Anruixi Zuberitamab Injection

1. Indications and Usage
Diffuse Large B-Cell Lymphoma (DLBCL): Treatment of adult patients with CD20-positive, non-specialized diffuse large B-cell lymphoma (DLBCL, NOS) in combination with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone).
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY.
Recommended Dosage: 375 mg/m² administered on day 1 of each chemotherapy cycle.
Cycle Schedule: Treatment is typically repeated every 21 days for a maximum of 6 cycles.
Critical Administration Instructions:
Preparation: Dilute the required dose in 0.9% Sodium Chloride to a final concentration of 1 mg/mL using aseptic technique.
Infusion Rate: Start at 50 mg/hour. If tolerated, the rate may be gradually increased by 50 mg/hour every 30 minutes up to a maximum of 400 mg/hour.
Premedication: Premedication with antihistamines, analgesics, and corticosteroids is recommended prior to infusion to mitigate infusion-related reactions.
3. Mechanism of Action
CD20 Binding: Zuberitamab is a chimeric monoclonal antibody that specifically binds to the CD20 antigen on the surface of B-lymphocytes.
B-Cell Depletion: By binding to CD20, it induces B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Antitumor Effect: This depletion mechanism enhances the antitumor activity of the concomitant chemotherapy agents used in the CHOP regimen.
4. Safety and Warnings
Infusion-Related Reactions: Severe infusion reactions (e.g., fever, chills, hypotension, bronchospasm) may occur and typically present within the first 30-120 minutes of the initial infusion. Infusion must be interrupted for severe reactions.
HBV Reactivation: Zuberitamab can cause Hepatitis B Virus (HBV) reactivation, potentially leading to fulminant hepatitis, liver failure, and death. Patients must be screened for HBV markers before initiation.
Severe Infections: The drug causes B-cell depletion and may increase susceptibility to severe infections. It is contraindicated in patients with severe active infections.
Tumor Lysis Syndrome (TLS): TLS may occur in patients with high tumor burden; appropriate medical management and hydration must be in place.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: The most common adverse reactions include hematological toxicity (neutropenia, leukopenia, anemia, thrombocytopenia), infusion-related reactions, fever, chills, and pneumonia.
Clinical Research Highlights: In a pivotal Phase 3 trial (Hi-CHOP study), Zuberitamab combined with CHOP demonstrated efficacy comparable to Rituximab combined with CHOP (R-CHOP) in patients with untreated DLBCL, with a manageable safety profile.
6. Drug Interactions
Concomitant Chemotherapy: No specific pharmacokinetic interaction studies have been conducted. It is designed to be used concurrently with CHOP chemotherapy.
Live Vaccines: The use of live or live-attenuated vaccines is not recommended during treatment and for 12 months after the final dose due to the risk of impaired immune response.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Zuberitamab. Excipients: Sodium citrate, Sodium chloride, Polysorbate 80, and Citric acid.
Appearance: Colorless to pale yellow clear solution.
Packaging: Single-use vial (100 mg/10 mL).
Storage: Store at 2°C to 8°C. Do not freeze or shake.