February 8, 2016
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Gonal-F

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Gonal-F




Overdosage
Contraindications

OVERDOSE

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

CONTRAINDICATIONS

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

1. Prior hypersensitivity to recombinant FSH preparations or one of their excipients.

2. High levels of FSH indicating primary ovarian failure.

3. Uncontrolled thyroid or adrenal dysfunction.

4. An organic intracranial lesion such as a pituitary tumor.

5. Abnormal uterine bleeding of undetermined origin (see INDICATIONS AND USAGE: Selection of Patients).

6. Ovarian cyst or enlargement of undetermined origin (see INDICATIONS AND USAGE: Selection of Patients).

7. Sex hormone dependent tumors of the reproductive tract and accessory organs.

8. Pregnancy.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/8/2004

Overdosage
Contraindications

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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