Fluorouracil,capecitabine, tegafur and flucytosine: recommendation for testing and treatment
2020.08.04
Active substance: fluorouracil | capecitabine | tegafur | flucytosine
04.08.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission with a notice in the national graduated plan procedure.
05.05.2020 - CHMP opinion
EMA recommendations for testing the enzyme activity of DPD before starting treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has confirmed the recommendation of the PRAC that patients should be tested for the absence or partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) before starting cancer treatment with drugs containing fluorouracil, administered by injection or infusion (drip), or with the related active substances capecitabine and tegafur.
16.03.2020 - PRAC recommendation
The Committee for Pharmacovigilance Risk Assessment (PRAC) of the European Medicines Agency (EMA) recommends that patients should be tested for the absence or partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) before starting cancer treatment with fluorouracil-containing drugs administered by injection or infusion (drip). This recommendation applies accordingly to treatment with the related active ingredients capecitabine and tegafur, which are converted into fluorouracil in the body.
19.03.2019 - Procedure started
EMA has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects.
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency: