Ibalizumab-uiyk
Class: HIV Entry and Fusion Inhibitors
CAS Number: CAS-680188-33-4
Brands: Trogarzo
Introduction
Antiretroviral; HIV entry inhibitor; CD4-directed post-attachment HIV type 1 (HIV-1) inhibitor.
Uses for Ibalizumab-uiyk
Treatment of HIV Infection
Treatment of HIV-1 infection in antiretroviral-experienced (previously treated) adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen; used in conjunction with other antiretrovirals.
Designated an orphan drug by FDA for this indication.
Ibalizumab-uiyk Dosage and Administration
Administration
IV Administration
Administer by IV infusion. Must not be administered by rapid IV injection.
Must be diluted prior to administration.
Should be administered by a trained medical professional.
Observe patient for 1 hour after completion of initial IV infusion. May reduce post-infusion observation time to 15 minutes for subsequent infusions if infusion-associated adverse effects did not occur with initial infusion.
Administer diluted solution by IV infusion into cephalic vein of the right or left arm. If cephalic vein not accessible, use another appropriate vein.
After completion of IV infusion, flush IV administration set with 30 mL of 0.9% sodium chloride injection.
Dilution
Prior to dilution, concentrate should appear as a colorless to slightly yellow and clear to slightly opalescent solution; do not use if it appears cloudy or discolored or contains particles.
Use appropriate number of single-dose vials containing 150 mg of ibalizumab-uiyk per mL to prepare desired dose.
To prepare the 2-g loading dose, use 10 single-dose vials of the concentrate; withdraw 1.33 mL from each of the vials (total volume of 13.3 mL) and add to an IV infusion bag containing 250 mL of 0.9% sodium chloride injection.
To prepare an 800-mg maintenance dose, use 4 single-dose vials of the concentrate; withdraw 1.33 mL from each of the vials (total volume of 5.32 mL) and add to an IV infusion bag containing 250 mL of 0.9% sodium chloride injection.
Small residual amount of concentrate may remain in each vial; discard this unused portion.
Administer immediately after dilution (see Storage under Stability). If diluted solution refrigerated, let stand at room temperature for ≥30 minutes (but <4 hours) before administering.
Rate of Administration
Initial dose (loading dose): Administer by IV infusion over ≥30 minutes.
Maintenance doses: Administer by IV infusion over ≥15 minutes, unless infusion-associated reactions occurred with loading dose.
Dosage
Adults
Treatment of HIV Infection
IV
Antiretroviral-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen: Single loading dose of 2 g followed by maintenance dosage of 800 mg once every 2 weeks.
If a maintenance dose is missed by ≥3 days beyond scheduled day, administer a 2-g loading dose as soon as possible. Then, resume usually re...
