Important Safety Information ( continued )
CONTRAINDICATIONS
• Pregnancy : POMALYST can cause fetal harm and is contraindicated in females who are pregnant . If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug , the patient should be apprised of the potential risk to a fetus .
WARNINGS AND PRECAUTIONS
• Embryo-Fetal Toxicity & Females of Reproductive Potential : See Boxed WARNINGS
– Males : Pomalidomide is present in the semen of patients receiving the drug . 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 4 weeks after discontinuing POMALYST , even if they have undergone a successful vasectomy . Males must not donate sperm .
– Blood Donation : Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST .
• POMALYST REMS ® Program : See Boxed WARNINGS
– Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements ; pharmacies must only dispense to patients who are authorized to receive POMALYST . Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements ; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements .
– Further information about the POMALYST REMS program is available at www . CelgeneRiskManagement . com or by telephone at 1-888-423-5436 .
• Venous and Arterial Thromboembolism :
See Boxed WARNINGS . Patients with known risk factors , including prior thrombosis , may be at greater risk , and actions should be taken to try to minimize all modifiable factors ( e . g ., hyperlipidemia , hypertension , smoking ). Thromboprophylaxis is recommended , and the choice of regimen should be based on assessment of the patient ’ s underlying risk factors .
• Increased Mortality with Pembrolizumab : In clinical trials in patients with multiple myeloma , the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality . Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials .
• Hematologic Toxicity : Neutropenia ( 46 %) was the most frequently reported Grade 3 / 4 adverse reaction in patients taking POMALYST in clinical trials , followed by anemia and thrombocytopenia . Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter . Patients may require dose interruption and / or modification .
• Hepatotoxicity : Hepatic failure , including fatal cases , has occurred in patients treated with POMALYST . Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST . Monitor liver function tests monthly . Stop POMALYST upon elevation of liver enzymes . After return to baseline values , treatment at a lower dose may be considered .
• Severe Cutaneous Reactions Including Hypersensitivity Reactions : Angioedema and severe cutaneous reactions including Stevens- Johnson Syndrome ( SJS ), toxic epidermal necrolysis ( TEN ), and drug reaction with eosinophilia and systemic symptoms ( DRESS ) have been reported . DRESS may present with a cutaneous reaction ( such as rash or exfoliative dermatitis ), eosinophilia , fever , and / or lymphadenopathy with systemic complications such as hepatitis , nephritis , pneumonitis , myocarditis , and / or pericarditis . Discontinue POMALYST for angioedema , skin exfoliation , bullae , or any other severe cutaneous reactions such as SJS , TEN or DRESS , and do not resume therapy .
• Dizziness and Confusional State : In patients taking POMALYST in clinical trials , 14 % experienced dizziness ( 1 % Grade 3 or 4 ) and 7 % a confusional state ( 3 % Grade 3 or 4 ). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice .
• Neuropathy : In patients taking POMALYST in clinical trials , 18 % experienced neuropathy ( 2 % Grade 3 in one trial ) and 12 % peripheral neuropathy .
• Second Primary Malignancies : Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational