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EGRIFTA® (tesamorelin) kit 

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]

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DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

Initial U.S. Approval: 2010

DESCRIPTION
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. 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.

CLINICAL PHARMACOLOGY: top of page

MECHANISM OF ACTION
In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF.

Growth Hormone-Releasing Factor (GRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects. Some, but not all these effects, are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

INDICATIONS AND USAGE  top of page

EGRIFTA® is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.

CONTRAINDICATIONS top of page

-Disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery, head irradiation or head trauma.
-Active malignancy.
-Known hypersensitivity to tesamorelin and/or mannitol.
-Pregnancy

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS
Neoplasms
: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA® therapy.
Elevated IGF-1: Monitor regularly in all patients. Consider discontinuation in patients with persistent elevations.
Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome.
Glucose intolerance: May develop with EGRIFTA® use. Evaluate glucose status prior to and during therapy with EGRIFTA®.
Hypersensitivity reactions (e.g., rash, urticaria): Advise patients to seek immediate medical attention if suspected.
Injection site reactions: Advise patients to rotate sites.
Acute critical illness: Consider discontinuation.


DRUG INTERACTIONS
Cytochrome P450-metabolized drugs: Monitor carefully if used with EGRIFTA®.


USE IN SPECIFIC POPULATIONS
Nursing mothers: HIV-l infected mothers should not human milk-feed to avoid potential postnatal transmission of HIV-1.
Pediatric use: Safety and efficacy not established.

ADVERSE REACTIONS top of page

Most commonly reported adverse reactions (>5% and more frequent than placebo): Arthralgia, injection site erythema, injection site pruritis, pain in extremity, peripheral edema, and myalgia.

DOSAGE AND ADMINISTRATION  top of page

Recommended dose of EGRIFTA® is 2 mg injected subcutaneously once daily.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS
Each vial of EGRIFTA® contains 1 mg of tesamorelin. Another vial contains the reconstitution diluent, Sterile Water for Injection.


HOW SUPPLIED/STORAGE AND HANDLING
EGRIFTA® (tesamorelin for injection) is supplied as a sterile, white to off-white lyophilized powder. 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.

EGRIFTA® is available in a package comprised of two boxes. One box contains 60 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 20ºC to 25ºC (68°F to 77°F).

Syringes and needles are for single-use by a single patient and should never be shared between patients.

NDC 44087-2010-3


Fluid retention  - Advise patients that treatment with EGRIFTA® may cause symptoms consistent with fluid retention, including edema, arthralgia, and carpal tunnel syndrome. These reactions are either transient or resolve with discontinuation of treatment.

Hypersensitivity Reactions - Advise patients that hypersensitivity reactions (e.g., rash, urticaria) may occur during treatment with EGRIFTA®. Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA®.

Injection Site Reactions - Advise patients of possible injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising. To reduce the incidence of injection site reactions, advise patients to rotate the site of injection.

Counsel patients that they should never share an EGRIFTA® syringe with another person, even if the needle is changed. Sharing of syringes or needles between patients may pose a risk of transmission of infection.

How do I store EGRIFTA®?
  • EGRIFTA® has two boxes:
  • Store the Medication Box of EGRIFTA® vials in the refrigerator between 2°C and 8°C (36°F and 46°F).
  • Store the Injection Box of Sterile Water for Injection, syringes and needles at room temperature between 20ºC to 25ºC (68°F to 77°F).
  • Keep EGRIFTA® vials away from light.
  • Do not freeze.
  • After mixing, use EGRIFTA® right away and throw away any unused EGRIFTA®. Do not store mixed EGRIFTA®. Also, throw away the used bottle of Sterile Water for Injection
  • Do not use EGRIFTA® after the expiration date printed on the Medication Box and vial labels.

REFERENCE

Package Insert data: 
EGRIFTA® is a trademark of Theratechnologies Inc.
Distributed by: EMD Serono, Inc., Rockland, MA 02370, USA
Date: 11/2010
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