Axicabtagene Ciloleucel

Axicabtagene Ciloleucel Brand Name– YESCARTA

What is Axicabtagene Ciloleucel

Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell gene therapy.

It is CD19-directed immunotherapy that works by using a patient’s own genetically altered immune cells to kill B-cell cancer cells in the blood.

Axicabtagene ciloleucel is indicated for use in adult patients with relapsed or refractory large B-cell lymphoma (e.g., diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) after 2 or more lines of systemic therapy.

It is not indicated for the treatment of patients with primary central nervous system lymphoma. Cytokine release syndrome and severe neurotoxicity have been reported.

Axicabtagene ciloleucel is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS. Information for this program enrollment is available at www.YescartaREMS.com or 1-844-454-5483.

Indications

• non-Hodgkin’s lymphoma (NHL)

For the treatment of non-Hodgkin’s lymphoma (NHL)

NOTE: Axicabtagene ciloleucel has been designated an orphan drug by the FDA.

for the treatment of relapsed or refractory large B-cell lymphoma (e.g., diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) following 2 or more lines of systemic therapy

Side Effects

1. abdominal pain
2. anaphylactoid reactions
3. anemia
4. anorexia
5. antibody formation
6. anxiety
7. aphasia
8. arthralgia
9. ataxia
10. atrial fibrillation
11. atrial flutter
12. AV block
13. back pain
14. bundle-branch block
15. capillary leak syndrome
16. cardiac arrest
17. chills
18. coagulopathy
19. confusion
20. constipation
21. cough
22. cytokine release syndrome
23. dehydration
24. delirium
25. diarrhea
26. dizziness
27. drowsiness
28. dyspnea
29. edema
30. elevated hepatic enzymes
31. encephalopathy
32. fatigue
33. fever
34. hallucinations
35. headache
36. heart failure
37. hyperactivity
38. hyperbilirubinemia
39. hypertension
40. hyperuricemia
41. hypokalemia
42. hyponatremia
43. hypophosphatemia
44. hypotension
45. hypoxia
46. infection
47. insomnia
48. irritability
49. leukoencephalopathy
50. leukopenia
51. lymphopenia
52. macrophage activation syndrome
53. malaise
54. memory impairment
55. muscle cramps
56. myoclonia
57. nausea
58. nephrotoxicity
59. neurotoxicity
60. neutropenia
61. orthostatic hypotension
62. paranoia
63. peripheral edema
64. pleural effusion
65. pulmonary edema
66. pulmonary embolism
67. QT prolongation
68. rash
69. respiratory arrest
70. restlessness
71. seizures
72. sinus tachycardia
73. supraventricular tachycardia (SVT)
74. syncope
75. thrombocytopenia
76. thromboembolism
77. thrombosis
78. tremor
79. ventricular tachycardia
80. vomiting
81. weakness
82. weight loss
83. xerostomia

Monitoring Parameters

• CBC with differential
• hepatitis B serology
• neurologic function
• plasma hepatitis C RNA
• plasma HIV RNA
• pregnancy testing
• serum IgG concentations

Contraindications

• aminoglycoside hypersensitivity
• anemia
• blood donation
• breast-feeding
• contraception requirements
• cytokine release syndrome
• driving or operating machinery
• encephalopathy
• fungal infection
• hepatitis
• hepatitis B exacerbation
• hypogammaglobulinemia
• infection
• mental status changes
• neurotoxicity
• neutropenia
• new primary malignancy
• pregnancy
• pregnancy testing
• reproductive risk
• requires a specialized care setting
• requires an experienced clinician
• seizures
• thrombocytopenia
• vaccination
• viral infection

Interactions

• Live Vaccines