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
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