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Pomalyst

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Pomalyst

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:

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) »

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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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