Prescribers of ponatinib are being warned of a risk of posterior reversible encephalopathy syndrome (PRES) that could affect up to 1 in 100 patients taking this treatment. Treatment should be interrupted if PRES is confirmed, and resumed only when it has resolved and if the benefits of continuing treatment outweigh the risk of PRES.
PRES is a neurologic disorder that can present with seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurologic disturbances.
The advice comes from the UK Medicines and Healthcare products Regulatory Agency following a routine EU post-marketing review of ponatinib that identified five cases of PRES; two cases improved after treatment withdrawal, and did not reappear when restarted at a lower dose. PRES is now listed as an uncommon adverse event (could affect up to 1 in 100 people) in the Summary of Product Characteristics and Patient Leaflet for ponatinib. The US prescribing information for ponatinib already warns about the risk of PRES.
Ponatinib (a tyrosine kinase inhibitor) is indicated for adults with Philadelphia chromosome positive acute lymphoblastic leukemia who are resistant or unsuitable for treatment with other tyrosine kinase inhibitors, or who have the T315I mutation.
Patients receiving ponatinib should be advised to contact their healthcare professional immediately if they develop sudden-onset severe headache, confusion, seizures, or vision changes.
See Management: approach See Management: treatment algorithmConsultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
MO declares that she has no competing interests.
Senior Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
None declared.
Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
EC declares that she has no competing interests.
Consultant
Department of Haematology-Oncology
National University Cancer Institute
Singapore
CHN declares that he has no competing interests.
Dr Melissa Ooi, Dr Michelle Poon, Dr Esther Chan, and Dr Chin Hin Ng would like to gratefully acknowledge Dr Arati V. Rao, Dr Matthew Smith, Dr Samer Bleibel, and Dr Robert Leonard, previous contributors to this monograph. AVR, MS, SB, and RL declare that they have no competing interests.
Staff Physician
Department of Hematology and Oncology
New England Medical Center
Tufts University
Boston
MA
OK declares that she has no competing interests.
Consultant Haematologist
Department of Haematology and Stem Cell Transplantation
Heartlands Hospital
Birmingham
UK
SP declares that he has no competing interests.
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