2,000 mg as an IV infusion.
800 mg as an IV infusion every 2 weeks following the initial loading dose. If a maintenance dose (800 mg) is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible. Resume maintenance dosing (800 mg) every 14 days thereafter.
No dose modifications required when administered with any other antiretroviral or any other treatments.
■ No formal studies conducted to examine the effects of renal or hepatic impairment on the pharmacokinetics of ibalizumab-uiyk. Renal impairment is not anticipated to affect the pharmacokinetics of ibalizumab-uiyk.
Available in a single-dose vial containing 200 mg/1.33 mL (150 mg/mL). Solution is colorless to slightly yellow and clear to slightly opalescent. Ten vials (13.3 mL) are required for the loading dose. Four vials are required for the maintenance dose (5.32 mL). Withdraw 1.33 mL of solution from each vial and transfer into a 250 mL IV bag of NS. Once diluted, the solution should be administered immediately.
Specific information not available.
Before use, refrigerate vials at 2° to 8° C (36° to 46° F) in original cartons to protect from light. Do not freeze. Once diluted, the ibalizumab-uiyk solution should be administered immediately. If not administered immediately, store diluted solution at RT (20° to 25° C [68° to 77° F]) for up to 4 hours, or refrigerate (2° to 8° C [36° to 46° F]) for up to 24 hours. If refrigerated, allow the diluted solution to stand at RT for at least 30 minutes but no more than 4 hours before administration. Discard partially used or empty vials and any unused portion of the diluted solution.
Compatible only with NS. Manufacturer states, “Other IV diluents must not be used to prepare ibalizumab-uiyk solution for infusion.”
Do not administer as an IV push or bolus. Manufacturer suggests administration into the cephalic vein of the patient’s right or left arm. If cephalic vein is not accessible, an appropriate vein located elsewhere can be used.
The duration of the first infusion (loading dose) should be no less than 30 minutes.
If no infusion reactions have occurred with the loading dose, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes. After infusion is complete, flush with 30 mL NS.
Ibalizumab-uiyk is a CD4-directed postattachment HIV-1 inhibitor. It is a recombinant humanized monoclonal antibody that blocks HIV-1 from infecting CD4+ T-cells by binding to domain 2 of CD4 and interfering with the postattachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. The binding specificity of ibalizumab-uiyk to domain 2 of CD4 allows ibalizumab-uiyk to block viral entry into host cells without causing immunosuppression.
Given in combination with other antiretroviral(s) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are failing their current antiretroviral regimen.
Immune reconstitution inflammatory syndrome has been reported. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may require further evaluation and treatment.
■ Infusion-associated reactions may occur.
■ As with all therapeutic proteins, there is potential for immunogenicity.
Monitor during and for 1 hour after completion of ibalizumab-uiyk administration for at least the first infusion. If no infusion-associated adverse reaction is observed, the postinfusion observation time may be reduced to 15 minutes.
■ Monitor patient for any new symptoms after receiving ibalizumab-uiyk.
Read the FDA-approved patient information.
■ Review all medicines being taken, including prescription and nonprescription medications, with health care provider.
■ Immediately report any S/S of infection.
■ It is important to receive ibalizumab-uiyk injections every 2 weeks and not to change the dosing schedule or any antiretroviral medication without consulting with health care provider. Immediately contact health care provider if ibalizumab-uiyk or any other drug in antiretroviral regimen is stopped.
No adequate human data are available to establish whether ibalizumab-uiyk poses a risk to pregnancy outcomes.
■ A pregnancy exposure registry has been established; contact manufacturer.
■ Females infected with HIV should be instructed not to breast-feed due to the potential for HIV transmission to the infant.
■ Safety and effectiveness for use in pediatric patients have not been established.
No studies have been conducted in elderly patients.
No drug interaction studies have been conducted. Based on ibalizumab-uiyk’s mechanism of action and target-mediated drug disposition, drug-drug interactions are not expected.
The most common side effects were diarrhea, dizziness, nausea, and rash. Severe rash occurred in one patient, and immune reconstitution inflammatory syndrome (manifested as an exacerbation of progressive multifocal leukoencephalopathy) occurred in another. Laboratory abnormalities include elevated bilirubin, direct bilirubin, creatinine, blood glucose, lipase, and uric acid, and decreased hemoglobin, platelets, leukocytes, and neutrophils.