Ibalizumab

TROGARZO, 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. 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.

Ibalizumab-uiyk is an HIV-1 antiretroviral drug.

The recommended dosage regimen is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks administered as a diluted intravenous infusion (IV infusion) or undiluted intravenous push (IV push). Duration of IV Infusion or IV Push IV Infusion (Diluted) IV Push (Undiluted) Loading Dose 2,000 mg Over at least 30 minutes Over at least 90 seconds Maintenance Dose 800 mg Over at least 15 minutes Over at least 30 seconds

TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product. Prior hypersensitivity reaction to TROGARZO or any components of the product.

Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO. Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies. Embryo-Fetal Toxicity: Monitor infants exposed to TROGARZO in utero for signs and symptoms of immunosuppression.

The following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash.

Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and protect from light.