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Disruption of the Hypothalamic-pituitary Axis
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™ .
EGRIFTA™ is contraindicated in patients with known hypersensitivity to tesamorelin and/or mannitol (an excipient) [see WARNINGS AND PRECAUTIONS].
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.
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