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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:

Clinical Trials Experience

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with POMALYST + Low-dose Dex (112 patients) or POMALYST alone (107 patients). Median number of treatment cycles was 5. Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions. Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to adverse reactions was 11%.

In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with POMALYST + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients). The median number of treatment cycles for the POMALYST + Low-dose Dex arm was 5. In the POMALYST + Low-dose Dex arm, 67% of patients had a dose interruption of POMALYST, the median time to the first dose interruption of POMALYST was 4.1 weeks. Twenty-seven percent of patients had a dose reduction of POMALYST, the median time to the first dose reduction of POMALYST was 4.5 weeks. Eight percent of patients discontinued POMALYST due to adverse reactions.

Tables 2 and 3 summarize the adverse reactions reported in Trials 1 and 2, respectively.

Table 2: Adverse Reactions in Any POMALYST Treatment Arm in Trial 1*

System Organ Class/
Preferred Term
All Adverse Reactions ≥ 10% in Either Arm Grade 3 or 4 ≥ 5% in Either Arm
POMALYSTa
(N=107)
POMALYST + Low-dose Dex
(N=112)
POMALYST
(N=107)
POMALYST + Low-dose Dex
(N=112)
Number (%) of patients with at least one adverse reaction 107 (100) 112 (100) 98 (91.6) 102 (91.1)
Blood and lymphatic system disorders
  Neutropeniab 57 (53.3) 55 (49.1) 51 (47.7) 46 (41.1)
  Anemiab 41 (38.3) 47 (42.0) 25 (23.4) 24 (21.4)
  Thrombocytopeniab 28 (26.2) 26 (23.2) 24 (22.4) 21 (18.8)
  Leukopenia 14 (13.1) 22 (19.6) 7 (6.5) 11 (9.8)
  Febrile neutropeniab < 10% < 10% 6 (5.6) 3 (2.7)
  Lymphopenia 4 (3.7) 17 (15.2) 2 (1.9) 8 (7.1)
General disorders and administration site conditions
  Fatigue and astheniab 62 (57.9) 70 (62.5) 13 (12.1) 19 (17.0)
  Edema peripheral 27 (25.2) 19 (17.0) 0 (0.0) 0 (0.0)
  Pyrexiab 25 (23.4) 36 (32.1) < 5% < 5%
  Chills 11 (10.3) 14 (12.5) 0 (0.0) 0 (0.0)
Gastrointestinal disorders
  Constipationb 38 (35.5) 41 (36.6) < 5% < 5%
  Diarrhea 37 (34.6) 40 (35.7) < 5% < 5%
  Vomitingb 15 (14.0) 16 (14.3) < 5% 0 (0.0)
Musculoskeletal and connective tissue disorders
  Back painb 37 (34.6) 36 (32.1) 15 (14.0) 11 (9.8)
  Musculoskeletal chest pain 25 (23.4) 22 (19.6) < 5% 0 (0.0)
  Muscle spasms 23 (21.5) 22 (19.6) < 5% < 5%
  Arthralgia 18 (16.8) 17 (15.2) < 5% < 5%
  Muscular weakness 15 (14.0) 15 (13.4) 6 (5.6) 4 (3.6)
  Bone pain 13 (12.1) 8 (7.1) < 5% < 5%
  Musculoskeletal pain 13 (12.1) 19 (17.0) < 5% < 5%
  Pain in extremity 8 (7.5) 16 (14.3) 0 (0.0) < 5%
Infections and infestations
  Upper respiratory tract infection 40 (37.4) 32 (28.6) < 5% < 5%
  Pneumoniab 30 (28.0) 38 (33.9) 21 (19.6) 32 (28.6)
  Urinary tract infectionb 11 (10.3) 19 (17.0) 2 (1.9) 10 (8.9)
  Sepsisb < 10% < 10% 6 (5.6) 5 (4.5)
Metabolism and nutrition disorders
  Decreased appetite 25 (23.4) 21 (18.8) < 5% 0 (0.0)
  Hypercalcemiab 23 (21.5) 13 (11.6) 11 (10.3) 1 (0.9)
  Hypokalemia 13 (12.1) 13 (11.6) < 5% < 5%
  Hyperglycemia 12 (11.2) 17 (15.2) < 5% < 5%
  Hyponatremia 12 (11.2) 14 (12.5) < 5% < 5%
  Dehydrationb < 10% < 10% 5 (4.7) 6 (5.4)
  Hypocalcemia 6 (5.6) 13 (11.6) 0 (0.0) < 5%
Respiratory, thoracic and mediastinal disorders
  Dyspneab 38 (35.5) 50 (44.6) 8 (7.5) 14 (12.5)
  Cough 18 (16.8) 25 (22.3) 0 (0.0) 0 (0.0)
  Epistaxis 18 (16.8) 12 (10.7) < 5% 0 (0.0)
  Productive cough 10 (9.3) 14 (12.5) 0 (0.0) 0 (0.0)
  Oropharyngeal pain 6 (5.6) 12 (10.7) 0 (0.0) 0 (0.0)
Nervous system disorders
  Dizziness 24 (22.4) 20 (17.9) < 5% < 5%
  Peripheral neuropathy 23 (21.5) 20 (17.9) 0 (0.0) 0 (0.0)
  Headache 16 (15.0) 15 (13.4) 0 (0.0) < 5%
  Tremor 11 (10.3) 15 (13.4) 0 (0.0) 0 (0.0)
Skin and subcutaneous tissue disorders
  Rash 22 (20.6) 18 (16.1) 0 (0.0) < 5%
  Pruritus 16 (15.0) 10 (8.9) 0 (0.0) 0 (0.0)
  Dry skin 10 (9.3) 12 (10.7) 0 (0.0) 0 (0.0)
  Hyperhidrosis 8 (7.5) 18 (16.1) 0 (0.0) 0 (0.0)
  Night sweats 5 (4.7) 14 (12.5) 0 (0.0) 0 (0.0)
Investigations
  Blood creatinine increasedb 20 (18.7) 11 (9.8) 6 (5.6) 3 (2.7)
  Weight decreased 16 (15.0) 10 (8.9) 0 (0.0) 0 (0.0)
  Weight increased 1 (0.9) 12 (10.7) 0 (0.0) 0 (0.0)
Psychiatric disorders
  Anxiety 14 (13.1) 8 (7.1) 0 (0.0) 0 (0.0)
  Confusional stateb 13 (12.1) 15 (13.4) 6 (5.6) 3 (2.7)
  Insomnia 7 (6.5) 18 (16.1) 0 (0.0) 0 (0.0)
Renal and urinary disorders
  Renal failureb 16 (15.0) 11 (9.8) 9 (8.4) 8 (7.1)
* Regardless of attribution of relatedness to POMALYST.
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.
b Serious adverse reactions were reported in at least 2 patients in any POMALYST treatment arm.
Data cutoff: 01 March 2013

Table 3: Adverse Reactions in Trial 2

System Organ Class/
Preferred Term
All Adverse Reactions
( ≥ 5% in POMALYST + Low-dose Dex arm, and at least 2% point higher than the High-dose-Dex arm)
Grade 3 or 4
( ≥ 1% in POMALYST + Low-dose Dex arm, and at least 1% point higher than the High-dose-Dex arm)
POMALYST + Low-dose Dex
(N=300)
High-dose Dex
(N=150)
POMALYST + Low-dose Dex
(N=300)
High-dose Dex
(N=150)
Number (%) of patients with at least one adverse reaction 297 (99.0) 149 (99.3) 259 (86.3) 127 (84.7)
Blood and lymphatic system disorders
Neutropeniab 154 (51.3) 31 (20.7) 145 (48.3) 24 (16.0)
Thrombocytopenia 89 (29.7)a 44 (29.3)a 66 (22.0)a 39 (26.0)a
Leukopenia 38 (12.7) 8 (5.3) 27 (9.0) 5 (3.3)
Febrile neutropeniab 28 (9.3) 0 (0.0) 28 (9.3) 0 (0.0)
General disorders and administration site conditions
Fatigue and asthenia 140 (46.7) 64 (42.7) 26 (8.7) a 18 (12.0) a
Pyrexiab 80 (26.7) 35 (23.3) 9 (3.0)a 7 (4.7)a
Edema peripheral 52 (17.3) 17 (11.3) 4 (1.3) a 3 (2.0)a
Pain 11 (3.7) a 3 (2.0)a 5 (1.7) 1 (0.7)
Infections and infestations
Upper respiratory tract infectionb 93 (31.0) 19 (12.7) 9 (3.0) 1 (0.7)
Pneumoniab 58 (19.3) 20 (13.3) 47 (15.7) 15 (10.0)
Neutropenic sepsisb 3 (1.0)a 0 (0.0)a 3 (1.0) 0 (0.0)
Gastrointestinal disorders
Diarrhea 66 (22.0) 28 (18.7) 3 (1.0)a 2 (1.3) a
Constipation 65 (21.7) 22 (14.7) 7 (2.3) 0 (0.0)
Nausea 45 (15.0) 17 (11.3) 3 (1.0)a 2 (1.3) a
Vomiting 23 (7.7) 6 (4.0) 3 (1.0) 0 (0.0)
Musculoskeletal and connective tissue disorders
Back painb 59 (19.7) 24 (16.0) 15 (5.0) 6 (4.0)
Bone painb 54 (18.0) 21 (14.0) 22 (7.3) 7 (4.7)
Muscle spasms 46 (15.3) 11 (7.3) 1 (0.3)a 1 (0.7)a
Arthralgia 26 (8.7) 7 (4.7) 2 (0.7)a 1 (0.7)a
Pain in extremity 20 (6.7) a 9 (6.0)a 6 (2.0) 0 (0.0)
Respiratory, thoracic and mediastinal disorders
Dyspneab 76 (25.3) 25 (16.7) 17 (5.7) 7 (4.7)
Cough 60 (20.0) 15 (10.0) 2 (0.7)a 1 (0.7)a
Chronic obstructive pulmonary diseaseb 5 (1.7)a 0 (0.0)a 4 (1.3) 0 (0.0)
Nervous system disorders
Peripheral neuropathy 52 (17.3) 18 (12.0) 5 (1.7)a 2 (1.3) a
Dizziness 37 (12.3) 14 (9.3) 4 (1.3) a 2 (1.3) a
Headache 23 (7.7) 8 (5.3) 1 (0.3)a 0 (0.0)a
Tremor 17 (5.7) 2 (1.3) 2 (0.7)a 0 (0.0)a
Depressed level of consciousness 5 (1.7)a 0 (0.0)a 3 (1.0) 0 (0.0)
Metabolism and nutrition disorders
Decreased appetite 38 (12.7) 12 (8.0) 3 (1.0)a 2 (1.3) a
Hypokalemia 28 (9.3) a 12 (8.0) a 12 (4.0) 4 (2.7)
Hypocalcemia 12 (4.0) a 9 (6.0)a 5 (1.7) 1 (0.7)
Skin and subcutaneous tissue disorders
Rash 23 (7.7) 2 (1.3) 3 (1.0) 0 (0.0)
Pruritus 22 (7.3) 5 (3.3) 0 (0.0)a 0 (0.0)a
Hyperhidrosis 15 (5.0) 1 (0.7) 0 (0.0)a 0 (0.0)a
Investigations
Neutrophil count decreased 15 (5.0) 1 (0.7) 14 (4.7) 1 (0.7)
Platelet count decreased 10 (3.3) a 3 (2.0)a 8 (2.7) 2 (1.3)
White blood cell count decreased 8 (2.7)a 1 (0.7)a 8 (2.7) 0 (0.0)
Alanine aminotransferase increased 7 (2.3)a 2 (1.3) a 5 (1.7) 0 (0.0)
Aspartate aminotransferase increased 4 (1.3) a 2 (1.3) a 3 (1.0) 0 (0.0)
Lymphocyte count decreased 3 (1.0)a 1 (0.7)a 3 (1.0) 0 (0.0)
Renal and urinary disorders
Renal failure 31 (10.3) a 18 (12.0) a 19 (6.3) 8 (5.3)
Injury, poisoning and procedural complications
Femur fractureb 5 (1.7)a 1 (0.7)a 5 (1.7) 1 (0.7)
Reproductive system and breast disorders
Pelvic pain 6 (2.0)a 3 (2.0)a 4 (1.3) 0 (0.0)
a Percentage did not meet the criteria to be considered as an adverse reaction for POMALYST for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events).
b Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.
Data cutoff: 01 March 2013

Other Adverse Reactions

Other adverse reactions of POMALYST in patients with multiple myeloma, not described above, and considered important:

Cardiac disorders: Myocardial infarction, Atrial fibrillation, Angina pectoris, Cardiac failure congestive

Ear and labyrinth disorders: Vertigo

Gastrointestinal disorders: Abdominal pain

General disorders and administration site conditions: General physical health deterioration, Non-cardiac chest pain, Multi-organ failure

Hepatobiliary disorders: Hyperbilirubinemia

Infections and infestations: Pneumocystis jiroveci pneumonia, Respiratory syncytial virus infection, Neutropenic sepsis, Bacteremia, Pneumonia respiratory syncytial viral, Cellulitis, Urosepsis, Septic shock, Clostridium difficile colitis, Pneumonia streptococcal, Lobar pneumonia, Viral infection, Lung infection

Investigations: Alanine aminotransferase increased, Hemoglobin decreased

Injury, poisoning and procedural complications: Fall, Compression fracture, Spinal compression fracture

Metabolism and nutritional disorders: Hyperkalemia, Failure to thrive

Nervous System disorders: Depressed level of consciousness, Syncope

Psychiatric disorders: Mental status change

Renal and urinary disorders: Urinary retention, Hyponatremia

Reproductive system and breast disorders: Pelvic pain

Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, Pulmonary embolism, Respiratory failure, Bronchospasm

Vascular disorders: Hypotension

Postmarketing Experience

The following adverse drug reactions have been identified from the worldwide postmarketing experience with POMALYST: Pancytopenia, tumor lysis syndrome, allergic reactions (e.g., angioedema, urticaria), elevated liver enzymes, hepatic failure (including fatal cases).

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Pomalyst (Pomalidomide Capsules)

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