belantamab mafodotin: clinical use

Prescribing considerations

• Initiate and monitor under a clinician experienced in multiple myeloma treatment.
• Arrange ophthalmic assessment before and during treatment.
• Ensure access to preservative-free artificial tears and reinforce avoidance of contact lenses unless ophthalmologist-directed.
• Use particular caution with existing ocular disease, thrombocytopenia, concurrent anticoagulation, unexplained pulmonary symptoms or positive hepatitis B serology.
• Clinical data are limited in moderate hepatic impairment and unavailable in severe hepatic impairment.
• Consider fertility-preservation counselling before treatment.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to belantamab mafodotin or any formulation excipient.

Monitoring

• Ophthalmic examination findings, best-corrected visual acuity and reported eye symptoms
• Full blood count, particularly platelet and neutrophil counts
• Bleeding, infection and infusion reactions
• New or worsening cough, dyspnoea or chest symptoms
• Clinical and laboratory evidence of hepatitis B reactivation when serology is positive
• Liver abnormalities and other treatment-emergent toxicity as clinically indicated

Clinical pharmacology

A humanised IgG1 antibody–cytotoxic conjugate targeting BCMA. Internalisation releases cys-mcMMAF, causing microtubule disruption, cell-cycle arrest and apoptosis; immune-mediated cytotoxicity and phagocytosis also contribute.

Formulation and product differences

• Two single-use vial presentations are available as powder for concentrate; both produce the same concentration after reconstitution.
• The formulation contains polysorbate 80 and is essentially sodium-free.
• Reconstitution, dilution and cytotoxic handling require trained healthcare staff; intravenous push or bolus administration is unsuitable.

Solution for infusion

Route: Intravenous

Strengths: 70 mg, 100 mg