Drug Egrifta (Tesamorelin) [EMD Serono]
- Available as 1 mg in a single use vial for reconstitution
- Dose is 2 mg subcutaneous once daily
FDA approved indication
Tesamorelin (Egrifta™) is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat* in HIV-infected patients with lipodystrophy. Tesamorelin is not indicated for weight loss management. It has a weight neutral effect.
*Defined in clinical trials as 105 cm.
Criteria
- Patient has been diagnosed with HIV associated-visceral adipose tissue (VAT) lipodystrophy with a waist circumference of at least 105 cm AND
- A baseline IGF-1 is logged AND
- An accurate baseline waist circumference is logged AND
- The first PA is limited to 3 fills AND
- At 3 months of therapy, if the IGF-1 level is 3 SD, then no more refills will be added AND
- At 3 months of therapy, if waist circumference has not been reduced, then no more refills will be added AND
- If neither (e) or (f), then 9 fills may be added.
Exclusion criteria
- Active malignancy
- Pregnancy (pregnancy category X)
- Patients with a disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery, head irradiation or head trauma
- Known hypersensitivity to Tesamorelin or Mannitol
