Drug Guide
Ibalizumab-uiyk
Classification
Therapeutic: Antiretroviral Agent for HIV Infection
Pharmacological: Monoclonal Antibody
FDA Approved Indications
- Treatment of Multi-Drug Resistant HIV-1 Infection in adults when other treatment options have failed
Mechanism of Action
Ibalizumab-uiyk is a humanized monoclonal antibody that binds to the CD4 receptor on T-cells, blocking HIV-1 from entering and infecting the cells, thereby preventing viral replication.
Dosage and Administration
Adult: 800 mg IV loading dose at week 1, then 800 mg every 2 weeks as maintenance dose
Pediatric: Not established
Geriatric: No specific dosage adjustment; monitor carefully
Renal Impairment: No dosage adjustment needed for renal impairment
Hepatic Impairment: No specific data; use caution and monitor closely
Pharmacokinetics
Absorption: Administered intravenously, so absorption is complete and immediate
Distribution: Widely distributed in body tissues; details not fully defined
Metabolism: Metabolized via typical protein degradation pathways, not through hepatic enzymes
Excretion: Primarily via proteolytic catabolism, not renal or hepatic pathways
Half Life: Approximately 3 days (72 hours)
Contraindications
- Known hypersensitivity to ibalizumab-uiyk or any component
Precautions
- Use with caution in patients with known hypersensitivity reactions; monitor for infusion-related reactions and hypersensitivity. Consider the potential for immune-mediated reactions.
Adverse Reactions - Common
- Diarrhea (Unknown)
- Nausea (Unknown)
- Rash (Unknown)
Adverse Reactions - Serious
- Infusion-related reactions (allergic reactions, hypersensitivity) (Rare)
- Immune-mediated events, including hypersensitivity reactions (Rare)
Drug-Drug Interactions
- No significant interactions reported, but caution with other immunomodulating agents
Drug-Food Interactions
- No relevant interactions established
Drug-Herb Interactions
- No data available
Nursing Implications
Assessment: Monitor for infusion-related reactions during and after administration; assess for signs of hypersensitivity; monitor viral load and CD4 counts periodically.
Diagnoses:
- Risk for allergic reaction or infusion reaction
- Impaired immunity
Implementation: Administer IV infusion slowly according to prescribed rate; prepare emergency equipment for hypersensitivity reactions; observe patient closely during and after infusion.
Evaluation: Evaluate viral load response and CD4 counts; monitor for adverse reactions and infusion site reactions.
Patient/Family Teaching
- Report any symptoms of allergic or infusion reactions immediately.
- Educate about the importance of adherence to therapy and follow-up visits.
- Inform about possible side effects and when to seek medical attention.
Special Considerations
Black Box Warnings:
- Infusion-related hypersensitivity reactions, including anaphylaxis, have been reported; patients should be observed closely during and after infusion.
- Potential for immune-mediated adverse reactions.
Genetic Factors: None established.
Lab Test Interference: No known interference with routine laboratory tests.
Overdose Management
Signs/Symptoms: Infusion reactions, hypersensitivity
Treatment: Discontinue infusion immediately; provide supportive care; manage symptoms of hypersensitivity or allergic reactions as per standard protocols.
Storage and Handling
Storage: Store vials at 2°C to 8°C (36°F to 46°F); keep in original carton to protect from light.
Stability: Stable up to the expiration date when stored properly.