Overview
11 DESCRIPTION Tafasitamab-cxix is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. It is produced by recombinant DNA technology in mammalian cells (Chinese hamster ovary). Tafasitamab-cxix has a molecular weight of approximately 150 kDa.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone. 12.
Indications
- 1 INDICATIONS AND USAGE MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.
Common Doses
- 12 mg
- 25 mg
- 20 mg
- 375 mg
Dosage
2 DOSAGE AND ADMINISTRATION Administer premedications prior to starting MONJUVI. ( 2.4 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) Diffuse Large B-cell Lymphoma The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.2 ) Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.
Contraindications
- 4 CONTRAINDICATIONS None. None.
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Infections [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 20%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite. ( 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.