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Egrifta
Overview
What is Egrifta?
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 CHNOS • x CHO (x ≈ 7) and its molecular weight (free base) is 5135.9 Daltons. The structural formula of tesamorelin acetate is:
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.
What does Egrifta look like?
What are the available doses of Egrifta?
EGRIFTA (tesamorelin for injection) is supplied in a vial containing 1 mg of tesamorelin as a lyophilized powder. The diluent (Sterile Water for Injection, USP 10 mL) is provided in a separate bottle.
What should I talk to my health care provider before I take Egrifta?
How should I use Egrifta?
EGRIFTA (tesamorelin for injection) is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
Limitations of Use:
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.
What interacts with Egrifta?
Sorry No Records found
What are the warnings of Egrifta?
Sorry No Records found
What are the precautions of Egrifta?
Sorry No Records found
What are the side effects of Egrifta?
Sorry No records found
What should I look out for while using Egrifta?
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 ()
What might happen if I take too much Egrifta?
No data are available on overdosage.
How should I store and handle Egrifta?
Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60 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 1 mg each 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, USP 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 to 8°C (36°F to 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. NDC 62064-011-60
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
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 ()
The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.
Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.
Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.
EGRIFTA induces the release of endogenous growth hormone (GH), a known growth factor. Thus, patients with active malignancy should not be treated with EGRIFTA .
For patients with a history of non-malignant neoplasms, EGRIFTA therapy should be initiated after careful evaluation of the potential benefit of treatment. For patients with a history of treated and stable malignancies, EGRIFTA therapy should be initiated only after careful evaluation of the potential benefit of treatment relative to the risk of re-activation of the underlying malignancy.
In addition, the decision to start treatment with EGRIFTA should be considered carefully based on the increased background risk of malignancies in HIV-positive patients.
The most commonly reported adverse reactions are hypersensitivity (e.g., rash, urticaria) reactions due to the effect of GH (e.g., arthralgia, extremity pain, peripheral edema, hyperglycemia, carpal tunnel syndrome), injection site reactions (injection site erythema, pruritus, pain, urticaria, irritation, swelling, hemorrhage).
During the first 26 weeks of treatment (main phase), discontinuations as a result of adverse reactions occurred in 9.6% of patients receiving EGRIFTA and 6.8% of patients receiving placebo. Apart from patients with hypersensitivity reactions identified during the studies and who were discontinued per protocol (2.2%), the most common reasons for discontinuation of EGRIFTA treatment were adverse reactions due to the effect of GH (4.2%) and local injection site reactions (4.6%).
During the following 26 weeks of treatment (extension phase), discontinuations as a result of adverse events occurred in 2.4% of patients in the T-T group (patients treated with tesamorelin for Week 0-26 and with tesamorelin for Week 26-52) and 5.2% of patients in the T-P group (patients treated with tesamorelin for Week 0-26 and with placebo for Week 26-52).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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