Daratumumab

DEA Class; Rx

Common Brand Names; Darzalex

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

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

Daratumumab 

injectable solution, single-use vial

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