Tesamorelin (Tesamorelin) is made with growth hormone-releasing factor
(GRF).
Tesamorelin is used to reduce excess fat around
the stomach that is caused by taking certain HIV medications. This condition is
also called lipodystrophy (LYE-poe-DIS-troe-fee).
Tesamorelin is not a weight-loss medication and
should not be used to treat obesity.
Tesamorelin (Tesamorelin for injection) is
indicated for the reduction of excess abdominal fat in HIV-infected patients
with lipodystrophy.
Limitations of Use:
Since the long-term cardiovascular safety and
potential long-term cardiovascular benefit of Tesamorelin treatment have not
been studied and are not known, careful consideration should be given whether
to continue Tesamorelin treatment in patients who do not show a clear efficacy
response as judged by the degree of reduction in visceral adipose tissue measured
by waist circumference or CT scan. Tesamorelin is not indicated for weight loss
management (weight neutral effect). There are no data to support improved compliance
with anti-retroviral therapies in HIV-positive patients taking Tesamorelin.
General Dosing Information
The recommended dose of Tesamorelin is 2 mg
injected subcutaneously once a day.
The recommended injection site is the abdomen.
Injection sites should be rotated to different areas of the abdomen. Do not
inject into scar tissue, bruises or the navel.
Reconstitution Procedure
Tesamorelin must be reconstituted with the diluent
provided with the product.
Reconstitute the 2 mg vial of Tesamorelin with 2.1
mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do
not shake.
Detailed instructions for reconstituting
Tesamorelin are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the
boxes containing Tesamorelin and diluent.
Administer Tesamorelin immediately following
reconstitution and throw away any unused Tesamorelin solution. If not used
immediately, the reconstituted Tesamorelin solution should be discarded. Do not
freeze or refrigerate the reconstituted Tesamorelin solution.
