( ut REVLIMID(R) (lenalidomide) and theR...)ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03),Reports Lenalidomide Plus Low-Dose Dexamethasone Suggests Survival,Advantage for Patients with Multiple Myeloma,Health

ADDITIONAL WARNINGS: HEMATOLOGIC TOXICITY

Multiple Myeloma

In the pooled multiple myeloma studies Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of REVLIMID(R) (lenalidomide) and dexamethasone than in patients treated with dexamethasone alone. Patients on therapy should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter. Patients may require dose interruption and/or dose reduction.

CONTRAINDICATIONS:

Hypersensitivity: REVLIMID(R) (lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.

PRECAUTIONS:

Renal impairment: REVLIMID(R) (lenalidomide) is substantially excreted by the kidney, so the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function.

Nursing mothers: It is not known whether REVLIMID(R) (lenalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS:

Multiple Myeloma:

In the REVLIMID(R) (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID(R) (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID(R) (le
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