tafasitamab: clinical use

Prescribing considerations

• Treatment should be supervised by clinicians experienced in cancer care.
• Treat and adequately control active infection before administration; assess recurrent or chronic infection history.
• Use premedication and close observation to reduce and detect infusion reactions.
• Assess tumour burden and tumour-lysis risk, using appropriate prophylaxis where indicated.
• For follicular lymphoma, consider the uncertain benefit where disease is CD19-negative or CD20-negative.
• Record the product name and batch number for biological-medicine traceability.
• Apply the relevant safety requirements for lenalidomide and rituximab when co-prescribed.

Contraindications and cautions

• Hypersensitivity to tafasitamab or any listed excipient.
• Use caution with active, recurrent or chronic infection, significant cytopenias, high tumour burden and known polysorbate allergy.
• Safety and efficacy have not been established in people under 18 years; clinical data are limited in advanced renal or hepatic impairment.

Monitoring

• Full blood count at baseline and throughout treatment, with particular attention to neutrophils, platelets and haemoglobin.
• Signs and symptoms of infection during and after treatment.
• Vital signs and symptoms of infusion reactions during administration and for delayed reactions.
• Biochemistry and clinical features of tumour lysis syndrome in at-risk patients.
• New or worsening neurological symptoms suggesting PML; suspend treatment while investigated.
• Bruising or bleeding, particularly when anticoagulants or antiplatelet medicines are used.

Clinical pharmacology

Tafasitamab is a humanised, Fc-enhanced IgG monoclonal antibody directed against CD19. It promotes antibody-dependent cellular cytotoxicity and phagocytosis and can directly induce B-cell apoptosis. Like other IgG antibodies, it is expected to be broken down into peptides and amino acids.

Formulation and product differences

• Supplied as a sterile, preservative-free powder in a single-use vial.
• Requires aseptic reconstitution and dilution before intravenous infusion.
• The prepared solution should not be shaken or frozen.
• Contains sodium and polysorbate 20; polysorbates can cause allergic reactions.
• Unopened vials require refrigerated, light-protected storage.

Solution for infusion

Route: Intravenous

Strengths: 200 mg