Anpingxi Ripertamab Injection

1. Indications and Usage
Diffuse Large B-Cell Lymphoma (DLBCL): Indicated for adult patients with newly diagnosed, International Prognostic Index (IPI) score of 0-2, CD20-positive diffuse large B-cell lymphoma (DLBCL).
Combination Therapy: Must be used in combination with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone).
2. Dosage and Administration
Route of Administration: Intravenous infusion ONLY. The drug must not be administered as an intravenous bolus or push.
Recommended Dosage: 375 mg/m² body surface area (BSA) on Day 1 of each chemotherapy cycle.
Maximum Cycles: Up to 6 treatment cycles.
Premedication: Administer antipyretics (e.g., acetaminophen), antihistamines (e.g., diphenhydramine), and corticosteroids (e.g., dexamethasone) 30-60 minutes prior to infusion to reduce infusion-related reactions.
Infusion Rate: Initial infusion at 50 mg/h; if no reaction after 60 minutes, increase by 50 mg/h every 30 minutes up to a maximum of 400 mg/h.
3. Mechanism of Action
CD20 Binding: Ripertamab is a human-mouse chimeric monoclonal antibody that specifically binds to the CD20 antigen on the surface of pre-B and mature B lymphocytes.
Cell Lysis: Upon binding, it triggers immune-mediated B-cell lysis through complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC).
4. Safety and Warnings
Infusion-Related Reactions: Severe infusion reactions (e.g., bronchospasm, hypoxemia) may occur. Patients must be closely monitored, especially during the first infusion.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation may occur, potentially leading to fulminant hepatitis, liver failure, or death. Screen for HBV before initiation and monitor during and after treatment.
Tumor Lysis Syndrome: Evaluate for tumor lysis syndrome, especially in patients with high tumor burden, and perform appropriate laboratory tests.
Pulmonary Infiltrates: Patients with pre-existing pulmonary insufficiency or tumor pulmonary infiltration must undergo chest X-ray examination prior to treatment.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Neutropenia, leukopenia, anemia, alopecia, lymphopenia, nausea, upper respiratory tract infection, pyrexia, and thrombocytopenia.
Grade 3-4 Adverse Reactions: Neutropenia, leukopenia, lymphopenia, bone marrow failure, pulmonary infection, and anemia.
Clinical Research Highlights: In the pivotal trial (SCT400NHL3), Ripertamab combined with CHOP (S-CHOP) demonstrated comparable efficacy to Rituximab combined with CHOP (R-CHOP) in newly diagnosed DLBCL patients.
6. Drug Interactions
Other Monoclonal Antibodies: Patients with high titers of human anti-mouse antibodies (HAMA) or human anti-chimeric antibodies (HACA) may experience allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
CHOP Chemotherapy: The standard chemotherapy agents used with Ripertamab may have their own interaction profiles and toxicity concerns.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Ripertamab. Excipients include sodium citrate, polysorbate 80, sodium chloride, and water for injection.
Appearance: Colorless to pale yellow liquid, which may be slightly opalescent.
Packaging: Available in single-dose vials (e.g., 50 mg/5 mL, 100 mg/10 mL, 500 mg/50 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.