Tafasitamab-cxix
Tafasitamab-cxix Uses, Dosage, Side Effects, Food Interaction and all others data.
Tafasitamab-cxix is a humanized, CD19-directed cytolytic monoclonal antibody intended for the treatment of B-cell malignancies. It is produced using recombinant DNA technology in Chinese hamster ovary cells, and contains an IgG1/2 hybrid Fc-domain which has been modified with 2 amino acid substitutions to enhance its cytotoxicity relative to non-engineered anti-CD19 antibodies.
The CD19 surface protein is highly expressed on the surface of B-cells, where it appears to play a role in enhancing B-cell receptor signaling. Its relative ubiquity across different stages of B-cell development, including pre-B and mature B-lymphocytes, as well as its presence in several B-cell malignancies (e.g. chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL)) has made it a desirable target in the treatment these B-cell malignancies. Tafasatimab is designed to bind to and block the activity of the CD19 surface antigen, which ultimately results in the lysis of B-cells (both healthy and malignant).
Having previously received Breakthrough Therapy, Fast Track, and Orphan designations from the FDA, tafasatimab-cxix (Monjuvi®) received an accelerated approval on July 31st, 2020, for the treatment of relapsed or refractory DLBCL in adult patients who cannot receive autologous stem cell transplants. It must be used in combination with lenalidomide, as this combination results in greater efficacy as compared to either agent alone.
| Trade Name | Tafasitamab-cxix |
| Availability | Prescription only |
| Generic | Tafasitamab |
| Tafasitamab Other Names | Tafasitamab, tafasitamab-cxix |
| Related Drugs | prednisone, rituximab, Rituxan, doxorubicin, cyclophosphamide, vincristine |
| Type | Intravenous |
| Weight | 150000.0 Da |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Tafasitamab-cxix is a CD19-directed cytolytic monoclonal antibody used in the treatment of B-cell malignancies.
Tafasitamab-cxix is indicated, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified whom are ineligible for autologous stem cell transplant (ASCT).
Tafasitamab-cxix is also used to associated treatment for these conditions: Refractory Diffuse large B-cell lymphoma NOS, Relapsed Diffuse large B-cell lymphoma NOS
How Tafasitamab-cxix works
The CD19 surface antigen is a protein expressed on the surface of pre-B and mature B-lymphocytes that appears to play a role in enhancing B-cell receptor signaling and is considered integral to their survival. These surface proteins are also highly expressed on several B-cell malignancies, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL).
Tafasitamab-cxix is a CD19-directed cytolytic monoclonal antibody that, upon binding and blocking the activity of CD19, causes lysis of B-cells. This process is mediated through both direct apoptosis and immune-mediated effector mechanisms, such as antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Toxicity
Data regarding overdose of tafasitamab are unavailable. Symptoms of overdosage are likely to be consistent with its adverse effect profile, and may therefore involve significant infusion-related reactions and/or myelosuppression.
Food Interaction
No interactions found.Volume of Distribution
The total volume of distribution of tafasitamab following intravenous injection is approximately 9.3 L.
Elimination Route
Following intravenous administration of tafasitamab 12 mg/kg on Days 1, 8, 15, and 22 in cycle(s) 1-3 (with an additional dose on Day 4 of cycle 1), mean trough concentrations were 179 (± 53) μg/mL. From cycle 4 onwards, which involve the administration of tafasitamab 12 mg/kg on Days 1 and 15, mean trough concentrations were 153 (± 68) μg/mL.
The overall maximum tafasitamab serum concentrations reached were 483 (± 109) μg/mL.
Half Life
The terminal elimination half-life of tafasitamab is approximately 17 days.
Clearance
The clearance of tafasitamab is approximately 0.41 L/day.
Elimination Route
Monoclonal antibodies are typically eliminated via uptake into cells and subsequent catabolism via lysosomal degradation. Due to their large size, they are only eliminated renally under pathologic conditions.
Innovators Monograph
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