What’s the most critical endpoint? Over all, it’s survival.
The FDA recognizes overall survival (OS) as the most reliable and
preferred cancer endpoint. OS is an unbiased, objective endpoint
that is precise in its measurement. 1
Selected Safety Information: Boxed WARNINGS
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
POMALYST is only available through a restricted
Embryo-Fetal Toxicity
distribution program called POMALYST REMS ® .
• POMALYST is contraindicated in pregnancy.
POMALYST is a thalidomide analogue.
Venous and Arterial Thromboembolism
Thalidomide is a known human teratogen that
• Deep venous thrombosis (DVT), pulmonary
causes severe birth defects or embryo-fetal
embolism (PE), myocardial infarction, and stroke
death. In females of reproductive potential,
occur in patients with multiple myeloma treated
obtain 2 negative pregnancy tests before
with POMALYST. Prophylactic antithrombotic
starting POMALYST treatment.
measures were employed in clinical trials.
• Females of reproductive potential must use 2
Thromboprophylaxis is recommended, and the
forms of contraception or continuously abstain
choice of regimen should be based on assessment
from heterosexual sex during and for 4 weeks
of the patient’s underlying risk factors.
after stopping POMALYST treatment.
Please see brief summary of full Prescribing Information, including Boxed WARNINGS, and additional
Important Safety Information on the following pages.
POMALYST is only available through a restricted distribution program, POMALYST REMS ® .