Imbruvica Adverse Reactions





DCH Auriga - Healthcare
Four Star
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The safety profile is based on pooled data from 981 patients treated with IMBRUVICA in three phase 2 clinical studies and four randomised phase 3 studies and from post-marketing experience. Patients treated for MCL in clinical studies received IMBRUVICA at 560 mg once daily and patients treated for CLL or WM in clinical studies received IMBRUVICA at 420 mg once daily. All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated.
The most commonly occurring adverse reactions (≥ 20%) were diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia. The most common grade 3/4 adverse reactions (≥ 5%) were neutropenia, pneumonia, thrombocytopenia, and febrile neutropenia.
Tabulated list of adverse reactions: Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed as follows by system organ class and frequency grouping. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 9.)

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Discontinuation and dose reduction due to adverse drug reactions: Of the 981 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions. These included pneumonia, atrial fibrillation and haemorrhage. Adverse reactions leading to dose reduction occurred in approximately 5% of patients.
Elderly: Of the 981 patients treated with IMBRUVICA, 62% were 65 years of age or older. Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (13% of patients age ≥ 65 versus 7% of patients < 65 years of age).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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