Monjuvi (tafasitamab-cxix)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Tafasitamab, an anti-CD19 monoclonal antibody, is an antineoplastic agent.
Tafasitamab, a recombinant humanized anti-CD19 monoclonal antibody, is an antineoplastic agent. The drug is an Fc-modified IgG1-IgG2 kappa immunoglobulin produced by recombinant DNA technology in mammalian cell (Chinese hamster ovary) culture. Tafasitamab binds specifically to the antigen CD19, a cell-surface antigen expressed on malignant B-lymphocytes, including diffuse large B-cell lymphoma (DLBCL) cells.
CD19 is critically involved in enhancing B-cell receptor signaling and activation of downstream signaling pathways (i.e., Src family, Ras family, Bcr-Abl, BTK, Vav, Grb2, PI3K) that play a crucial role in tumor cell proliferation and survival. Following binding of tafasitamab to antigen CD19, the Fc domain triggers host immune responses (i.e., antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP)) causing lysis of the B-cells. In vitro in DLBCL tumor cells, the combination of tafasitamab and lenalidomide increased ADCC activity compared with either drug alone.
In patients with relapsed or refractory DLBCL, peripheral blood B-cell counts are reduced by 97% after 8 days of tafasitamab treatment and reach a nadir (100% reduction) within 16 weeks of treatment. As a human IgG monoclonal antibody, the drug is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The terminal half-life of tafasitamab is approximately 17 days.
The pharmacokinetics of tafasitamab do not appear to be affected by age (16-90 years) and sex. Dosage of tafasitamab is based on body weight because clearance and volume of distribution of the drug are expected to increase with increasing body weight.
USES: This medication is used to treat certain types of cancer (diffuse large B-cell lymphoma, follicular lymphoma). Tafasitamab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.
Generic name: tafasitamab-cxix
Pronunciation: (TA-fa-SIT-a-mab)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Monjuvi
Indications
The following indications are listed for Monjuvi:
- Follicular Lymphoma
- Progressive Diffuse Large B-Cell Lymphoma
Also known as: Follicular B-Cell Lymphoma, Follicular B-Cell Non-Hodgkin's Lymphoma.
Dosing
Clinicians should consult the respective manufacturers' labelings or published protocols for information on the dosage adjustments of other antineoplastic agents used in combination regimens.
Tafasitamab-cxix is administered by IV infusion. Tafasitamab-cxix should not be administered simultaneously through the same IV line with any other drug.
The manufacturer states that no incompatibilities between tafasitamab-cxix and infusion containers made of PVC, polypropylene, polyethylene, polyethylenterephthalate, or glass and administration sets made of polyurethane or PVC have been observed.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 20% or more of patients receiving tafasitamab-cxix in combination with lenalidomide for the treatment of relapsed or refractory DLBCL include neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of tafasitamab have not been established in pediatric patients.
There are no adequate and well-controlled studies of tafasitamab in pregnant women. Animal reproduction studies have not been performed to date with the drug.
When tafasitamab is administered in combination with lenalidomide, clinicians must consider that lenalidomide is contraindicated in pregnant women. (See Combination Therapy under Cautions.)
It is not known whether tafasitamab is distributed into human milk; however, maternal IgG is known to be present in human milk. The effects of the drug on nursing infants or on the production of milk are unknown.
Because of the potential for adverse reactions to tafasitamab in nursing infants, women should be advised not to nurse while receiving the drug and for at least 3 months after the last dose.
Clinical studies of tafasitamab-cxix did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. In the principal efficacy study evaluating tafasitamab-cxix in combination with lenalidomide, 72% of patients with relapsed or refractory DLBCL were 65 years of age or older and 38% were 75 years of age or older. Serious adverse effects occurred more frequently in geriatric patients compared to younger adults (57 versus 39%, respectively).
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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