其 他 安 全 警 示
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| The United Kingdom: The potential risk of second primary malignancies in patients treated with Revlimid (lenalidomide) - information for healthcare professionals(English Only) |
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Celgene Europe Limited, in agreement with the European Medicines Agency and MHRA, wishes to inform you about important new information on the clinical safety of Revlimid (lenalidomide). A higher incidence of second primary malignancies in patients treated with lenalidomide compared to controls has been observed in clinical studies conducted outside of the authorised indication. Revlimid is authorised in the European Union (EU) for use in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Use of lenalidomide for indications other than the authorised indication falls outside the scope of the current benefit-risk review. The use of lenalidomide in unlicensed indications is not recommended. Healthcare professionals should carefully consider the balance of risk and benefit of any off-label use.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/Monthlylistsofinformationforhealthcareprofessionalsonthesafetyofmedicines/CON117263
Situation in Hong Kong: Revlimid Cap 5mg, 10mg, 15mg and 25mg are registered by Celgene Ltd and are prescription medicines. Similar news was posted on the website of Pharmaceutical Service on 9 April 2011 and a letter to inform healthcare professionals was issued on the same day.
Ends/ Thursday, May 5, 2011
Issued at HKT 15:30
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