Daratumumab

Daratumumab Brand Name– DARZALEX

What is Daratumumab

Daratumumab is a human monoclonal antibody that binds to CD38 IgG1 (kappa subclass) and causes lysis of multiple myeloma cells.

It is indicated for the treatment of multiple myeloma as monotherapy or in combination with lenalidomide/dexamethasone, bortezomib/dexamethasone, pomalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone, or bortezomib/melphalan/prednisone.

Because daratumumab binds to CD38 on red blood cells, it may interfere with the ability to determine a patient’s blood type and result in a false positive indirect antiglobulin test (Coombs test).

Additionally, daratumumab may interfere with the determination of complete response or disease progression in some patients. Patients should have their blood typed and cross-matched prior to starting treatment

Indications

• multiple myeloma

For the treatment of multiple myeloma

NOTE: The FDA has designated daratumumab as an orphan drug for the treatment of multiple myeloma.

for the treatment of multiple myeloma in patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Side Effects

1. anaphylactoid reactions
2. anemia
3. anemia
4. anorexia
5. anorexia
6. antibody formation
7. anxiety
8. arthralgia
9. arthralgia
10. asthenia
11. atrial fibrillation
12. back pain
13. back pain
14. bone pain
15. bone pain
16. bronchospasm
17. candidiasis
18. chest pain (unspecified)
19. chills
20. constipation
21. constipation
22. cough
23. cough
24. diarrhea
25. diarrhea
26. dizziness
27. dizziness
28. dyspnea
29. dyspnea
30. edema
31. edema
32. fatigue
33. fatigue
34. fever
35. fever
36. headache
37. headache
38. hepatitis B exacerbation
39. hyperglycemia
40. hyperglycemia
41. hypertension
42. hypertension
43. hypocalcemia
44. hypocalcemia
45. hypokalemia
46. hypokalemia
47. hypotension
48. hypoxia
49. infection
50. infection
51. influenza
52. infusion-related reactions
53. infusion-related reactions
54. insomnia
55. insomnia
56. laryngeal edema
57. laryngitis
58. leukopenia
59. leukopenia
60. lymphopenia
61. lymphopenia
62. muscle cramps
63. muscle cramps
64. musculoskeletal pain
65. musculoskeletal pain
66. nasal congestion
67. nausea
68. nausea
69. neutropenia
70. neutropenia
71. paresthesias
72. peripheral edema
73. peripheral edema
74. peripheral neuropathy
75. peripheral neuropathy
76. pharyngitis
77. pruritus
78. pulmonary edema
79. rhinitis
80. sinusitis
81. throat irritation
82. thrombocytopenia
83. thrombocytopenia
84. tracheitis
85. tremor
86. tremor
87. vomiting
88. vomiting
89. wheezing

Monitoring Parameters

• CBC with differential
• hepatitis B serology

Contraindications

• breast-feeding
• chronic obstructive pulmonary disease (COPD)
• contraception requirements
• hepatitis B exacerbation
• infection
• infusion-related reactions
• laboratory test interference
• neutropenia
• pregnancy
• reproductive risk
• thrombocytopenia
• vaccination

Interactions

• Palifermin
• Penicillamine
• Tuberculin Purified Protein Derivative, PPD

Palifermin: (Moderate) Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents. 

Penicillamine: (Major) Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity. 

Tuberculin Purified Protein Derivative, PPD: (Moderate) Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Consider deferring the skin test until completion of the immunosuppressive therapy.