Direct healthcare professional communication on the risk of infections related to the the use of Zydelig (idelalisib)
02.03.2017
Medicopharmacia d.o.o., the local representative of Gilead Sciences International Ltd, the marketing authorisation holder for Zydelig (idelalisib), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the risk of infections related to the the use this medicine.
Summary
- Based on the conclusions from the safety review, the indication for Zydelig in first line treatment of adult patients with chronic lymphocytic leukaemia (CLL) patients has been updated to the use in combination with anti-CD20 monoclonal antibody (rituximab or ofatumumab) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
- In addition, Zydelig is also indicated in combination with anti-CD20 monoclonal antibody (rituximab or ofatumumab) for treatment of adult patients with CLL who have received at least one prior therapy and as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
- In order to reduce the risk of infection in all indications, risk minimization measures have been updated with new guidelines regarding Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV) infection:
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- All patients treated with Zydelig should receive prophylaxis for PJP during treatment as well as for up to 2 to 6 months after discontinuation of treatment. The duration of post-treatment prophylaxis should be based on clinical judgment, taking into account the patient's risk factors, such as concomitant corticosteroid treatment and prolonged neutropenia.
- Regular clinical and laboratory monitoring for possible CMV infection is recommended in patients who are CMV-seropositive at the beginning of treatment with idelalisib or have other evidence of a history of CMV infection. Patients with CMV viraemia but without clinical signs of CMV infection should be carefully monitored. For patients with evidence of CMV viraemia and clinical signs of CMV infection, consideration should be given to interrupting idelalisib until the infection has resolved. If the benefits of resuming idelalisib are judged to outweigh the risks, pre-emptive CMV therapy should be considered.
Further information
In 2016, a safety review for this medicine was conducted on the level of the European Union (EU). It encompassed interim results from three clinical trials, which showed increased numbers of fatal cases related to infections in the idelalisib treatment arm, because of which they have been stopped. These clinical trials involved patient populations and treatment combinations that are not authorised in the EU.
This communication provides healthcare professionals with information on the conclusions of the review as well as on the current recommendations specified in the Summary of Product Characteristics (SmPC).
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded 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. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
