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Pomalyst

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Pomalyst

SIDE EFFECTS

The following adverse reactions are described in detail in other labeling sections:

Clinical Trials Experience in Multiple Myeloma

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trial 1, data were evaluated from 219 patients (safety population) who received treatment with POMALYST + Low Dose Dexamethasone (Low dose Dex) (112 patients) or POMALYST alone (107 patients). Median number of treatment cycles was 5. Sixty three percent of patients in the study had a dose interruption of either drug due to adverse reactions. Thirty seven percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to treatment-related adverse reaction was 3%.

Tables 2, 3 and 4 summarize all treatment-emergent adverse reactions reported for POMALYST + Low dose Dex and POMALYST alone groups regardless of attribution of relatedness to pomalidomide. In the absence of a randomized comparator arm, it is often not possible to distinguish adverse events that are drug-related and those that reflect the patient's underlying disease.

Table 2: Adverse Reactions Reported in 10% of Patients in Any Treatment Arm

System Organ Class/Preferred Term Trial 1
POMALYSTa
(N = 107)
n (%)
POMALYST + Low dose Dex
(N=112)
n (%)
Number(%) of Patients With at Least One Treatment Emergent Adverse Reaction 107 (100) 112 (100)
General disorders and administration site conditions
Fatigue and asthenia 59 (55) 70 (63)
Pyrexia 20 (19) 34 (30)
Edema peripheral 25 (23) 18 (16)
Chills 10 (9) 12 (11)
Pain 6 (6) 5 (5)
Blood and lymphatic system disorders
Neutropenia 56 (52) 53 (47)
Anemia 41 (38) 44 (39)
Thrombocytopenia 27 (25) 26 (23)
Leukopenia 12 (11) 20 (18)
Lymphopenia 4 (4) 17 (15)
Gastrointestinal disorders
Constipation 38 (36) 39 (35)
Diarrhea 36 (34) 37 (33)
Nausea 38 (36) 25 (22)
Vomiting 15 (14) 15 (13)
Infections and infestations
Pneumonia 25 (23) 32 (29)
Upper respiratory tract infection 34 (32) 28 (25)
Urinary tract infection 8 (8) 18 (16)
Musculoskeletal and connective tissue disorders
Back pain 34 (32) 34 (30)
Musculoskeletal chest pain 23 (22) 22 (20)
Muscle spasms 20 (19) 21 (19)
Arthralgia 17 (16) 17 (15)
Musculoskeletal pain 12 (11) 17 (15)
Pain in extremity 5 (5) 16 (14)
Muscular weakness 13 (12) 13 (12)
Bone pain 13 (12) 5 (5)
Respiratory, thoracic and mediastinal disorders
Dyspnea 36 (34) 50 (45)
Cough 15 (14) 23 (21)
Epistaxis 16 (15) 12 (11)
Metabolism and nutritional disorders
Decreased appetite 23 (22) 20 ( 18)
Hyperglycemia 13 ( 12) 17 ( 15)
Hyponatremia 11 ( 10) 14 ( 13)
Hypercalcemia 22 ( 21) 13 (12)
Hypocalcemia 6 (6) 13 ( 12)
Hypokalemia 11 ( 10) 12 ( 11)
Skin and subcutaneous tissue disorders
Hyperhidrosis 6 ( 6) 18 ( 16)
Rash 23 ( 22) 18 ( 16)
Night sweats 5 ( 5) 14 ( 13)
Dry skin 10 ( 9) 12 ( 11)
Pruritus 16 ( 15) 12 ( 11)
Nervous system disorders
Dizziness 21 ( 20) 19 ( 17)
Tremor 10 ( 9) 14 ( 13)
Headache 14 ( 13) 9 ( 8)
Neuropathy peripheral 11 ( 10) 8 ( 7)
Investigations
Blood creatinine increased 16 ( 15) 12 ( 11)
Weight increased 1 ( 1) 12 ( 11)
Weight decreased 15 ( 14) 9 ( 8)
Psychiatric disorders
Insomnia 7 ( 7) 16 ( 14)
Confusional state 11 ( 10) 15 ( 13)
Anxiety 12 ( 11) 8 ( 7)
Renal and urinary disorders
Renal failure 16 ( 15) 11 ( 10)
aPOMALYST alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period

Table 3: Grade 3/4 Adverse Reactions Reported in ≥ 5% of Patients in Any Treatment Arm

System Organ Class/Preferred Terma Trial 1
POMALYST + Low dose Dex
(N=112)
n (%)
POMALYSTa
(N = 107)
n (%)
Number(%) of Patients With at Least One Treatment Emergent NCI CTC Grade 3 or 4 Adverse Reaction 96 ( 90) 99 ( 88)
Blood and lymphatic system disorders
Neutropenia 50 ( 47) 43 ( 38)
Anemia 24 ( 22) 23 ( 21)
Thrombocytopenia 24 ( 22) 21 ( 19)
Leukopenia 6 ( 6) 11 ( 10)
Lymphopenia 2 ( 2) 8 ( 7)
Infections and infestations
Pneumonia 17 ( 16) 26 (23)
Urinary tract infection 2 ( 2) 9 ( 8)
Sepsis 6 ( 6) 3 ( 3)
Metabolism and nutritional disorders
Hypercalcemia 10 ( 9) 1 ( 1)
General disorders and administration site conditions
Fatigue and asthenia 12 ( 11) 14 ( 13)
Investigations
Blood creatinine increased 6 ( 6) 3 ( 3)
Respiratory, thoracic and mediastinal disorders
Dyspnea 7 ( 7) 14 ( 13)
Musculoskeletal and connective tissue disorders
Back pain 13 ( 12) 10 ( 9)
Muscular weakness 6 ( 6) 4 ( 4)
Renal and urinary disorders
Renal failure 10 ( 9) 7 ( 6)
aPOMALYST alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.

Table 4: Serious Adverse Reactions Reported in 2 or more Patients

System Organ Class/Preferred Term Trial 1
POMALYSTa
(N = 107)
n (%)
POMALYST+ Low dose Dex
(N=112)
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)
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.

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

Read the Pomalyst (pomalidomide capsules) Side Effects Center for a complete guide to possible side effects

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 could decrease exposure and should be avoided.

Smoking

Cigarette smoking may reduce pomalidomide exposure due to CYP1A2 induction. Patients should be advised that smoking may reduce the efficacy of pomalidomide.

Dexamethasone

Co-administration of multiple doses of 4 mg POMALYST with 20 mg to 40 mg dexamethasone (a weak inducer of CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.

Last reviewed on RxList: 2/21/2013
This monograph has been modified to include the generic and brand name in many instances.

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