contain up to 10% of oxidized follitropin alfa.

Therapeutic Class: Infertility

What are the possible side effects of follicle stimulating hormone (Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
confusion, severe dizziness, severe headache; or

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What are the precautions when taking follitropin alfa injection (Gonal-f RFF)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other fertility problems (e.g., primary ovarian failure), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (e.g., breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome).

Before using this medication, tell your...

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Last reviewed on RxList: 7/26/2007
This monograph has been modified to include the generic and brand name in many instances.