Daratumumab is now available on the Pharmaceutical Benefits Scheme (PBS) in the subcutaneous presentation, Darzalex® SC. The authority listing is for the second-line treatment of multiple myeloma.
Daratumumab is a monoclonal antibody that binds to the transmembrane protein, CD38. This protein has emerged as a target in multiple myeloma as it is highly expressed in plasma cells and plays an important role in the transduction of activating and proliferating signals. Daratumumab is thought to cause tumour cell lysis via multiple immune-mediated mechanisms.
The original formulation of Darzalex® was listed on the PBS in January 2021. This form is administered as an intravenous infusion that is given over several hours. The new listing of Darzalex® SC may provide a more convenient alternative for patients as it is administered subcutaneously over three to five minutes.
Both presentations of daratumumab can cause serious infusion-related reactions, and pre-medication is recommended to reduce this risk. Pre-medication consists of a corticosteroid (long-acting or intermediate-acting), antipyretic, and antihistamine. Post-injection corticosteroids may also be used to reduce the risk of delayed reactions. However, if no major infusion-related reactions occur after the first three doses of Darzalex® SC, post-injection corticosteroids may not be required.
- Darzalex® SC (Daratumumab) Australian approved product information. Macquarie Park: Janssen-Cilag. Approved October 2021.
- Morandi F, Airoldi I, Marimpietri D, Bracci C, Corso Faini A, Gramignoli R. CD38, a receptor with multifunctional activities: from modulatory functions on regulatory cell subsets and extracellular vesicles, to a target for therapeutic strategies. Cells 2019; 8(12): 1527.