Rx Item-Egrifta Tesamorelin Acetate Pr 1mg W/Dil Pf Dshp

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EGRIFTA � safely and effectively. See full prescribing information for EGRIFTA �.
EGRIFTA � (tesamorelin for injection), for subcutaneous use
Initial U.S. Approval: 2010
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. (1)

Limitations of use:

Long-term cardiovascular benefit and safety of EGRIFTA� have not been studied. (1)
Not indicated for weight loss management (weight neutral effect). (1)
There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA�. (1)
DOSAGE AND ADMINISTRATION
Recommended dose of EGRIFTA� is 2 mg injected subcutaneously once daily. (2.1)
Reconstitute with diluent provided as recommended. (2.2)
Administer subcutaneously into abdominal skin, rotating sites. (2.3)
DOSAGE FORMS AND STRENGTHS
Each vial of EGRIFTA� contains 1 mg of tesamorelin (3). Another vial contains the reconstitution diluent, Sterile Water for Injection, USP. (3)
CONTRAINDICATIONS
Disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery, head irradiation or head trauma (4.1)
Active malignancy (4.2)
Known hypersensitivity to tesamorelin and/or mannitol (4.3)
Pregnancy (4.4)
WARNINGS AND PRECAUTIONS
Neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA� therapy. (5.1)
Elevated IGF-1: Monitor regularly in all patients. Consider discontinuation in patients with persistent elevations. (5.2)
Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome. (5.3)
Glucose intolerance: May develop with EGRIFTA� use. Evaluate glucose status prior to and during therapy with EGRIFTA�. (5.4)
Hypersensitivity reactions (e.g., rash, urticaria): Advise patients to seek immediate medical attention if suspected. (5.5)
Injection site reactions: Advise patients to rotate sites. (5.6)
Acute critical illness: Consider discontinuation. (5.7)
ADVERSE REACTIONS
Most commonly reported adverse reactions (>5% and more frequent than placebo): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact THERA patient supportTM toll free at 1-833-23-THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS
Cytochrome P450-metabolized drugs: Monitor carefully if used with EGRIFTA�. (7.1)
USE IN SPECIFIC POPULATIONS
Nursing mothers: HIV-1 infected mothers should not human milk-feed to avoid potential postnatal transmission of HIV-1. (8.3)
Pediatric use: Safety and efficacy not established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2018

M-EGRIFTA TESAMORELIN ACETATE
Item No.: Rx62064-0011-60 NDC No.62064-0011-60 62064-011-60 62064001160 62064001160 UPC No.:362064-011607 362064-011607 362064-011607 MPN No. 1160 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dis

EGRIFTA TESAMORELIN ACETATE PR
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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