Drug Guide
Zolbetuximab-clzb
Classification
Therapeutic: Anti-cancer agent, Monoclonal antibody
Pharmacological: CDH17-targeting monoclonal antibody
FDA Approved Indications
- Gastric or gastroesophageal adenocarcinoma expressing CLDN18.2
Mechanism of Action
Zolbetuximab binds to CLDN18.2, a protein expressed on gastric and gastroesophageal cancer cells, inducing antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) leading to tumor cell death.
Dosage and Administration
Adult: The dosage varies depending on the clinical trial protocol; commonly, it is administered intravenously every 3 weeks at doses determined by trial data.
Pediatric: Not established; currently under clinical investigation.
Geriatric: Dosing may require adjustment based on tolerability and renal/hepatic function.
Renal Impairment: No specific adjustments established; monitor closely.
Hepatic Impairment: No specific adjustments established; monitor closely.
Pharmacokinetics
Absorption: Not applicable; administered intravenously.
Distribution: Distribution primarily within the vascular and interstitial space.
Metabolism: Metabolized by proteolytic degradation into peptides and amino acids.
Excretion: Excreted via proteolytic pathways; no specific renal excretion data.
Half Life: Approximately 2-3 weeks, consistent with monoclonal antibodies.
Contraindications
- Hypersensitivity to zolbetuximab or other monoclonal antibodies.
Precautions
- Patients with prior allergic reactions to similar agents.
- Monitoring for infusion reactions during administration.
- Assess for signs of immune-related adverse events.
Adverse Reactions - Common
- Infusion reactions (fever, chills, hypotension) (Common)
- Nausea, fatigue (Common)
Adverse Reactions - Serious
- Immune-mediated adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies (Serious but less common)
- Severe infusion reactions or hypersensitivity (Less common)
Drug-Drug Interactions
- Other immunomodulatory agents, chemotherapy
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for infusion reactions, allergic responses, and immune-related adverse events.
Diagnoses:
- Risk for allergic reactions
- Impaired tissue integrity related to adverse events.
Implementation: Pre-medicate as indicated, monitor vital signs during infusion, observe for signs of adverse reactions.
Evaluation: Efficacy through tumor assessments, monitor for adverse effects.
Patient/Family Teaching
- Report any infusion reactions or allergic symptoms immediately.
- Inform about possible side effects and importance of follow-up.
- Avoid other immunosuppressive agents unless advised by the healthcare provider.
Special Considerations
Black Box Warnings:
- Severe infusion reactions
- Immune-mediated adverse reactions
Genetic Factors: Not specified
Lab Test Interference: No known interference.
Overdose Management
Signs/Symptoms: Unknown; monitor for hypersensitivity, infusion reactions, or other adverse effects.
Treatment: Supportive care; discontinue infusion, provide symptomatic treatment, and monitor until adverse effects subside.
Storage and Handling
Storage: Store refrigerated at 2-8°C (36-46°F). Do not freeze.
Stability: Stable under recommended storage conditions until the expiration date on the package.