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Trogarzo Generic Name & Formulations
Legal Class
Rx
General Description
Ibalizumab-uiyk 200mg/1.33mL; soln for IV inj after dilution; preservative-free.
Pharmacological Class
CD4-directed post-attachment HIV-1 inhibitor.
How Supplied
Single-dose vials (2mL)—2
Manufacturer
Generic Availability
NO
Mechanism of Action
Ibalizumab-uiyk, a recombinant humanized monoclonal antibody, blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion.
Trogarzo Indications
Indications
In combination with other antiretroviral(s) for HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Trogarzo Dosage and Administration
Adult
May give loading dose as an IV infusion over ≥30mins or as an IV push over ≥90 seconds. May give subsequent maintenance doses as an IV infusion over ≥15mins or as an IV push over ≥30 seconds. 2000mg as a single loading dose administered either as a diluted IV infusion or undiluted IV push, followed by 800mg (maintenance dose) every 2 weeks administered either as a diluted IV infusion or undiluted IV push.
Children
Not established.
Trogarzo Contraindications
Not Applicable
Trogarzo Boxed Warnings
Not Applicable
Trogarzo Warnings/Precautions
Warnings/Precautions
Discontinue immediately if hypersensitivity reactions (including infusion-related or anaphylactic reactions) occur; treat appropriately. Immune reconstitution inflammatory syndrome (in combination with other antiretrovirals). Embryo-fetal toxicity. Pregnancy: may affect immune responses in infants exposed in utero; monitor for reversible immunosuppression; do immune phenotyping and consult expert. Nursing mothers: not recommended.
Trogarzo Pharmacokinetics
Distribution
Volume of distribution: 4.8 L.
Elimination
Half-life: 2.7–64 hours.
Trogarzo Interactions
Not Applicable
Trogarzo Adverse Reactions
Adverse Reactions
Diarrhea, dizziness, nausea, rash; lab abnormalities.
Trogarzo Clinical Trials
See Literature
Trogarzo Note
Notes
To register pregnant patients to the Antiretroviral Pregnancy Registry, call (800) 258–4263.
Trogarzo Patient Counseling
See Literature
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