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daratumumab (Darzalex)

Indications: - multiple myeloma - in combination with lenalidomide & dexamethasone, or bortezomib & dexamethasone (at least one prior therapy) - in combination with pomalidomide & dexamethasone (at least two prior therapies including lenalidomide & a proteasome inhibitor) - as monotherapy (at least three prior lines of therapy including a proteasome & an immunomodulatory agent & double refractory to proteasome inhibitor & immunomodulatory agent) [3] - ANCA-associated vasculitis [4] * daratumumab combined with bortezomib, melphalan, & prednisone reduces risk of disease progression or death in patients with stem-cell ineligible multiple myeloma than same regimen without daratumumab [2] Contraindications: - pregnancy & use within 3 months prior to pregnancy Dosgae: - infusion - vial: 20 mg/mL Injection [Darzalex] 20 mL Adverse effects: - most common - infusion-related reactions - fatigue - nausea, - back pain - fever - cough - other - pancytopenia - lymphopenia - neutropenia - anemia - thrombocytopenia - increased risk of infection [2] Laboratory: - may interfere with blood bank antibody screening tests - erythrocytes express CD-38 - CD38 with daratumumab bound may result in a false-positive indirect Coombs test [3] Mechanism of action: - CD38 inhibitor

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

Related

isatuximab isatuximab-irfc (Sarclisa)

General

antineoplastic monoclonal antibody

References

  1. FDA News Release. November 16, 2015 FDA approves Darzalex for patients with previously treated multiple myeloma http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm
  2. Mateos MV, Dimopoulos MA, Cavo M et al Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. Dec 12, 2017 PMID: 29231133 http://www.nejm.org/doi/full/10.1056/NEJMoa1714678
  3. Minerd J with Expert Critique from Short NJ Tips for Using Daratumumab. What clinicians should know about this new option for multiple myeloma. MedPage Today. ASCO Reading Room. March 14, 2018 https://www.medpagetoday.com/reading-room/asco/hematologic-malignancies/71748
  4. Rixecker TM, Leppervpm, Mang S et al Daratumumab for a Patient With Refractory Antineutrophil Cytoplasmatic Antibody- Associated Vasculitis. JAMA Intern Med. Published online April 10, 2023 PMID: 37036724 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2803783