Egrifta label

Egrifta

Egrifta Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

EGRIFTA® (tesamorelin for injection) is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy [see Clinical Studies (14)].

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®.
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History

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Other Information

EGRIFTA® contains tesamorelin (as the acetate salt), an analog of human growth hormone-releasing factor (GRF). The peptide precursor of tesamorelin acetate is produced synthetically and is comprised of the 44 amino acid sequence of human GRF. Tesamorelin acetate is made by attaching a hexenoyl moiety, a C6 chain with a double bond at position 3, to the tyrosine residue at the N-terminal part of the molecule. The molecular formula of tesamorelin acetate is C221H366N72O67S • x C2H4O2 (x ≈ 7) and its molecular weight (free base) is 5135.9 Daltons. The structural formula of tesamorelin acetate is:

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EGRIFTA® is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. After reconstitution with the supplied diluent (Sterile Water for Injection, USP), a solution of EGRIFTA® is clear and colorless. Each single-use vial of EGRIFTA® contains 1 mg of tesamorelin as the free base (1.1 mg tesamorelin acetate, anhydrous) and the following inactive ingredient: 50 mg mannitol, USP.

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Egrifta Manufacturers

  • Emd Serono, Inc.
    Egrifta | Emd Serono, Inc.
    No Recall

    Egrifta | Emd Serono, Inc.

    Egrifta | Emd Serono, Inc.
    2.1 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.

    2.2 Reconstitution Instructions

    Instructions for reconstituting EGRIFTA® are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the EGRIFTA® medication box and in the injection box.

    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. EGRIFTA® must be injected only if the solution is clear, colorless and without particulate matter.

  • Emd Serono, Inc.
    Egrifta | Emd Serono, Inc.
    No Recall

    Egrifta | Emd Serono, Inc.

    Egrifta | Emd Serono, Inc.
    2.1 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.

    2.2 Reconstitution Procedure

    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.

    2.3 Administration

    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.

  • Theratechnologies Inc.
    Egrifta | Cantrell Drug Company
    No Recall

    Egrifta | Cantrell Drug Company

    Egrifta | Cantrell Drug Company

    There is currently no dosage information available for this product. We apologize for any inconvenience.

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