Pomalyst
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Pomalyst
Pomalyst Side Effects Center
Pharmacy Editor: Melissa Conrad Stöppler, MD
Pomalyst (pomalidomide) is an immunomodulatory drug used to treat patients with multiple myeloma, a type of cancer that affects white blood cells. Common side effects from the use of Pomalyst may include fatigue and weakness, low white blood cell count, anemia, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infections, back pain and fever.
Pomalyst should be started with a dose of 4 mg once daily, given orally. Pomalyst must be taken with water. Pomalyst should be swallowed whole and should not be broken, chewed or opened. Pomalyst should be taken without food. Interactions between Pomalyst and other drugs have not been studied. Because Pomalyst can cause harm to unborn babies when administered during pregnancy, women taking Pomalyst must not become pregnant. Women must produce two negative pregnancy tests and use contraception methods before beginning Pomalyst. Women must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with Pomalyst, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of Pomalyst therapy. Pomalyst is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 28 days after discontinuing Pomalyst, even if they have undergone a successful vasectomy. Male patients taking Pomalyst must not donate sperm. It is not known if Pomalyst is excreted in human milk. A decision should be made whether to breastfeed or take Pomalyst. A nursing mother should not do both.
Our Pomalyst (pomalidomide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pomalyst FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are described in detail in other labeling sections:
- Fetal Risk [see BOXED WARNINGS, WARNINGS AND PRECAUTIONS]
- Venous Thromboembolism [see BOXED WARNINGS, WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Dizziness and Confusional State [see WARNINGS AND PRECAUTIONS]
- Neuropathy [see WARNINGS AND PRECAUTIONS]
- Risk of Second Primary Malignancies [see WARNINGS AND PRECAUTIONS]
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 entire FDA prescribing information for Pomalyst (Pomalidomide Capsules) »
Additional Pomalyst Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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