Ivosidenib

Ivosidenib Brand Name– TIBSOVO

What is Ivosidenib

Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

Patients with newly-diagnosed AML may receive ivosidenib if they are older than 75 years old or have comorbidities that preclude the use of intensive induction chemotherapy.

Ivosidenib targets mutant IDH1 variants resulting in increased myeloid differentiation and mature myeloid cell counts in IDH1-mutated AML. Differentiation syndrome has been reported with ivosidenib; this syndrome can be fatal if untreated.

Corticosteroid therapy and hemodynamic monitoring are indicated if differentiation syndrome is suspected. Prolongation of the QTc interval has also occurred in patients treated with ivosidenib.

Monitor ECGs and electrolytes, correcting any abnormalities as clinically appropriate

Indications

• acute myelogenous leukemia (AML)

For the treatment of acute myelogenous leukemia (AML)

NOTE: The FDA has designated ivosidenib as an orphan drug for the treatment of AML.

Side Effects

1. abdominal pain
2. abdominal pain
3. acneiform rash
4. anemia
5. anemia
6. angina
7. anorexia
8. anorexia
9. arthralgia
10. arthralgia
11. asthenia
12. asthenia
13. ataxia
14. back pain
15. chest pain (unspecified)
16. chest pain (unspecified)
17. constipation
18. constipation
19. cough
20. cough
21. diarrhea
22. diarrhea
23. differentiation syndrome
24. differentiation syndrome
25. dizziness
26. dyspepsia
27. dyspnea
28. dyspnea
29. edema
30. edema
31. elevated hepatic enzymes
32. elevated hepatic enzymes
33. encephalopathy
34. erythema
35. esophagitis
36. exfoliative dermatitis
37. fatigue
38. fatigue
39. fever
40. fever
41. fluid retention
42. gingivitis
43. Guillain-Barre syndrome
44. headache
45. hyperbilirubinemia
46. hyperbilirubinemia
47. hyperuricemia
48. hyperuricemia
49. hypervolemia
50. hypocalcemia
51. hypocalcemia
52. hypokalemia
53. hypokalemia
54. hypomagnesemia
55. hyponatremia
56. hyponatremia
57. hypophosphatemia
58. hypophosphatemia
59. hypotension
60. hypotension
61. hypoxia
62. leukocytosis
63. leukocytosis
64. maculopapular rash
65. musculoskeletal pain
66. myalgia
67. myalgia
68. nausea
69. nausea
70. nephrotoxicity
71. oral ulceration
72. paresthesias
73. pericardial effusion
74. peripheral edema
75. peripheral neuropathy
76. peripheral neuropathy
77. pleural effusion
78. pneumonitis
79. progressive multifocal leukoencephalopathy
80. pruritus
81. pruritus
82. pulmonary edema
83. QT prolongation
84. QT prolongation
85. rash
86. rash
87. skin ulcer
88. stomatitis
89. stomatitis
90. tumor lysis syndrome (TLS)
91. tumor lysis syndrome (TLS)
92. urticaria
93. ventricular fibrillation
94. vomiting
95. vomiting
96. weakness
97. weight loss

Monitoring Parameters

• CBC with differential
• creatine phosphokinase (CPK)
• ECG
• LFTs
• serum creatinine/BUN
• serum electrolytes
• serum uric acid

Contraindications

• apheresis
• AV block
• bradycardia
• breast-feeding
• cardiomyopathy
• celiac disease
• contraception requirements
• dialysis
• differentiation syndrome
• electrolyte imbalance
• females
• fever
• geriatric
• Guillain-Barre syndrome
• heart failure
• hepatic disease
• human immunodeficiency virus (HIV) infection
• hyperparathyroidism
• hypocalcemia
• hypokalemia
• hypomagnesemia
• hypothermia
• hypothyroidism
• infertility
• leukocytosis
• long QT syndrome
• myocardial infarction
• pericardial effusion
• peripheral edema
• pheochromocytoma
• pleural effusion
• pregnancy
• QT prolongation
• renal disease
• renal impairment
• reproductive risk
• rheumatoid arthritis
• sickle cell disease
• sleep deprivation
• stroke
• systemic lupus erythematosus (SLE)
• tumor lysis syndrome (TLS)

Interactions

• Acalabrutinib
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