Home Drug Guide Inebilizumab-cdon

Drug Guide

Generic Name

Inebilizumab-cdon

Brand Names Uplizna

Classification

Therapeutic: Immunosuppressant, Monoclonal Antibody

Pharmacological: Anti-CD19 Monoclonal Antibody

FDA Approved Indications

Adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are seropositive for anti-aquaporin-4 antibodies

Mechanism of Action

Inebilizumab-cdon targets CD19, a protein on the surface of B cells, leading to B cell depletion which reduces immune-mediated damage in NMOSD.

Dosage and Administration

Adult: The recommended dose is 300 mg administered intravenously on days 1 and 15, followed by 300 mg every 6 months.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustments available, use with caution.

Renal Impairment: No specific adjustments recommended.

Hepatic Impairment: No specific adjustments recommended.

Pharmacokinetics

Absorption: Administered via intravenous infusion; absorption discontinuous, directed into bloodstream.

Distribution: Widely distributed with extensive binding to B cells; specific volume of distribution not established.

Metabolism: Cleaved by proteolytic enzymes; degraded into amino acids.

Excretion: Excreted primarily in urine as metabolites; unchanged drug not applicable.

Half Life: Approximately 11 days.

Contraindications

Hypersensitivity to Inebilizumab or its components.

Precautions

Risk of infections due to immunosuppression; monitor for signs of infection, hepatitis B reactivation, and malignancies. Use with caution in patients with active infections or other immune deficiencies. Vaccination responses may be diminished.

Adverse Reactions - Common

Infusion-related reactions (fever, chills, hypotension) (Common)
Infections (upper respiratory, urinary tract infections) (Common)
Back pain (Common)

Adverse Reactions - Serious

Progressive multifocal leukoencephalopathy (PML) (Rare)
Severe infections (pneumonia, herpes zoster) (Rare)
Malignancies (Rare)

Drug-Drug Interactions

Other immunosuppressants, live vaccines (avoid simultaneous use)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Baseline immune status, history of infections, and vaccination status.

Diagnoses:

Risk for infection related to immunosuppressive therapy.

Implementation: Administer drug as per schedule, monitor for infusion reactions and infections, ensure vaccinations are current before therapy if possible.

Evaluation: Monitor patient for signs of infection, infusion reactions, and effectiveness in reducing NMOSD relapses.

Patient/Family Teaching

Report any signs of infection immediately.
Avoid live vaccines during treatment and for some months after.
Inform about possible infusion reactions and what to do.
Follow-up appointments for monitoring.

Special Considerations

Black Box Warnings:

Progressive multifocal leukoencephalopathy (PML)

Genetic Factors: No specific genetic considerations noted.

Lab Test Interference: May cause falsely low levels of B-cell markers, monitor immune status regularly.

Overdose Management

Signs/Symptoms: Unknown; monitor for exaggerated immunosuppression or infusion reactions.

Treatment: Supportive care, corticosteroids for infusion reactions, and infection management.

Storage and Handling

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

Stability: Stable until the expiration date when refrigerated. Do not freeze.