ied with the Pomalyst REMS program, must only dispense to patients who are authorized to receive Pomalyst and comply with REMS requirements.
Further information about the Pomalyst REMS program is available at [celgeneriskmanagement.com] or by telephone at 1-888-423-5436.
Venous Thromboembolism
Patients receiving Pomalyst have developed venous thromboembolic events (Venous Thromboembolism [VTEs]) reported as serious adverse reactions. In the trial, all patients were required to receive prophylaxis or anti-thrombotic treatment; 81% used aspirin, 16% warfarin, 21% heparin, and 3% clopidogrel. The rate of deep vein thrombosis or pulmonary embolism was 3%. Consider anti-coagulation prophylaxis after an assessment of each patient’s underlying risk factors.
Hematologic Toxicity
Neutropenia was the most frequently reported Grade 3/4 adverse event (AE), followed by anemia and thrombocytopenia. Neutropenia of any grade was reported in 50% of patients in the trial. The rate of Grade 3/4 neutropenia was 43%. The rate of febrile neutropenia was 3%.
Monitor patients for hematologic toxicities, especially neutropenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification [see Dosage and Administration (2.2)].
Hypersensitivity Reactions
Patients with a prior history of serious hypersensitivity associated with thalidomide or lenalidomide were excluded from studies and may be at higher risk of hypersensitivity.
Dizziness and Confusional State
In the trial, 18% of patients experienced dizziness and 12% of patients experienced a confusional state; 1% of patients experienced grade 3/4 dizziness, and 3% of patients experienced grade 3/4 confusional state. Instruct patients to avoid situations where dizziness or confusion may be a problem and not to take other medications that may cause dizziness or confusion without adequate medical advice.
Neuropathy
In the trial, 18% of patients experienced neuropathy, with approximately 9% of the patients experiencing peripheral neuropathy. There were no cases of grade 3 or higher neuropathy adverse reactions reported.
Risk of Second Primary Malignancies
Cases of acute myelogenous leukemia have been reported in patients receiving Pomalyst as an investigational therapy outside of multiple myeloma.
Adverse Reactions
The following adverse reactions are described in detail in other labeling sections:
•Fetal Risk [see Boxed Warnings, Warnings and Precautions (5.1, 5.2)]
•Venous Thromboembolism [see Boxed Warnings, Warnings and Precautions (5.3)]
•Hematologic Toxicity [see Warnings and Precautions (5.4)]
•Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
•Dizziness and Confusional State [see Warnings and Precautions (5.6)]
•Neuropathy [see Warnings and Precautions (5.7)]
•Risk of Second Primary Malignancies [see Warnings and Precautions (5.8)]
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 eva luated from 219 patients (safety population) who received treatment with Pomalyst + Low Dose Dexame |
