Gonal-f RFF (Follitropin Alfa Injection) Drug Information: Overdosage and Contraindications

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May 27, 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...

Read the Infertility article »

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OVERDOSE

Aside from possible ovarian hyperstimulation and multiple gestations (see WARNINGS), there is no information on the consequences of acute overdosage with Gonal-f® RFF (follitropin alfa for injection).

CONTRAINDICATIONS

Gonal-f® RFF (follitropin alfa for injection) is contraindicated in women who exhibit:

Prior hypersensitivity to recombinant FSH preparations or one of their excipients.
High levels of FSH indicating primary gonadal failure.
Uncontrolled thyroid or adrenal dysfunction.
Sex hormone dependent tumors of the reproductive tract and accessory organs.
An organic intracranial lesion such as a pituitary tumor.
Abnormal uterine bleeding of undetermined origin (see "Selection of Patients").
Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients").
Pregnancy.