Pomalidomide

Pomalidomide Brand Name– POMALYST

What is Pomalidomide

Pomalidomide is a structural analog of thalidomide that has immunomodulatory, antiangiogenic, and antineoplastic properties.

It is indicated for the treatment of multiple myeloma in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Additionally, pomalidomide is indicated in adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.

Pomalidomide is contraindicated in pregnancy due to a risk for birth defects or embryo-fetal death.

All prescribers, pharmacists, and patients must be registered in the POMALYST REMS program to prescribe, dispense, or receive pomalidomide.

Routine pregnancy testing is required for females of reproductive capacity. Information about the drug and the program can be found at www.celgeneriskmanagement.com or by calling 1-888-423-5436

Indications

• Kaposi’s sarcoma
• multiple myeloma

For the treatment of multiple myeloma

The FDA has designated pomalidomide as an orphan drug for the treatment of multiple myeloma.

for the treatment of multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor and who had disease progression within 60 days of completing the last therapy, in combination with dexamethasone

Side Effects

1. abdominal pain
2. anaphylactoid reactions
3. anemia
4. anemia
5. angina
6. angioedema
7. anorexia
8. anorexia
9. anxiety
10. arthralgia
11. arthralgia
12. asthenia
13. asthenia
14. atrial fibrillation
15. back pain
16. back pain
17. bone fractures
18. bone pain
19. bone pain
20. bronchospasm
21. chills
22. confusion
23. confusion
24. constipation
25. constipation
26. cough
27. cough
28. dehydration
29. dehydration
30. diarrhea
31. diarrhea
32. dizziness
33. dizziness
34. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
35. dyspnea
36. dyspnea
37. elevated hepatic enzymes
38. elevated hepatic enzymes
39. epistaxis
40. fatigue
41. fatigue
42. fetal death
43. fever
44. fever
45. GI bleeding
46. headache
47. headache
48. heart failure
49. hepatic failure
50. hepatitis
51. hepatitis B exacerbation
52. hyperbilirubinemia
53. hypercalcemia
54. hypercalcemia
55. hyperglycemia
56. hyperglycemia
57. hyperhidrosis
58. hyperkalemia
59. hyperthyroidism
60. hypoalbuminemia
61. hypocalcemia
62. hypocalcemia
63. hypokalemia
64. hypokalemia
65. hypomagnesemia
66. hyponatremia
67. hyponatremia
68. hypophosphatemia
69. hypophosphatemia
70. hypotension
71. hypothyroidism
72. infection
73. infection
74. insomnia
75. interstitial lung disease
76. interstitial nephritis
77. leukopenia
78. leukopenia
79. lymphadenopathy
80. lymphopenia
81. lymphopenia
82. maculopapular rash
83. maculopapular rash
84. muscle cramps
85. muscle cramps
86. musculoskeletal pain
87. musculoskeletal pain
88. myocardial infarction
89. myocarditis
90. nausea
91. nausea
92. nephrotoxicity
93. neutropenia
94. neutropenia
95. new primary malignancy
96. night sweats
97. organ transplant rejection
98. pancytopenia
99. pelvic pain
100. pelvic pain
101. pericarditis
102. peripheral edema
103. peripheral edema
104. peripheral neuropathy
105. peripheral neuropathy
106. pneumonitis
107. pruritus
108. pulmonary embolism
109. rash
110. rash
111. renal failure (unspecified)
112. skin cancer
113. Stevens-Johnson syndrome
114. stroke
115. syncope
116. teratogenesis
117. thrombocytopenia
118. thrombocytopenia
119. thromboembolism
120. thrombosis
121. toxic epidermal necrolysis
122. tremor
123. tremor
124. tumor lysis syndrome (TLS)
125. urinary retention
126. urticaria
127. vertigo
128. vomiting
129. vomiting
130. weakness
131. weakness
132. weight gain
133. weight loss
134. xerosis

Monitoring Parameters

• CBC with differential
• LFTs
• pregnancy testing
• serum creatinine/BUN
• serum electrolytes
• serum uric acid

Contraindications

• anemia
• angioedema
• blood donation
• breast-feeding
• contraception requirements
• dysfunctional uterine bleeding
• hepatic disease
• hepatotoxicity
• hyperlipidemia
• hypertension
• infertility
• intrauterine fetal death
• male-mediated teratogenicity
• menstrual irregularity
• myocardial infarction
• neutropenia
• pregnancy
• pregnancy testing
• renal disease
• renal failure
• renal impairment
• reproductive risk
• serious rash
• sperm donation
• stroke
• thalidomide hypersensitivity
• thrombocytopenia
• thromboembolism
• tobacco smoking
• treatment outside of a clinical trial
• tumor lysis syndrome (TLS)

Interactions

• Acetaminophen; Butalbital
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Amobarbital
• Aspirin, ASA; Butalbital; Caffeine
• Aspirin, ASA; Butalbital; Caffeine; Codeine
• Atropine; Hyoscyamine; Phenobarbital; Scopolamine
• Barbiturates
• Belladonna Alkaloids; Ergotamine; Phenobarbital
• Butabarbital
• Carbamazepine
• Ciprofloxacin
• Clozapine
• Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
• Deferasirox
• Denosumab
• Fluvoxamine
• Fosphenytoin
• grapefruit juice
• Isoniazid, INH; Pyrazinamide, PZA; Rifampin
• Isoniazid, INH; Rifampin
• Ketoconazole
• Lopinavir; Ritonavir
• Mephobarbital
• Methohexital
• Mexiletine
• Ombitasvir; Paritaprevir; Ritonavir
• Pentobarbital
• Phenobarbital
• Phenytoin
• Primidone
• Quinine
• Rifampin
• Ritonavir
• Secobarbital
• St. John’s Wort, Hypericum perforatum
• Thiabendazole
• Thiopental
• tobacco
• Zileuton