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WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM
See full prescribing information for complete boxed warning
EMBRYO-FETAL TOXICITY
• POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known
human teratogen that causes severe life-threatening birth defects
• For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy
during treatment by the use of 2 reliable methods of contraception
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
CONTRAINDICATIONS
Pregnancy
POMALYST can cause fetal harm when administered to a pregnant female. POMALYST is contraindicated in females who are
pregnant. Pomalidomide is a thalidomide analogue, and is teratogenic in both rats and rabbits when administered during
the period of organogenesis. 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.
POMALYST is only available through a restricted
distribution program, POMALYST REMS™.
Please see brief summary of full Prescribing Information,
including Boxed WARNINGS, CONTRAINDICATIONS,
WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS,
and Important Safety Information on following pages.