Follitropin alfa

What it is used for

GONAL-f is indicated for:

Side effects, and when to stop

The following serious adverse reactions are discussed elsewhere in the labeling:

• Hypersensitivity Reactions and Anaphylaxis
• Ovarian Hyperstimulation Syndrome
• Pulmonary and Vascular Complication
• Ovarian Torsion
• Abnormal Ovarian Enlargement
• Multi-fetal Gestation and Birth
• Embryofetal Toxicity
• Ectopic Pregnancy
• Spontaneous Abortion
• Ovarian Neoplasms

Who should not take it

GONAL-f is contraindicated in women and men who exhibit:

• Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis
• High levels of FSH indicating primary gonadal failure
• The presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)
• Sex hormone dependent tumors of the reproductive tract and accessory organs
• Tumors of pituitary gland or hypothalamus

GONAL-f is also contraindicated in women who exhibit:

• Abnormal uterine bleeding of undetermined origin
• Ovarian cyst or enlargement of undetermined origin

Storing it

Store vials refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F).

Store reconstituted solution refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F) and discard unused portion after 28 days. Protect from light.