Theratechnologies Inc's Egrifta

The FDA approved Egrifta (tesamorelin) to treat lipodystrophy in HIV-infected patients.

Theratechnologies Inc’s Egrifta

Egrifta (tesamorelin) from Theratechnologies Inc was approved by the FDA on November 10, 2010, to treat lipodystrophy in patients also diagnosed with HIV.¹

Lipodystrophy is a condition associated with some antiretroviral medications commonly prescribed to HIV patients.¹ Lipodystrophy causes excessive adipose tissue to develop in certain areas of the body.¹

Pharmacology and Pharmacokinetics

Egrifta, an analog of growth hormone— releasing factor, binds to and stimulates growth hormone–releasing factor receptors. ² It does this with a potency comparable to that of endogenous growth hormone—releasing factor.² In the same way that endogenous growth hormonereleasing factor acts on the pituitary cells to synthesize and release growth hormone, Egrifta stimulates the secretion of growth hormone.²

Dosing and Administration

Egrifta is prescribed as a once-daily subcutaneous (sc) injection of 2 mg.¹ The injection should be given in the abdomen daily and injection sites should be rotated to lessen injection site reactions.² It is also important not to inject Egrifta in the navel or areas that are compromised by scar tissue or bruising.²

Clinical Trials

There were 2 multicenter studies done with HIV-infected patients who had lipodystrophy for a 26-week intervention phase followed by a 26-week safety extension. A total of 806 HIV patients treated with antiretroviral therapy with excess abdominal fat were randomized to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc once daily.³

At week 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P group, n = 135) for an additional 26 weeks, and patients on placebo were switched to tesamorelin (P-T group, n = 197).³

Visceral adipose tissue (VAT) was measured by computed tomography scan at the end of week 26 in the tesamorelin-treated patients; the VAT decreased significantly (—24 ± 41 cm2 vs 2 ± 35 cm2, tesamorelin vs placebo, P <0.001; treatment effect, –15.4%). At week 52, decreases in VAT [–35 ± 50 cm2 (–17.5 ± 23.3%)] and other measures, such as waist circumference, cholesterol, triglycerides, and nondensity lipoproteins (all P <0.001 vs original baseline), were maintained in the T-T group.³

Precautions and Contraindications

Common side effects of patients taking Egrifta include injection site reactions, nausea, vomiting, fluid retention, and stomach, muscle, and joint pain.² A decline in control over blood sugar has been noted in some patients while taking Egrifta.² The safety and efficacy of Egrifta in pediatric and geriatric populations has not been confirmed.² The safe and efficacious use of Egrifta in patients with limited renal and hepatic function has not been validated.² Egrifta should not be given to women who are pregnant or nursing.²

Egrifta should not be used in patients with pituitary gland tumors or other related health conditions, or those who have recently undergone pituitary gland surgery.² Egrifta is contraindicated in patients with any active malignancy, and treatment should be thoroughly evaluated in patients with history of cancer.² Patients with a history of hypersensitivity reactions to either tesamorelin or mannitol should not be treated with Egrifta.²

Patients with elevated levels of insulin-like growth factor I (IGF-I) should be closely monitored. If elevated levels of IGF-I persist, treatment with Egrifta should be discontinued. ² As glucose intolerance may develop, patients should be monitored for variations in their glucose metabolism and the use of Egrifta in those with diabetes should be evaluated and closely monitored.²

Cocomittant administration of Egrifta and drugs metabolized through the cytochrome P450 pathway may result in changed clearance rates of these drugs and should be monitored.² PT

Caryn Belisle, RPh, Alka Patel, PharmD, and Amanda Slowinski, PharmD Candidate Egrifta, an analog of growth hormone— releasing factor, binds to and stimulates growth hormone– releasing factor receptors. Both Ms. Belisle and Dr. Patel are pharmacists at Brigham & Women’s Hospital, Boston, Massachusetts. Ms. Slowinski is a third-year pharmacy student at Northeastern University, Boston, Massachusetts.