Tisagenlecleucel

What is Tisagenlecleucel

Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell therapy and the first gene therapy approved by the FDA. 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.

Tisagenlecleucel is indicated for use in patients up to 25 years of age with relapsed or refractory B-cell precursor acute lymphoblastic leukemia and in adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

It is not indicated for use in patients with primary central nervous system lymphoma.

Cytokine release syndrome and severe neurotoxicity have been reported.

Tisagenlecleucel is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.

Brand Name

KYMRIAH

Indications

  • acute lymphocytic leukemia (ALL)
  • non-Hodgkin’s lymphoma (NHL)

Side Effects

  1. abdominal pain
  2. acute respiratory distress syndrome (ARDS)
  3. agitation
  4. anemia
  5. anorexia
  6. antibody formation
  7. anuria
  8. anxiety
  9. aphasia
  10. arthralgia
  11. asthenia
  12. ataxia
  13. atrial fibrillation
  14. azotemia
  15. back pain
  16. blurred vision
  17. capillary leak syndrome
  18. cardiac arrest
  19. chills
  20. coagulopathy
  21. confusion
  22. constipation
  23. contact dermatitis
  24. cough
  25. cytokine release syndrome
  26. delirium
  27. diarrhea
  28. disseminated intravascular coagulation (DIC)
  29. dizziness
  30. drowsiness
  31. dysarthria
  32. dyspnea
  33. edema
  34. elevated hepatic enzymes
  35. encephalopathy
  36. fatigue
  37. fecal incontinence
  38. fever
  39. graft-versus-host disease (GVHD)
  40. hallucinations
  41. headache
  42. heart failure
  43. hyperbilirubinemia
  44. hyperesthesia
  45. hypertension
  46. hypoesthesia
  47. hypokalemia
  48. hyponatremia
  49. hypophosphatemia
  50. hypotension
  51. hypoxia
  52. impaired cognition
  53. infection
  54. insomnia
  55. intracranial bleeding
  56. irritability
  57. lethargy
  58. leukopenia
  59. lymphopenia
  60. maculopapular rash
  61. malaise
  62. memory impairment
  63. migraine
  64. muscle cramps
  65. myalgia
  66. myopathy
  67. nasal congestion
  68. nausea
  69. nephrotoxicity
  70. neurotoxicity
  71. neutropenia
  72. nightmares
  73. pancytopenia
  74. paresthesias
  75. peripheral edema
  76. peripheral neuropathy
  77. pleural effusion
  78. prolonged bleeding time
  79. pulmonary edema
  80. pulmonary embolism
  81. rash
  82. renal failure (unspecified)
  83. renal tubular necrosis
  84. respiratory depression
  85. restlessness
  86. seizures
  87. sinus tachycardia
  88. stroke
  89. supraventricular tachycardia (SVT)
  90. syncope
  91. tachypnea
  92. thrombocytopenia
  93. thrombosis
  94. tremor
  95. tumor lysis syndrome (TLS)
  96. visual impairment
  97. vomiting
  98. weight loss

Monitoring Parameters

  • CBC with differential
  • hepatitis B serology
  • neurologic function
  • plasma hepatitis C RNA
  • plasma HIV RNA
  • pregnancy testing
  • serum creatinine/BUN
  • serum electrolytes
  • serum IgG concentations
  • serum uric acid

Contraindications

  • blood donation
  • breast-feeding
  • contraception requirements
  • cytokine release syndrome
  • driving or operating machinery
  • encephalopathy
  • fungal infection
  • hepatitis
  • hepatitis B exacerbation
  • hypogammaglobulinemia
  • infection
  • infusion-related reactions
  • laboratory test interference
  • neonates
  • neurotoxicity
  • neutropenia
  • new primary malignancy
  • pregnancy
  • pregnancy testing
  • reproductive risk
  • requires a specialized care setting
  • requires an experienced clinician
  • seizures
  • thrombocytopenia
  • tumor lysis syndrome (TLS)
  • vaccination
  • viral infection

Interactions

  • Live Vaccines
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