Dear Healthcare Professional Letter on potentiation of radiation toxicity associated with Zelboraf (vemurafenib)
20.10.2015
Roche d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) would like to inform healthcare professionals of the potentiation of radiation toxicity associated with Zelboraf (vemurafenib).
Summary
- Severe cases of radiation-related injuries , some with fatal outcome, have been reported in patients treated with radiation either before, during, or following treatment with Zelboraf.
- Most cases were cutaneous in nature but some cases involved visceral organs.
- Zelboraf should be used with caution when given before, during, or following radiation treatment.
Further information
A safety analysis of radiation-related adverse events reported with vemurafenib use concluded that potentiation ofradiation treatment toxicity constitutes an adverse drug reaction for vemurafenib. This conclusion is based on 20 cases of radiation injuries adjudicated as radiation recall (n=8 cases) and radiation sensitisation (n=12 cases). The nature and severity of the events in all 20 cases were evaluated as worse than expected for the normal tissue tolerance to therapeutic radiation. The product information (Summary of Product Characteristics and Package Leaflet) will be updated with information of this risk of potentiation of radiation toxicity.
Zelboraf is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
