EGRIFTA® (tesamorelin) kit
(description)
| Initial U.S. Approval: 2010
DESCRIPTION |
Clinical pharmacology
| 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
| EGRIFTA® is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. |
Contraindications
| -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
| 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 USE IN SPECIFIC POPULATIONS |
Adverse reactions
| 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. |
How supplied
| 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® 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®?
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Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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