The U.S. Food and Drug Administration has approved a new formulation of tesamorelin for injection (EGRIFTA WR), for the reduction of excess visceral abdominal fat in adult patients with human immunodeficiency virus and lipodystrophy, according to an announcement from Theratechnologies Inc. The newly approved F8 formulation is set to replace the currently marketed F4 formulation (EGRIFTA SV).
The novel tesamorelin formulation is the only medication approved in the United States for this indication, maintains a once-daily injection schedule, but requires reconstitution only once weekly and uses less than half the injection volume of the prior formulation, according to a press release from Therathechnologies. Pharmacokinetic data demonstrated bioequivalence to the original F1 formulation of tesamorelin. Each vial contains 11.6 mg of tesamorelin, yielding seven doses per vial. The recommended daily subcutaneous dose is 1.28 mg (0.16 mL of reconstituted solution). The product may be stored at 20° C to 25° C (68° F to 77° F) prior to and following reconstitution.
Tesamorelin is a growth hormone–releasing factor analog that stimulates endogenous growth hormone production. Common adverse events reported with the novel tesamorelin formulation included arthralgia, injection-site reactions, pain in extremity, peripheral edema, and myalgia. The product is contraindicated among patients with disruption of the hypothalamic-pituitary axis, active malignancy, and hypersensitivity to tesamorelin or its components as well as those who are pregnant or planning pregnancy.
The F8 formulation was not indicated for weight loss management and has a weight-neutral profile. There are currently no data supporting improved adherence to antiretroviral therapy with tesamorelin use, and long-term cardiovascular safety has not been established. Clinicians were advised to evaluate the risk-benefit profile in patients who don't demonstrate a reduction in visceral adipose tissue.
Manufacturing of the novel tesamorelin formulation will occur at a U.S.-based contract facility. The formulation is patent protected in the United States until 2033. Adverse events should be reported to Theratechnologies or to the U.S. Food and Drug Administration's (FDA) MedWatch program. Full prescribing information is available through Theratechnologies and the FDA.
