Ixabepilone

Ixabepilone Brand Name– Ixempra

What is Ixabepilone

Ixabepilone (Ixempra™, BMS-247550) is the first FDA-approved epothilone antineoplastic agent. Epothilones are isolated from the myxobacterium Sorangium cellulosum.

Though structurally unrelated, both taxanes and epothilones including ixabepilone are microtubule stabilizing agents and have a similar mechanism of action.

Ixabepilone is a semisynthetic analog of epothilone B that is approved for use with capecitabine in the treatment of metastatic or locally advanced breast cancer that is resistant to an anthracycline and a taxane or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

Among patients with breast cancer that was pretreated or resistant to anthracyclines and resistant to taxanes, a longer median progression-free survival (5.8 months) was obtained among ixabepilone plus capecitabine recipients as compared with capecitabine monotherapy recipients (4.2 months); significant benefit of ixabepilone plus capecitabine therapy was maintained across predefined subgroups including HER2-/ER-/PR-.

Ixabepilone is also approved as monotherapy for the treatment of metastatic or locally advanced breast cancer that is resistant or refractory to anthracyclines, taxanes, and capecitabine.

Among 113 women whose tumors had recurred or progressed after at least 2 chemotherapy regimens that included an anthracycline, a taxane, and capecitabine, 12.4% had a partial objective response; the median response duration was 6 months.

Currently, there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed or whose disease is not responding to prior chemotherapy such as an anthracycline and a taxane.

Ixabepilone appears to have low susceptibility to various mechanisms involved in the development of tumor resistance to drug therapy.

Ixabepilone received FDA approval on October 16, 2007.

Indications

• breast cancer

For the treatment of breast cancer

NOTE: Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.³³⁵⁶³

for the treatment of metastatic or locally advanced breast cancer that is resistant to an anthracycline and a taxane, or that is taxane resistant and for patients whom further anthracycline therapy is contraindicated, in combination with capecitabine

Side Effects

1. abdominal pain
2. abdominal pain
3. alopecia
4. alopecia
5. anaphylactoid reactions
6. anemia
7. anemia
8. angina
9. anorexia
10. anorexia
11. arthralgia
12. arthralgia
13. asthenia
14. asthenia
15. atrial flutter
16. bleeding
17. bronchospasm
18. cardiomyopathy
19. chest pain (unspecified)
20. chest pain (unspecified)
21. chills
22. coagulopathy
23. colitis
24. constipation
25. constipation
26. cough
27. dehydration
28. dehydration
29. diarrhea
30. diarrhea
31. dizziness
32. dizziness
33. dysesthesia
34. dysesthesia
35. dysgeusia
36. dysphagia
37. dysphonia
38. dyspnea
39. dyspnea
40. edema
41. edema
42. elevated hepatic enzymes
43. enterocolitis
44. erythema multiforme
45. esophagitis
46. fatigue
47. fatigue
48. fever
49. fever
50. flushing
51. gastritis
52. gastroesophageal reflux
53. gastroesophageal reflux
54. GI bleeding
55. headache
56. headache
57. hepatic failure
58. hot flashes
59. hyperesthesia
60. hyperesthesia
61. hypoesthesia
62. hypoesthesia
63. hypokalemia
64. hyponatremia
65. hyporeflexia
66. hyporeflexia
67. hypotension
68. hypovolemia
69. hypoxia
70. infection
71. insomnia
72. insomnia
73. intracranial bleeding
74. jaundice
75. lacrimation
76. laryngitis
77. lethargy
78. leukopenia
79. leukopenia
80. lymphopenia
81. metabolic acidosis
82. musculoskeletal pain
83. musculoskeletal pain
84. myalgia
85. myalgia
86. myocardial infarction
87. nausea
88. nausea
89. neuritis
90. neuritis
91. neutropenia
92. neutropenia
93. palmar-plantar erythrodysesthesia (hand and foot syndrome)
94. palmar-plantar erythrodysesthesia (hand and foot syndrome)
95. paresthesias
96. paresthesias
97. peripheral neuropathy
98. peripheral neuropathy
99. pneumonitis
100. pruritus
101. pruritus
102. pulmonary edema
103. radiation recall reaction
104. rash
105. rash
106. skin hyperpigmentation
107. stomatitis
108. stomatitis
109. syncope
110. thrombocytopenia
111. thrombocytopenia
112. thromboembolism
113. thrombosis
114. trismus
115. vasculitis
116. vomiting
117. vomiting
118. weakness
119. weight loss

Monitoring Parameters

• CBC with differential
• LFTs
• platelet count
• serum bilirubin
• WBC

Contraindications

• alcoholism
• bone marrow suppression
• breast-feeding
• cardiac arrhythmias
• cardiac disease
• children
• diabetes mellitus
• driving or operating machinery
• geriatric
• hepatic disease
• jaundice
• neutropenia
• peripheral neuropathy
• polyoxyethylated castor oil hypersensitivity
• pregnancy
• radiation therapy
• substance abuse
• thrombocytopenia
• vaccination
• ventricular dysfunction

Interactions

• Acetaminophen; Butalbital
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Propoxyphene
• Alfentanil
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• Aspirin, ASA; Butalbital; Caffeine; Codeine
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• grapefruit juice
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