Ibrutinib

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A man in his 80s developed grade 3 neutropenia and fever during treatment with ibrutinib for relapsed mantle cell lymphoma.

The man was diagnosed with mantle cell lymphoma in November 2014 and received treatment with R-CHOP chemotherapy comprising of rituximab, cyclophosphamide, vincristine, doxorubicin and prednisone. Then, BORID chemotherapy comprising of bortezomib, rituximab and dexamethasone; and R-BAC chemotherapy comprising of rituximab, bendamustine and cytarabine. He had a relapse of mantle cell lymphoma in September 2017. Therefore, started receiving treatment with ibrutinib 560mg daily [route not stated] and achieved complete remission. In May 2020, he presented with diarrhoea and dyspnea. His vital signs were as follows: body temperature was 38°C, pulse rate was 112 bpm, respiratory rate was 22 bpm and oxygen saturation was 91%. Subsequently, his real-time reverse transcriptase-polymerase chain reaction was positive for SARS-COVID-19. Also, his chest CT scan showed pneumonia. Therefore, he started receiving off label treatment with hydroxychloroquine along with levofloxacin and prophylactic low-molecular-weight heparin. However, he developed grade 3 neutropenia and fever.

Therefore, the man's treatment with ibrutinib was stopped. Following 6 days, he developed swelling on the left orbital and mass lesions on the left hard palate. Thereafter, his complete blood count revealed haematological recovery.

Then, the man started receiving treatment with dexamethasone for 4 days along with ibrutinib re-started. Later, his mass over the hard palate regressed and symptoms of COVID-19 resolved. He had been receiving treatment with ibrutinib and mantle cell lymphoma was in remission.