tafasitamab

Action and Spectrum

Action 

tafasitamab has a dual action: it first causes programmed cell death (apoptosis), which kills the targeted B cells directly, and then it stimulates the immune system to attack and destroy the malignant cells. 

Spectrum 

A wide range of B-cell lymphoma subtypes, such as diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), are responsive to tafasitamab. 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

All grades 

Pyrexia (24%) 

Peripheral edema (24%) 

Decreased appetite (22%) 

Magnesium decreased (22%) 

Urate increased (20%) 

Phosphate decreased (20%) 

Creatinine increased (20%) 

AST increased (20%) 

Back pain (19%) 

Neutropenia (51%) 

Glucose increased (49%) 

Calcium decreased (47%) 

Activated partial thromboplastin time increased (46%) 

Fatigue (38%) 

Anemia (36%) 

Diarrhea (36%) 

Gamma glutamyl transferase increased (34%) 

Thrombocytopenia (31%) 

Albumin decreased (26%) 

Cough (26%) 

Respiratory tract infection (24%) 

Hypokalemia (19%) 

Constipation (17%) 

Urinary tract infection (17%) 

Bronchitis (16%) 

Nausea (15%) 

Vomiting (15%) 

Muscle spasms (15%) 

Febrile neutropenia (12%) 

Black Box Warning

Black Box Warning: 

tafasitamab carries a black box warning for the possibility of neurotoxicity and cytokine release syndrome (CRS). CRS, a potentially fatal systemic inflammatory reaction that can happen when a significant number of immune cells are activated, has been documented in tafasitamab-treated individuals. 

Fever, chills, low blood pressure, rapid heartbeat, breathing difficulties, and severe nausea and vomiting are all possible signs of CRS. Confusion, delirium, seizures, or other neurological symptoms are only a few examples of neurotoxicity’s severe effects. 

Contraindication / Caution

Contraindication 

Hypersensitivity to tafasitamab or any of its ingredients that is well known. severe or fatal side effects from previous monoclonal antibody treatment. 

Caution 

Increased risk of infections: Tafasitamab can increase the risk of infections, including bacterial, viral, and fungal infections. Patients should be continuously watched for indications of infection, and if one appears, treatment should be halted or stopped. 

Breastfeeding and pregnancy: It is unknown whether tafasitamab is safe for use in these situations. Throughout therapy and for at least three months following the last dosage of tafasitamab, women who are or may become pregnant should use an effective form of contraception. 

tafasitamab can result in the reactivation of the hepatitis B virus (HBV) in patients who have already been exposed to the virus.

Pregnancy / Lactation

Pregnancy consideration:  

Pregnancy category: NA 

Lactation: The excretion of drug into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

tafasitamab is a monoclonal antibody drug that specifically targets the CD19 protein, which is expressed on the surface of B cells. 

The medication is an immunoglobulin G1 (IgG1) monoclonal antibody known as a chimeric immunoglobulin G1. 

tafasitamab interacts to the CD19 protein on the surface of B cells, resulting in the activation of several action mechanisms. The first step is to cause the targeted B cells to undergo programmed cell death (apoptosis), which destroys them. Second, it stimulates the body’s immune system, particularly macrophages and natural killer cells, to go after and destroy the malignant B cells. 

Pharmacodynamics:  

tafasitamab’s pharmacodynamics requires its precise binding to the CD19 protein on the surface of B cells, which has a few secondary effects. tafasitamab primarily targets B cells that express the CD19, which causes their depletion through several processes, including death. 

tafasitamab stimulates immune cells, including macrophages and natural killer cells, which are key components of the body’s defense mechanism against malignant cells. 

Suppression of B-cell receptor signalling: tafasitamab’s inhibition of CD19, a crucial part of the B-cell receptor signalling pathway, can have an impact on B-cell activation and proliferation. 

tafasitamab has been demonstrated to modify the tumour microenvironment, resulting in enhanced immune cell infiltration into the tumour as well as alterations in cytokine and chemokine production. 

Pharmacokinetics: 

Absorption 

Because tafasitamab is given as an intravenous infusion, absorption is not relevant. 

Distribution 

Volume of distribution for tafasitamab is around 5.7 L, which shows that it is primarily contained in plasma and interstitial fluid. Plasma proteins are not extensively bound by the medication. 

Metabolism 

Catabolism is the process by which tafasitamab is broken down into smaller peptides and amino acids during metabolism. tafasitamab is not metabolized by cytochrome P450 or any other drug-metabolizing enzymes. 

Elimination and Excretion 

tafasitamab in the urine and faces are the main ways in which it is gotten rid of. tafasitamab has a half-life of about 20 days before it leaves the body. 

Adminstartion

Administration: 

In a medical setting, tafsitamab is given as an intravenous infusion often over the course of several hours. Depending on the patient’s tolerance and any potential infusion-related responses, the infusion rate may be changed. 

tafasitamab dosage and frequency may differ based on the kind and stage of B-cell lymphoma being treated, as well as patient-specific variables like age, weight, and general health.  

Patient Information Leaflet

Patient information leaflet 

Generic Name: tafasitamab 

Pronounced: [TA-fa-SIT-a-mab] 

Why do we use methenamine? 

A monoclonal antibody drug called tafasitamab is used to treat specific forms of B-cell lymphomas. For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for an autologous stem cell transplant, it is licensed for use in conjunction with lenalidomide.