Generic Name and Formulations:
Tesamorelin 2mg/vial; pwd for SC inj after reconstitution; preservative-free.
Indications for EGRIFTA:
For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Give by SC inj. Inject into abdomen, rotate inj sites. 2mg once daily.
Disruption of hypothalmic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumors/surgery, head irradiation, or head trauma. Active malignancy. Pregnancy (Cat.X).
Not for use in weight loss management. History of treated and stable malignancies. Discontinue in critically ill patients. Monitor IGF-1 levels closely; consider discontinuing if IGF-1 levels persistently elevated (eg, >3 SDS). Increased risk of impaired glucose tolerance or diabetes; monitor for changes in glucose metabolism. Monitor for worsening retinopathy in diabetic patients. Nursing mothers: not recommended.
Caution with concomitant drugs metabolized by CYP450 (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine). May inhibit 11β-hydroxysteroid dehydrogenase type 1; may need to increase maintenance and stress doses of glucocorticoid if needed for replacement in hypoadrenalism.
Growth hormone releasing factor analogue.
Arthralgia, inj site erythema/pruritus, pain in extremity, peripheral edema, myalgia, carpal tunnel syndrome, glucose intolerance, hypersensitivity reactions.
Single-use vial—30 (w. diluent)