Formulation and specifications: Powder injection: 50mg/vial
Indications: Patients with relapsed or refractory systemic mesenchymal large cell lymphoma. Patients with relapsed or refractory classic Hodgkin’s lymphoma.
Key points for rational drug use:
1. Peripheral neuropathy: Vibutuximab treatment can cause sensory and motor peripheral neuropathy with cumulative effects that may require delayed dosing or discontinuation of therapy.
2. Infusion-related reactions: The incidence of infusion reactions to monotherapy is 13%, and the incidence of grade 3 events is 9.8%. Hypersensitivity reactions are rare, and if they occur, the infusion should be terminated immediately and treated accordingly.
3. Hematologic toxicity: Before each dose, the complete blood count should be monitored.
4. Tumor lysis syndrome: Patients with rapid tumor proliferation and high tumor load have a higher risk of tumor lysis syndrome and should be closely monitored and appropriate measures should be taken.
5. Severe skin reactions: including Stevens-Johnson syndrome and toxic epidermal necrolysis relaxation syndrome. If they occur, vibutuximab administration should be discontinued and appropriate treatment should be provided.
6. Pulmonary toxicity: including pneumonia, interstitial pneumonia and acute respiratory distress syndrome, should be monitored and avoided in combination with bleomycin.
7. Vibutuximab interacts with drugs metabolized by the CYP3A4 pathway (CYP3A4 inhibitors/inducers): e.g., combination with ketoconazole may increase the incidence of neutropenia; rifampin has no effect on plasma exposure of vibutuximab.
8. Increased toxicity in patients with severe renal impairment: mainly caused by its covalently coupled microtubule inhibitor monomethyl auristatin E aggregation; avoid use of vibutuximab in patients with severe renal impairment (creatinine clearance <30 ml/min).
※9. Additional indications for FDA approval: adult patients with primary cutaneous mesenchymal large cell lymphoma or CD30-positive mycosis fungoides who have received prior systemic therapy; combination chemotherapy for primary stage III or IV classic Hodgkin’s lymphoma, primary systemic mesenchymal large cell lymphoma, or other CD30-expressing peripheral T-cell lymphoma.