POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including
lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM
Embryo-Fetal Toxicity
• POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen
that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy
tests before starting POMALYST treatment
• Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during
and for 4 weeks after stopping POMALYST treatment
POMALYST is only available through a restricted distribution program called POMALYST REMS™.
Venous Thromboembolism
• Deep venous thrombosis (DVT) and pulmonary embolism (PE) occur in patients with multiple myeloma treated with
POMALYST. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures
after assessing an individual patient’s underlying risk factors
CONTRAINDICATIONS: Pregnancy
• POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If this drug is used during pregnancy or
if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus
• Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period
of organogenesis
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
• Females of Reproductive Potential: Must avoid pregnancy while taking POMALYST and for at least 4 weeks after completing
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therapy. Must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 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. Must obtain 2 negative pregnancy tests prior to initiating therapy
• 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 28 days 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 1 month 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
Because of the embryo-fetal risk, POMALYST is available only through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS) called “POMALYST REMS.” Prescribers and pharmacies must be certified with the program; patients
must sign an agreement form and comply with the requirements. Further information about the POMALYST REMS program is
available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
Venous Thromboembolism: Patients receiving POMALYST have developed venous thromboembolic events reported as serious
adverse reactions. In the trial, all patients were required to receive prophylaxis or antithrombotic treatment. The rate of DVT or
PE was 3%. Consider anticoagulation prophylaxis after an assessment of each patient’s underlying risk factors.
Hematologic Toxicity: Neutropenia of any grade was reported in 50% of patients and was the most frequently reported Grade
3/4 adverse reaction, followed by anemia and thrombocytopenia. Monitor patients for hematologic toxicities, especially
neutropenia, with complete blood counts weekly for the first 8 weeks and monthly thereafter. Treatment is continued or modified
for Grade 3 or 4 hematologic toxicities based upon clinical and laboratory findings. Dosing interruptions and/or modifications
are recommended to manage neutropenia and thrombocytopenia.
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: 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 confusional state may be a problem and not to take other medications that may cause
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