Tafasitamab-Cxix Application Scope

Diffuse Large B-cell Lymphoma (DLBCL): Approved for relapsed/refractory (R/R) DLBCL in adults who are not eligible for autologous stem cell transplant (ASCT), in combination with lenalidomide.
monjuvi tafasitamab-cxix

Tafasitamab-Cxix Characteristics

Ingredients: Recombinant humanized monoclonal antibody (anti-CD19) with Fc-modification for enhanced immune cell engagement .
Properties: – Molecular Weight: ~150 kDa (IgG1κ antibody)
– Appearance: Clear to opalescent, colorless to slightly yellow solution .
Specification: Single-dose vials: 200 mg/10 mL (20 mg/mL) .
Packaging Specification: Carton containing 1 vial .
Storage: Refrigerate at 2–8°C; protect from light. Do not freeze or shake .
Expiry Date: Check vial label (typically 24 months from manufacture if unopened) .
Executive Standard: Manufactured under FDA (U.S.) and EMA (EU) regulations .
Approval Number: – U.S. FDA Approval: July 2020 (accelerated approval)
– EMA Approval: January 2021 (conditional marketing authorization) .
Date of Revision: Latest updates as of 2023 (post-marketing studies ongoing) .
Manufacturer: MorphoSys AG (developed in collaboration with Incyte Corporation) .

Guidelines For The Use Of Tafasitamab-Cxix

Dosage and Administration: – Loading Phase: 12 mg/kg IV on Days 1, 4, 8, 15, and 22 of Cycle 1, then weekly in Cycle 2 .
– Maintenance: 12 mg/kg IV on Days 1 and 15 of each subsequent cycle (28-day cycles) until disease progression or unacceptable toxicity .
– Premedication: Administer corticosteroids, antihistamines, and antipyretics to reduce infusion-related reactions .

Adverse Reactions: Most common (≥20%): Neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, fever, peripheral edema .
Serious risks: Infections (e.g., pneumonia), severe infusion-related reactions, tumor lysis syndrome .

Contraindications: Hypersensitivity to tafasitamab or excipients .

Precautions: – Monitor for infections, cytopenias, and infusion-related reactions .
– Vaccination: Avoid live vaccines during treatment .
– Pregnancy/Breastfeeding: Not recommended (potential fetal harm; unknown excretion in milk) .

Tafasitamab-Cxix Interactions

Drug Interactions: – Lenalidomide: Synergistic effect but may increase myelosuppression (monitor blood counts) .
– Live Vaccines: Contraindicated due to immunosuppression .

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.