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Daratumumab

    Brands

    DEA Class; Rx

    Common Brand Names; Darzalex

    • Antineoplastics, Monoclonal Antibody; 
    • Antineoplastics, Anti-CD38 Monoclonal Antibodies

    Anti-CD38 monoclonal antibody
    Used as monotherapy or in combination with other agents for multiple myeloma
    Type and cross-match patient blood prior to starting treatment

    Multiple Myeloma

    Newly diagnosed multiple myeloma

    • Combination therapy with bortezomib, melphalan, and prednisone
      • Indicated in combination with bortezomib, melphalan, and prednisone for newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (ASCT)
    • Combination therapy with lenalidomide and dexamethasone
      • Indicated in combination with lenalidomide and low-dose dexamethasone for newly diagnosed multiple myeloma in patients who are ineligible for ASCT
    • Combination therapy with bortezomib, thalidomide, and dexamethasone
      • Indicated in combination with bortezomib, thalidomide, and prednisone for newly diagnosed multiple myeloma in patients who are eligible for ASCT

    Relapsed/refractory multiple myeloma

    • Monotherapy
      • Indicated as monotherapy for multiple myeloma in patients who have received at least 3 lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and IMiD
    • Combination therapy with bortezomib and dexamethasone
      • Indicated in combination with bortezomib and low-dose dexamethasone for multiple myeloma in patients who have received at least 1 prior therapy
    • Combination therapy with lenalidomide and dexamethasone
      • Indicated in combination with lenalidomide and low-dose dexamethasone for multiple myeloma in patients who have received at least 1 prior therapy
    • Combination therapy with pomalidomide and dexamethasone
      • Indicated in combination with pomalidomide and low-dose dexamethasone for with multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
    • Combination therapy with carfilzomib and dexamethasone
      • Indicated in combination with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma in patients who have received 1-3 prior lines of therapy

    Hypersensitivity to drug or components of the formulation

    Monotherapy

    • Lymphopenia (72%)
    • Neutropenia (60%)
    • Infusion reaction (48%)
    • Thrombocytopenia (48%)
    • Anemia (45%)
    • Fatigue (39%)
    • Lymphopenia, Grade 3 (30%)
    • Nausea (27%)
    • Back pain (23%)
    • Pyrexia (21%)
    • Cough (21%)
    • Upper respiratory tract infection (20%)
    • Anemia, Grade 3 (19%)
    • Neutropenia, Grade 3 (17%)
    • Nasal congestion (17%)
    • Arthralgia (17%)
    • Diarrhea (16%)
    • Constipation (15%)
    • Pain in extremity (15%)
    • Dyspnea (15%)
    • Nasopharyngitis (15%)
    • Decreased appetite (15%)
    • Vomiting (14%)
    • Musculoskeletal chest pain (12%)
    • Headache (12%)
    • Pneumonia (11%)

    Combination therapy with pomalidomide and dexamethasone

    • Fatigue (50%)
    • Infusion-related reaction (50%)
    • Upper respiratory tract infection (50%)
    • Cough (43%)
    • Diarrhea (38%)
    • Constipation (33%)
    • Dyspnea (33%)
    • Nausea (30%)
    • Muscle spasms (26%)
    • Back pain (25%)
    • Pyrexia (25%)
    • Insomnia (23%)
    • Arthralgia (21%)
    • Vomiting (21%)
    • Chills (20%)
    • Tremor (19%)
    • Headache (17%)
    • Peripheral edema (17%)
    • Hypokalemia (16%)
    • Nasal congestion (16%)
    • Asthenia (15%)
    • Non-cardiac chest pain (15%)
    • Pneumonia (15%)
    • Hyperglycemia (13%)
    • Anxiety (13%)
    • Decreased appetite (11%)
    • Pain (11%)

    May increase neutropenia and/or thrombocytopenia induced by background therapy; monitor CBC counts periodically during treatment; monitor patients with neutropenia for signs of infection; dose delay may be required to allow recovery of neutrophils; no dose reduction is recommended, consider supportive care with growth factors and/or transfusions

    Binds to CD38 on RBCs and may result in a positive indirect antiglobulin test (Coombs test)

    May cause false-positive results with serum protein electrophoresis (SPE) and immunofixation (IFE) assays

    Hepatitis B virus reactivation reported in clinical trials; including fatal cases

    There are no human data to inform a risk with use of daratumumab during pregnancy and animal studies have not been conducted

    Unknown if distributed in human breast milk

    Adults

    16 mg/kg/dose (actual body weight) IV.

    Geriatric

    16 mg/kg/dose (actual body weight) IV.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    Daratumumab 

    injectable solution, single-use vial

    • 100mg/5mL (20mg/mL)
    • 400mg/20mL (20mg/mL)
    • Requires further dilution prior to administration