REVLIMID REMS program
Because of the risk of embryo-fetal toxicity, REVLIMID is only available
through a restricted program called the REVLIMID REMS program [see
Warnings and Precautions (5.2)].
• Patients must sign a Patient-Physician agreement form and comply
with the requirements to receive REVLIMID. In particular, females of
reproductive potential must comply with the pregnancy testing,
contraception requirements and participate in monthly telephone
surveys. Males must comply with the contraception requirements
[see Use in Specific Populations (8.3)].
• REVLIMID is available only from pharmacies that are certified in
REVLIMID REMS program. Provide patients with the telephone
number and website for information on how to obtain the product.
Pregnancy Exposure Registry
Inform females there is a Pregnancy Exposure Registry that monitors
pregnancy outcomes in females exposed to REVLIMID during pregnancy
and that they can contact the Pregnancy Exposure Registry by calling
1-888-423-5436 [see Usein Specific Populations (8.1)].
Inform patients that REVLIMID is associated with significant neutropenia
and thrombocytopenia [see Boxed Warningsand Warnings and
Venous and Arterial Thromboembolism
Inform patients of the risk of thrombosis including DVT, PE, MI, and
stroke and to report immediately any signs and symptoms suggestive of
these events for evaluation [see Boxed Warnings and Warning and
Increased Mortality in Patients with CLL
Inform patients that REVLIMID had increased mortality in patients with
CLL and serious adverse cardiovascular reactions, including atrial
fibrillation, myocardial infarction, and cardiac failure [see Warning and
Second Primary Malignancies
Inform patients of the potential risk of developing second primary
malignancies during treatment with REVLIMID [see Warningsand
Inform patients of the risk of hepatotoxicity, including hepatic failure and
death, and to report any signs and symptoms associated with this event
to their healthcare provider for evaluation [see Warningsand Precautions
Inform patients of the potential for allergic reactions including
hypersensitivity, angioedema, Stevens-Johnson Syndrome, or toxic
epidermal necrolysis if they had such a reaction to THALOMID and report
symptoms associated with these events to their healthcare provider for
evaluation [see Warningsand Precautions (5.8)].
Tumor Lysis Syndrome
Inform patients of the potential risk of tumor lysis syndrome and to
report any signs and symptoms associated with this event to their
healthcare provider for evaluation [see Warnings and Precautions (5.9)].
Tumor Flare Reaction
Inform patients of the potential risk of tumor flare reaction and to report
any signs and symptoms associated with this event to their healthcare
provider for evaluation [see Warningsand Precautions(5.10)].
Inform patients how to take REVLIMID [see Dosage and Administration
• REVLIMID should be taken once daily at about the same time each
• REVLIMID may be taken either with or without food.
• The capsules should not be opened, broken, or chewed. REVLIMID
should be swallowed whole with water.
• Instruct patients that if they miss a dose of REVLIMID, they may still
take it up to 12 hours after the time they would normally take it. If
more than 12 hours have elapsed, they should be instructed to skip
the dose for that day. The next day, they should take REVLIMID at
the usual time. Warn patients to not take 2 doses to make up for the
one that they missed.
Manufactured for: Celgene Corporation
REVLIMID®, REVLIMID REMS® and THALOMID® are registered trademarks
of Celgene Corporation.
©2005-2017 Celgene Corporation, All Rights Reserved.