Ultima-Tesamorelin (Int)

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.

Administration

Reconstituted Tesamorelin solution should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Tesamorelin must be injected only if the solution is clear, colorless and without particulate matter.

Tesamorelin should be injected subcutaneously into the skin on the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.