Calquence Adverse Reactions

Overall Summary of Adverse Drug Reactions: The overall safety profile of acalabrutinib is based on pooled data from 1040 patients with haematologic malignancies receiving acalabrutinib monotherapy.
The most common (≥20%) adverse drug reactions (ADRs) of any grade reported in patients receiving acalabrutinib were infection, headache, diarrhoea, bruising, musculoskeletal pain, nausea, fatigue, and rash.
The most commonly reported (≥5%) Grade ≥3 adverse reactions were infection (17.6%), neutropenia (14.2%), and anaemia (7.8%).
Dose reductions due to adverse events were reported in 4.2% of patients. Discontinuation due to adverse events were reported in 9.3% of the patients. The median dose intensity was 98.7%.
Tabulated list of adverse reactions: The following adverse drug reactions (ADRs) have been identified in clinical studies with patients receiving CALQUENCE monotherapy as treatment for haematological malignancies. The median duration of acalabrutinib monotherapy treatment across the pooled dataset was 24.6 months.
Adverse drug reactions are listed according to system organ class (SOC) in MedDRA. Within each system organ class, the adverse drug reactions are sorted by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each ADR is based on the CIOMS III convention and is defined as: very common (≥1/10); common (>1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from available data). (See Tables 11 and 12.)

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Special populations: Elderly: Of the 1040 patients in clinical trials of CALQUENCE monotherapy, 41% were greater than 65 years of age and less than 75 years of age and 22% were 75 years of age or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 years and younger.