Bortezomib/dexamethasone off label use
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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective observational study performed between November 2014 to December 2017, 6 patients [4 woman and 2 men] aged 34−70 years were described, who developed thrombocytopenia, abdominal pain, vomiting, peripheral neuropathy, blepharitis or sepsis following an off label treatment with bortezomib and dexamethasone [not all routes stated] for warm autoimmune haemolytic anaemia (wAIHA) [duration of treatments to reactions onsets not stated; not all outcomes stated].
Patient 1: A 55-year-old woman had a history of systemic lupus erythematosus (SLE) and wAIHA. She was multi-refractory to treatment of wAIHA. Subsequently, she started receiving an off label treatment with 6 cycles of bortezomib 13 mg/m 2on days 1, 4, 8 and 11 (21-day cycle) in combination with oral...