Pomalidomide
Generic: POMALIDOMIDE
Basic Information
Manufacturer
Camber Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
52676691-e171-467c-ae55-b5dcc14062a4
Indications & Usage
1 INDICATIONS AND USAGE Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: • in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ).
1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: • Embryo-Fetal Toxicity [see Warnings and Precautions (5.1, 5.2) ] • Venous and Arterial Thromboembolism [see Warnings and Precautions ( 5.3 )] • Increased Mortality in Patients with Multiple Myeloma When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions ( 5.4 )] • Hematologic Toxicity [see Warnings and Precautions ( 5.5 )] • Hepatotoxicity [see Warnings and Precautions ( 5.6 )] • Severe Cutaneous Reactions [see Warnings and Precautions ( 5.7 )] • Dizziness and Confusional State [see Warnings and Precautions ( 5.8 )] • Neuropathy [see Warnings and Precautions ( 5.9)] • Risk of Second Primary Malignancies [see Warnings and Precautions ( 5.10 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.11 )] • Hypersensitivity [see Warnings and Precautions (5.12) ] • MM: Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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.
Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (112 patients) or pomalidomide 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 pomalidomide + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients).
The median number of treatment cycles for the pomalidomide + Low-dose Dex arm was 5.
In the pomalidomide + Low-dose Dex arm, 67% of patients had a dose interruption of pomalidomide, the median time to the first dose interruption of pomalidomide was 4.1 weeks.
Twenty-seven percent of patients had a dose reduction of pomalidomide, the median time to the first dose reduction of pomalidomide was 4.5 weeks.
Eight percent of patients discontinued pomalidomide due to adverse reactions.
Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.
Table 3: Adverse Reactions in Any Pomalidomide Treatment Arm in Trial 1* *Regardless of attribution of relatedness to pomalidomide.
a Pomalidomide 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.
b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm.
Data cutoff: 01 March 2013 Table 4: Adverse Reactions in Trial 2 a Percentage did not meet the criteria to be considered as an adverse reaction for pomalidomide 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 pomalidomide in patients with MM, 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 table3 table4 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of pomalidomide.
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.
Blood and Lymphatic System Disorders: Pancytopenia Endocrine Disorders: Hypothyroidism, hyperthyroidism Gastrointestinal Disorders: Gastrointestinal hemorrhage Hepatobiliary Disorders: Hepatic failure (including fatal cases), elevated liver enzymes Immune system Disorders: Allergic reactions (e.g., angioedema, anaphylaxis, urticaria), solid organ transplant rejection Infections and Infestations: Hepatitis B virus reactivation, Herpes zoster, progressive multifocal leukoencephalopathy (PML) Neoplasms benign, malignant and unspecified (incl cysts and polyps): Tumor lysis syndrome, basal cell carcinoma, and squamous cell carcinoma of the skin Skin and Subcutaneous Tissue Disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)
To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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.
Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (112 patients) or pomalidomide 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 pomalidomide + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients).
The median number of treatment cycles for the pomalidomide + Low-dose Dex arm was 5.
In the pomalidomide + Low-dose Dex arm, 67% of patients had a dose interruption of pomalidomide, the median time to the first dose interruption of pomalidomide was 4.1 weeks.
Twenty-seven percent of patients had a dose reduction of pomalidomide, the median time to the first dose reduction of pomalidomide was 4.5 weeks.
Eight percent of patients discontinued pomalidomide due to adverse reactions.
Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.
Table 3: Adverse Reactions in Any Pomalidomide Treatment Arm in Trial 1* *Regardless of attribution of relatedness to pomalidomide.
a Pomalidomide 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.
b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm.
Data cutoff: 01 March 2013 Table 4: Adverse Reactions in Trial 2 a Percentage did not meet the criteria to be considered as an adverse reaction for pomalidomide 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 pomalidomide in patients with MM, 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 table3 table4 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of pomalidomide.
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.
Blood and Lymphatic System Disorders: Pancytopenia Endocrine Disorders: Hypothyroidism, hyperthyroidism Gastrointestinal Disorders: Gastrointestinal hemorrhage Hepatobiliary Disorders: Hepatic failure (including fatal cases), elevated liver enzymes Immune system Disorders: Allergic reactions (e.g., angioedema, anaphylaxis, urticaria), solid organ transplant rejection Infections and Infestations: Hepatitis B virus reactivation, Herpes zoster, progressive multifocal leukoencephalopathy (PML) Neoplasms benign, malignant and unspecified (incl cysts and polyps): Tumor lysis syndrome, basal cell carcinoma, and squamous cell carcinoma of the skin Skin and Subcutaneous Tissue Disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)