The newly approved F8 formulation of tesamorelin, a growth hormone–releasing factor analog, has been approved by the FDA for the reduction of excess visceral abdominal fat in adult patients with human immunodeficiency virus and lipodystrophy. The novel formulation, known as EGRIFTA WR, maintains a once-daily injection schedule, requires reconstitution only once weekly, and uses less than half the injection volume of the prior formulation. It is the only medication approved in the U.S. for this indication. However, it 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. Adverse events include arthralgia, injection-site reactions, pain in extremity, peripheral edema, and myalgia. Long-term cardiovascular safety has not been established, and clinicians are advised to evaluate the risk-benefit profile in patients who don't demonstrate a reduction in visceral adipose tissue.
Source: Therathechnologies