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)
• ANCA-associated vasculitis

* 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

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

• drug adverse effects of pharmaceutical monoclonal antibodies

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

Mechanism of action

• CD38 inhibitor

More general terms

• antineoplastic monoclonal antibody

Additional terms

• isatuximab isatuximab-irfc (Sarclisa)

Component of

• daratumumab/hylenex