.Pharmacolibrary.Drugs.ATC.L.L01FC01

Information

Daratumumab is a human IgG1κ monoclonal antibody that targets CD38, a glycoprotein highly expressed on myeloma cells. It is used for the treatment of multiple myeloma, either as monotherapy or in combination with other agents. Daratumumab is approved for clinical use and is widely used in current therapeutic regimens for relapsed/refractory multiple myeloma.

Pharmacokinetics

Pharmacokinetic parameters reported for adult patients (both sexes, median age ~64) with relapsed/refractory multiple myeloma administered daratumumab 16 mg/kg intravenously, data from clinical trials population PK models.

References

1. Mateos, MV, et al., & Usmani, SZ (2020). Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. The Lancet. Haematology 7(5) e370–e380. DOI:10.1016/S2352-3026(20)30070-3 PUBMED:https://pubmed.ncbi.nlm.nih.gov/32213342

2. Dosne, AG, et al., & Xu, Y (2023). Population pharmacokinetics and exposure-response analyses of daratumumab plus pomalidomide/dexamethasone in relapsed or refractory multiple myeloma. British journal of clinical pharmacology 89(5) 1640–1655. DOI:10.1111/bcp.15628 PUBMED:https://pubmed.ncbi.nlm.nih.gov/36484341

3. Xu, XS, et al., & Clemens, PL (2020). Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses. Advances in therapy 37(4) 1464–1478. DOI:10.1007/s12325-020-01247-8 PUBMED:https://pubmed.ncbi.nlm.nih.gov/32078124

Revisions

• 06/2025 initial generated model