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Limitations of Use
- Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of EGRIFTA™ treatment have not been studied and are not known, careful consideration should be given whether to continue EGRIFTA™ 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.
- EGRIFTA™ 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 EGRIFTA™.
DOSAGE AND ADMINISTRATION
General Dosing Information
The recommended dose of EGRIFTA™ 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.
EGRIFTA™ must be reconstituted with the diluent provided with the product.
Reconstitute the 2 mg vial of EGRIFTA™ 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 EGRIFTA™ are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the boxes containing EGRIFTA™ and diluent.
Administer EGRIFTA™ immediately following reconstitution and throw away any unused EGRIFTA™ solution. If not used immediately, the reconstituted EGRIFTA™ solution should be discarded. Do not freeze or refrigerate the reconstituted EGRIFTA™ solution.
Reconstituted EGRIFTA™ solution should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EGRIFTA™ must be injected only if the solution is clear, colorless and without particulate matter.
EGRIFTA™ 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.
Dosage Forms and Strengths
EGRIFTA™ (tesamorelin for injection) is supplied in a vial containing 2 mg of tesamorelin as a lyophilized powder. The diluent (Sterile Water for Injection, 10 mL) is provided in a separate vial.
EGRIFTA™ (tesamorelin for injection) is supplied as a sterile, white to off-white lyophilized powder. Each single-use vial of EGRIFTA™ contains 2 mg of tesamorelin as the free base ( 2.2 mg tesamorelin acetate, anhydrous) and the following inactive ingredient: 100 mg mannitol, USP.
EGRIFTA™ is available in a package comprised of two boxes. One box contains 30 vials of EGRIFTA™ and a second box contains 30 single-use 10 mL bottles of reconstitution diluent (Sterile Water for Injection, USP), disposable syringes, and needles sufficient for a 30 day supply.
After reconstitution with Sterile Water for Injection, the reconstituted solution concentration is 1 mg/mL and should be injected immediately.
EGRIFTA™ vials should be protected from light and be kept in the original box until time of use. Non-reconstituted EGRIFTA™ must be stored at refrigerated temperature, between 2°C and 8°C (36°F and 46°F). The reconstitution diluent (Sterile Water for Injection, USP), syringes and needles should be stored at controlled room temperature of 20°C to 25°C (68°F to 77°F).
Syringes and needles are for single-use by a single patient and should never
be shared between patients.
Distributed by: EMD Serono, Inc., Rockland, MA 02370, USA. Rev date: 11/2011
Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Egrifta Information
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