Theratechnologies Inc. announced the availability of EGRIFTA WR? (tesamorelin) for injection for the reduction of excess abdominal fat in adult patients with HIV and lipodystrophy. The announcement follows the approval of EGRIFTA WR?
by the U.S. Food and Drug Administration (FDA) earlier this year. The new, improved formulation of tesamorelin for injection ? the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy ?
will gradually replace EGRIFTA SV®, the current formulation. Specialty pharmacies are now ordering EGRIFTA WR? to fill prescriptions for the new formulation.
EGRIFTA SV® will continue to be available during a transitional period as managed care plans increasingly provide coverage for EGRIFTA WR?. EGRIFTA WR? only needs weekly reconstitution and requires less than half the injection volume as EGRIFTA SV®, which is reconstituted daily.
The product is supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven daily injections. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. EGRIFTA WR?
can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution. The EGRIFTA WR? formulation is patent protected in the U.S. until 2033.
Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR? to the original F1 formulation of tesamorelin for injection (previously sold under the trade name EGRIFTA®). The most commonly reported adverse reactions of tesamorelin for injection include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.
Individuals with HIV and lipodystrophy who are currently using EGRIFTA SV® can enroll in the Thera Patient Support® program to help them transition to EGRIFTA WR? as insurance coverage becomes available. The program, which is offered free of charge, includes a dedicated team of Thera Nurse Navigators who are available to train enrolled patients on the use of EGRIFTA WR?.
EGRIFTA WR? (tesamorelin) for injection is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. EGRIFTA WR?
is a growth hormone- releasing factor (GHRF) analog that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR? has not been established.
Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR? is not indicated for weight loss management as it has a weight- neutral effect.
There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR?. Contraindications: Do not use EGRIFTA WR? if a patient: Has disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.
Has active cancer. Is allergic to tesamorelin or any of the ingredients in EGRIFTA WR?. Is pregnant or planning to become pregnant.
The most commonly reported adverse reactions of EGRIFTA WR? include: arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.
