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 Use in Specific Populations (8.1)].

Hematologic Toxicity

Inform patients that REVLIMID is associated with significant neutropenia and thrombocytopenia [see Boxed Warnings and Warnings and Precautions (5.3)].

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 eva luation [see Boxed Warnings and Warning and Precautions (5.4)].

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 Precautions (5.5)].

Second Primary Malignancies

Inform patients of the potential risk of developing second primary malignancies during treatment with REVLIMID [see Warnings and Precautions (5.6)].

Hepatotoxicity

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 eva luation [see Warnings and Precautions (5.7)].

Allergic Reactions

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 eva luation [see Warnings and 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 eva luation [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 eva luation [see Warnings and Precautions (5.10)].

Dosing Instructions

Inform patients how to take REVLIMID [see Dosage and Administration (2)]
REVLIMID should be taken once daily at about the same time each day,
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.
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