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Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency
Date:1/24/2008

comprehensive safety program in place.

The Company holds exclusive marketing and distribution rights from Celgene Corporation for Thalidomide in markets outside of North America, Japan and certain other Asian countries.

Safety Information

Thalidomide Pharmion warning:

Teratogenic effects.

Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life threatening birth defects. Thalidomide must never be used by women who are pregnant or could become pregnant. The conditions of the Thalidomide Pharmion Pregnancy Prevention Programme must be fulfilled for all male and female patients

The common adverse reactions associated with the use of Thalidomide in combination with other anti-myeloma therapies are: deep vein thrombosis, constipation, peripheral oedema, tremor, dizziness, fatigue, asthenia, somnolence, peripheral neuropathy, neutropenia, lymphopenia, leucopenia, anaemia, thrombocytopenia, paraesthesia and dysaesthesia. Serious or severe reactions associated with Thalidomide use are: deep vein thrombosis and pulmonary embolism, bradycardia, cerebrovascular accident, peritonitis, orthostatic hypotension, and severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis. Thromboprophylaxis should be used when Thalidomide is prescribed in combination with other anti-myeloma therapies. Peripheral neuropathy is a potentially severe, adverse effect of treatment with Thalidomide that may result in irreversible damage. Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks. Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all. Thalidomide frequently causes drowsiness, somnolence and sedation. Patients should be instructed to avoid situations where drowsiness may be a pr
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SOURCE Pharmion Corporation
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