Dear Healthcare Professional Letter on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib)
13.10.2015
Pfizer Croatia 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 on the new warning with regard to the risk of heart failure associated with the use of Xalkori (crizotinib).
Summary
- Severe cases, sometimes with a fatal outcome of heart failure in patients with non-small cells lung cancer , positive for kinase of anaplastic lymphoma, treated with crizotinib, have been reported
- Thre heart failure developed in patients with existing heart diseases or without them, receiving crizotinib.
- Patients should be monitored in the case of signs and symptoms of heart failure (dyspnoea, oedema, increase in body mass).
- In the case of these symptoms, adequate measures should be considered, such as a change in posology, dose decrease or stopping of treatment.
More information
The active substance in Xalkori is crizotinib. Xalkori is indicated for treatment of adult patients previously treated for advanced non-small cell lung cancer whose tumours are anaplastic lymphoma kinase positive.
According to a safety review of crizotinib, based on clinical trials data and reports from clinical practice, it is concluded that there is a risk of heart failure after crizotinib treatment. Warnings on this risk and information on adverse reactions are included in the Summary of Product Characteristics with the aim to minimise the risk of heart failure.
The Dear Healthcare Professional Letter is accessible here.
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.
