Egrifta
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Egrifta
CONTRAINDICATIONS
Disruption of the Hypothalamic-pituitary Axis
EGRIFTA™ is contraindicated in patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.
Active Malignancy
EGRIFTA™ is contraindicated in patients with active malignancy (either newly diagnosed or recurrent). Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with EGRIFTA™ .
Hypersensitivity
EGRIFTA™ is contraindicated in patients with known hypersensitivity to tesamorelin and/or mannitol (an excipient) [see WARNINGS AND PRECAUTIONS].
Pregnancy
EGRIFTA™ is contraindicated in pregnant women. During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying this physiologic change of pregnancy with EGRIFTA™ offers no known benefit and could result in fetal harm. Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephalus in offspring at a dose approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). If pregnancy occurs, discontinue EGRIFTA™ therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use In Specific Populations].
Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Egrifta Information
Egrifta - User Reviews
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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