tesamorelin

FDA Drug Profile — EGRIFTA WR, EGRIFTA SV

Drug Details

Generic Name
tesamorelin
Brand Names
EGRIFTA WR, EGRIFTA SV
Application Number
BLA022505
Sponsor
Theratechnologies Inc.
NDC Codes
2
Dosage Forms
KIT
Routes
SUBCUTANEOUS
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. 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. EGRIFTA WR is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. ( 1 ) Limitations of use: Long-term cardiovascular safety of EGRIFTA WR has not been established. ( 1 ) Not indicated for weight loss management. ( 1 ) There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR. ( 1 )