Yutuo Zimberelimab Injection

1. Indications and Usage
Recurrent/Refractory cHL: Indicated for adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed at least two systemic chemotherapies.
2. Dosage and Administration
Route of Administration: Intravenous infusion ONLY.
Recommended Dosage: 240 mg administered every 2 weeks until disease progression or the development of intolerable toxicity.
Administration Details: Infuse over 60 minutes. Do not administer as an intravenous bolus or push. No routine dose adjustments are required for hepatic impairment.
3. Mechanism of Action
PD-1 Blockade: Zimberelimab is a recombinant humanized IgG4 monoclonal antibody that binds to programmed death-1 (PD-1).
Immune Reinvigoration: By blocking the PD-1 pathway, it prevents tumor cells from evading immune surveillance, thereby enhancing the anti-tumor immune response mediated by T cells.
4. Safety and Warnings
Immune-Mediated Adverse Reactions (IMARs): Can cause severe, fatal, or life-threatening immune-mediated reactions affecting any organ system, including pneumonitis, colitis, hepatitis, endocrinopathies, and cutaneous reactions.
Infusion-Related Reactions: May cause hypersensitivity and infusion-related reactions.
Fetal Embryotoxicity: Can cause fetal harm if administered during pregnancy due to the role of PD-1 in maintaining maternal-fetal immune tolerance.
Infection Risk: Immune modulation may increase the risk of infectious complications.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Fatigue, pyrexia, chills, headache, rash, pruritus, diarrhea, nausea, vomiting, and decreased appetite.
Clinical Research Highlights: In the Phase II YH-S001-04 trial for relapsed/refractory cHL, demonstrated a favorable objective response rate and manageable safety profile.
6. Drug Interactions
Metabolic Enzymes: As a monoclon antibody, it is not metabolized by cytochrome P450 (CYP) enzymes; thus, CYP inhibitors or inducers are not expected to affect its pharmacokinetics.
Live Vaccines: The concurrent use of live or attenuated vaccines should generally be avoided during treatment.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Zimberelimab. Excipients include histidine, sucrose, polysorbate 80, and water for injection.
Appearance: Colorless to pale yellow clear to slightly opalescent solution.
Packaging: Available in single-dose vials (e.g., 120 mg/4 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake.