TROGARZO (ibalizumab-uiyk)

TROGARZO (ibalizumab-uiyk)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• 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, to be used in combination with other antiretroviral(s)

Patients must meet the following criteria for the indication(s) above:

• Patients are 18 years of age or older, AND
• Diagnosis of multidrug resistant HIV-1 infection, AND
• Prescribed by or in consultation with an ID or HIV specialist, AND
• Documentation of resistance to at least 1 antiretroviral (ARV) drug from each of the 4 classes (NRTI, NNRTI, PI, INSTI), unless contraindicated, AND
• Failure of Fuzeon, unless resistant, contraindicated, or adverse effects are experienced, AND
• Failure of Selzentry, if CCR5-tropic, unless resistant, contraindicated, or adverse effects are experienced, AND
• Current HIV RNA viral load (within the past 30 days) of greater than or equal to 200 copies/mL, AND
• Trogarzo is prescribed concurrently with additional antiretroviral agent(s), AND
• Dose is no greater than 2,000mg (10 vials) IV loading dose and/or 800mg (4 vials) IV every 14 days

Dosing:

• Loading dose: 2,000mg once
• Maintenance dose: 800mg every 2 weeks

Approval:

• 6 months