erious Adverse Reactions Reported in 2 or more Patients [a] Pomalyst alone arm includes all patients randomized to the Pomalyst alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.
Trial 1
Pomalysta
(N = 107) Pomalyst +
Low dose Dex
(N=112)
System Organ Class/Preferred Term n (%) n (%)
Number(%) of Patients With at Least One Treatment
Emergent Serious Adverse Reaction 72 ( 67) 69 ( 62)
Infections and infestations
Pneumonia 15 (14) 21 (19)
Urinary tract infection 0 ( 0) 6 ( 5)
Sepsis 6 ( 6) 3 ( 3)
Respiratory, Thoracic and mediastinal disorders
Dyspnea 5 (5) 7 (6)
General disorders and administration site conditions
Pyrexia 3 (3) 5 (5)
General physical health deterioration 0 (0) 2 (2)
Cardiac Disorders
Atrial fibrillation 2 (2) 3 (3)
Cardiac failure congestive 0 (0) 3 (3)
Renal and urinary disorders
Renal failure 9 (8) 7 (6)
Gastrointestinal disorders
constipation 1 (1) 3 (3)
Blood and Lymphatic system disorders
Febrile neutropenia 5 (5) 1 (1)
Metabolism and nutrition disorders
Dehydration 5 (5) 3 (3)
Hypercalcemia 5 (5) 2 (2)
Musculoskeletal and connective tissue disorders
Back pain 4 (4) 2 (2)
Other Adverse Reactions
Other adverse reactions of Pomalyst in patients with multiple myeloma, not described above, and considered important:
Ear and Labyrinth Disorders: Vertigo
Hepatobiliary Disorders: Hyperbilirubinemia
Infections and Infestations: Pneumocystis jiroveci pneumonia, Respiratory syncytial virus infection, Neutropenic sepsis
Investigations: Alanine aminotransferase increased
Metabolism and Nutritional Disorders: Hyperkalemia
Renal and Urinary Disorders: Urinary retention
Reproductive System and Breast Disorders: Pelvic Pain
Respiratory, Thoracic and Mediastinal Disorders: Interstitial Lung Disease
Drug Interactions
No formal drug interaction studies have been conducted with Pomalyst. Pomalidomide is primarily metabolized by CYP1A2 and CYP3A. Pomalidomide is also a substrate for P-glycoprotein (P-gp).
Drugs That May Increase Pomalidomide Plasma Concentrations
CYP3A, CYP1A2 or P-gp inhibitors: Co-administration of Pomalyst with drugs that are strong inhibitors of CYP1A2, CYP3A (e.g. ketoconazole) or P-gp could increase exposure and should be avoided.
Drugs That May Decrease Pomalidomide Plasma Concentrations
CYP3A, CYP1A2 or P-gp inducers: Co-administration of Pomalyst with drugs that are strong inducers of CYP1A2, CYP3A (e.g. rifampin) or P-gp cou |
