Rx Item-Trogarzo- Ibalizumab Injection Solution 200Mg/1.33Ml

For: HIV Infection Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection in heavily treatment-experienced adults. These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO� (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: [2018] INDICATIONS AND USAGE TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. (1) DOSAGE AND ADMINISTRATION TROGARZO is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% Sodium Chloride Injection, USP. (2.1) DOSAGE FORMS AND STRENGTHS Injection: 200 mg/1.33 mL (150 mg/mL) in a single-dose vial. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies. (5.1) ADVERSE REACTIONS The most common adverse reactions (incidence ? 5%) were diarrhea, dizziness, nausea, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient supportTM at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 5/2018

RX ITEM-Trogarzo- Ibalizumab Injection S
NDC Code(s): 62064-122-01, 62064-122-02 Packager: Theratechnologies Inc. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: Biologic Licensing Application

Trogarzo- Ibalizumab Injection Solution
BRAND: TROGARZO NDC: RX62064-0122-01 ,RX62064012201 UPC: 362064-122013,362064122013 NDC Code(s): 62064-122-01, 62064-122-02 Packager: Theratechnologies Inc. Category: HUMAN PRESCRIPTION DRUG

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