tesamorelin

(redirected from Egrifta)

tesamorelin

(tess-a-moe-rel-in) ,

Egrifta

(trade name)

Classification

Therapeutic: none assigned
Pharmacologic: growth hormone releasing factor analogues
Pregnancy Category: X

Indications

Reduction of excess abdominal fat (lipodystrophy) seen in HIV-infected patients.

Action

Acts as an analog of human growth hormone-releasing factor (GRF, GHRH), resulting in endogenous production of growth hormone (GH), which has anabolic and lipolytic properties.

Therapeutic effects

Reduction of abdominal adipose tissue in HIV-infected patients.

Pharmacokinetics

Absorption: <4% absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 26–38 min.

Time/action profile (effect on visceral adipose tissue)

ROUTEONSETPEAKDURATION
Subcutwithin 3 mos10–12 mos3 mos†
†Following discontinuation.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to tesamorelin or mannitol;Any pathology that alters the hypothalamic-pituitary axis, including hypophysectomy, hypopituitarism, pituitary surgery/tumor, cranial irradiation/trauma; Obstetric: may cause fetal harm; Lactation: Breast feeding should be avoided by HIV-infected patients.
Use Cautiously in: Acute critical illness (may ↑ risk of serious complications; consider discontinuation);Pre-existing malignancy (disease should be inactive or treatment completed);Non-malignant neoplasms (carefully consider benefit);Persistently elevated Insulin-like Growth Factor (IGF-1; may require discontinuation);Diabetes mellitus (may cause glucose intolerance); Pediatric: Safe and effective use in children not established.

Adverse Reactions/Side Effects

Cardiovascular

  • peripheral edema

Endocrinologic

  • glucose intolerance

Local

  • erythema
  • hemorrhage
  • irritation
  • pain
  • pruritus

Musculoskeletal

  • arthralgia
  • carpal tunnel syndrome
  • extremity pain
  • myalgia

Miscellaneous

  • hypersensitivity reactions

Interactions

Drug-Drug interaction

May alter the clearance and actions of drugs known to be metabolized by the CYPP450 enzyme system including corticosteroids, androgens, estrogens and progestins (including hormonal contraceptives ), anticonvulsants, and cyclosporine, careful monitoring for efficacy and/or toxicity recommended.Inhibits the conversion of cortisone acetate and prednisone to active forms; patients on replacement therapy may need ↑ maintenance/stress doses.

Route/Dosage

Subcutaneous (Adults) 2 mg once daily.

Availability

Lyophilized powder for subcutaneous administration (requires reconstitution): 1 mg/vial

Nursing implications

Nursing assessment

  • Assess for fluid retention which manifests as ↑ tissue turgor and musculoskeletal discomfort (edema, arthralgia, extremity pain, carpal tunnel syndrome). May be transient or resolve with discontinuation of treatment.
  • Lab Test Considerations: Monitor serum IGF-I closely during therapy; tesamorelin stimulates growth hormone production and the effect on progression of malignancies is unknown. Consider discontinuing tesamorelin in patients with persistent elevations of IGF-I levels, especially if efficacy response is not strong.
    • May cause glucose intolerance and ↑ risk of developing diabetes. Monitor serum glucose prior to starting and periodically during therapy. Monitor diabetic patients closely for worsening of retinopathy.

Potential Nursing Diagnoses

Disturbed body image (Indications)

Implementation

  • Subcutaneous: Sterile Water for Injection 10 mL diluent is provided. Inject 2.2 mL of Sterile Water into tesamorelin, angled so that water goes down inside wall to prevent foaming. Roll vial gently between hands for 30 seconds to mix; do not shake. Change needle. Withdraw solution and inject into 2nd tesamorelin vial with solution against wall of vial. Mix between hands for 30 seconds. Withdraw all solution (2 mg/2.2 mL). Solution is clear and colorless; do not administer solution that is discolored or contains particulate matter. Use solution immediately upon reconstitution or discard; do not refrigerate or freeze. Change needle to 1/2 inch 27 gauge needle. Pinch skin and inject at right angle into abdomen below navel; rotate sites. Remove hand from pinched area and inject slowly. Do not inject into scar, bruises, or the navel. Prior to reconstitution, vials must be refrigerated and protected from light.

Patient/Family Teaching

  • Instruct patient on correct technique for administration of tesamorelin. Caution patient never to share needles with others.
  • Inform patient that tesamorelin may cause symptoms of fluid retention (edema, arthralgia, carpal tunnel syndrome); usually transient or resolve with discontinuation of therapy.
  • Advise patient to discontinue tesamorelin and notify health care professional promptly if signs and symptoms of hypersensitivity (rash, urticaria, hives, swelling of face or throat, shortness of breath, fast heartbeat, fainting) occur.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
References in periodicals archive ?
TO) (NasdaqGM :THER) revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) to revise the storage conditions of EGRIFTA (tesamorelin for injection).
Following revision of the EGRIFTA (tesamorelin for injection), the storage conditions for the 2 mg vial is up to 12 weeks at or below 25[degree sign]C after dispensing to the patient, said the company.
According to Theratechnologies Inc, tesamorelin is the first and only therapy approved in the US for treating excess abdominal fat in HIV-infected patients with lipodystrophy where it is commercialised under the tradename EGRIFTA.
That same month, MS got FDA approval for Egrifta, an injectable
The FDA announced it approved Egrifta for lipodystrophy, which causes excess fat in the liver, stomach and other abdominal organs.
If approved, the company plans to market the drug as Egrifta.
According to the company , its US Food and Drug Administration approved tesamorelin is marketed in the US as EGRIFTA and the product is used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
In the US, tesamorelin is marketed under the trade name EGRIFTA.
TO)(NASDAQ:THER) today announced that the Therapeutic Products Directorate of Health Canada has accepted to review its New Drug Submission (NDS) for EGRIFTA .
The MAA was submitted under the name "TESAMORELIN FERRER" and the submission is based on the positive results from two Phase 3 clinical trials as well as a marketing approval by the US Food and Drug Administration in the US under the trade name EGRIFTA.
Such high growth can be attributed to the approval of the first FDA approved pharmacologic drug, Egrifta, in the otherwise dormant HIV associated lipodystrophy therapeutics market in November 2010.
Nov 11, 2010: Theratechnologies Receives FDA Approval For EGRIFTA For Reduction Of Excess Abdominal Fat In HIV-Infected Patients With Lipodystrophy