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Egrifta Generic Name & Formulations
Legal Class
Rx
General Description
Tesamorelin 1mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Growth hormone releasing factor analogue.
See Also
How Supplied
Egrifta—60 (vials w. diluent + supplies); Egrifta SV—30 (vials w. diluent + supplies)
Manufacturer
Generic Availability
NO
Egrifta Indications
Indications
For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Limitations of Use
Long-term cardiovascular benefit and safety have not been studied. Not for use in weight loss management. No data to support improved compliance with anti-retroviral therapies in HIV (+) patients.
Egrifta Dosage and Administration
Adult
Give by SC inj. Inject into abdomen, rotate inj sites. 2mg once daily.
Children
Not established.
Egrifta Contraindications
Contraindications
Disruption of hypothalmic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumors/surgery, head irradiation, or head trauma. Active malignancy. Pregnancy.
Egrifta Boxed Warnings
Not Applicable
Egrifta Warnings/Precautions
Warnings/Precautions
History of treated and stable malignancies. Fluid retention. 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.
Egrifta Pharmacokinetics
See Literature
Egrifta Interactions
Interactions
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.
Egrifta Adverse Reactions
Adverse Reactions
Arthralgia, inj site erythema/pruritus, extremity pain, peripheral edema, hyperglycemia, myalgia, carpal tunnel syndrome; glucose intolerance, hypersensitivity reactions.
Egrifta Clinical Trials
See Literature
Egrifta Note
Not Applicable
Egrifta Patient Counseling
See Literature
