Information about Valdoxan for health care professionals

10/10/2012

SURESNES, France, October 10, 2012

Important safety information for health care professionals

Servier informs all potential prescribers about the update of the proper use of Valdoxan decided in concert with the European Medicines Agency, and mainly designed to optimize the safety of patients treated with Valdoxan.

As stated in the updated Summary of Product Characteristics, liver function tests should be performed in all patients: at initiation of treatment, and then periodically after around three weeks, six weeks (end of acute phase), twelve weeks, and twenty-four weeks (end of maintenance phase), and thereafter when clinically indicated. When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.

If symptoms or signs of potential liver injury (dark urine, light-colored stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue) areobserved, Valdoxan therapy should be discontinued.

Click here to download the “Direct Health care Professional Communication” letter.
Click here to download the updated Summary of Product Characteristics.

Click here to download the "liver function monitoring scheme with Valdoxan":
This leaflet has been developed to give to healthcare providers an easy-to-read, easy-to-understand liver function monitoring scheme for Valdoxan. We advise each physician to comply fully with the stipulated liver function guidelines.