Idelalisib

Idelalisib Brand Name– ZYDELIG

What is Idelalisib

Idelalisib is a phosphatidylinositol 3-kinase inhibitor.

It is indicated in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia (CLL) and as a single-agent for the treatment of relapsed B-cell follicular lymphoma (FL) or relapsed small lymphocytic lymphoma in patients who have received at least 2 prior systemic therapies.

It should not be used as first-line treatment of CLL or FL; additionally, idelalisib is not recommended for use in combination with bendamustine and/or rituximab for the treatment of FL.

Increased rates of adverse events, including death, were reported in patients who received idelalisib in combination with other cancer therapy in 6 clinical trials; these trials were stopped early.

Fatal and/or serious toxicities including hepatotoxicity, diarrhea or colitis, pneumonitis, infection, and intestinal perforation have been reported with idelalisib therapy.

Routine liver monitoring, for example, is required as part of the Zydelig REMs program. Information is available at www.ZydeligREMs.com

Indications

  • chronic lymphocytic leukemia (CLL)
  • non-Hodgkin’s lymphoma (NHL)

For the treatment of chronic lymphocytic leukemia (CLL)

NOTE: The FDA has designated idelalisib as an orphan drug for the treatment of CLL.

Side Effects

  1. abdominal pain
  2. abdominal pain
  3. anaphylactoid reactions
  4. anemia
  5. anemia
  6. anorexia
  7. anorexia
  8. arthralgia
  9. arthralgia
  10. asthenia
  11. asthenia
  12. chills
  13. chills
  14. colitis
  15. colitis
  16. cough
  17. cough
  18. dehydration
  19. dehydration
  20. diarrhea
  21. diarrhea
  22. dyspnea
  23. dyspnea
  24. elevated hepatic enzymes
  25. elevated hepatic enzymes
  26. enterocolitis
  27. exfoliative dermatitis
  28. fatigue
  29. fatigue
  30. fever
  31. fever
  32. gastroesophageal reflux
  33. gastroesophageal reflux
  34. GI perforation
  35. headache
  36. headache
  37. hepatotoxicity
  38. hypoxia
  39. infection
  40. infection
  41. insomnia
  42. lethargy
  43. leukopenia
  44. leukopenia
  45. lymphocytosis
  46. lymphopenia
  47. lymphopenia
  48. maculopapular rash
  49. maculopapular rash
  50. nausea
  51. nausea
  52. neutropenia
  53. neutropenia
  54. night sweats
  55. peripheral edema
  56. peripheral edema
  57. pneumonitis
  58. rash
  59. rash
  60. sinusitis
  61. Stevens-Johnson syndrome
  62. stomatitis
  63. stomatitis
  64. thrombocytopenia
  65. thrombocytopenia
  66. toxic epidermal necrolysis
  67. vomiting
  68. vomiting

Monitoring Parameters

  • CBC with differential
  • LFTs
  • pregnancy testing

Contraindications

  • abdominal pain
  • breast-feeding
  • colitis
  • contraception requirements
  • diarrhea
  • geriatric
  • GI perforation
  • hepatic disease
  • hepatotoxicity
  • infection
  • infertility
  • male-mediated teratogenicity
  • nausea/vomiting
  • neutropenia
  • pneumonitis
  • pregnancy
  • pregnancy testing
  • reproductive risk
  • serious rash

Interactions

  • Abacavir; Dolutegravir; Lamivudine
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