Calquence Adverse Reactions

Overall Summary of Adverse Drug Reactions: CALQUENCE Monotherapy: The overall safety profile of acalabrutinib monotherapy is based on pooled data from 1,478 patients with haematologic malignancies receiving acalabrutinib monotherapy. The median duration of acalabrutinib monotherapy treatment across the pooled dataset was 38.2 months.
The most common (≥20%) adverse drug reactions (ADRs) of any grade reported in patients receiving acalabrutinib monotherapy were infection, diarrhoea, headache, musculoskeletal pain, bruising, arthralgia, fatigue, nausea, leukopenia and rash.
The most commonly reported (≥5%) Grade ≥3 adverse drug reactions were infection , leukopenia, neutropenia, anaemia, second primary malignancies, thrombocytopenia and second primary malignancies excluding non-melanoma skin.
Dose reductions due to adverse events were reported in 5.9% of patients. Discontinuation due to adverse events were reported in 14.6% of the patients. The median dose intensity was 98.2%.
The adverse drug reactions for patients receiving acalabrutinib monotherapy are listed in Table 16.
CALQUENCE in combination with obinutuzumab: The overall safety profile of acalabrutinib in combination with obinutuzumab is consistent with the known safety profile of acalabrutinib monotherapy and that of obinutuzumab.
CALQUENCE in combination with bendamustine and rituximab: The overall safety profile of acalabrutinib in combination with bendamustine and rituximab is based on pooled data from 297 patients receiving acalabrutinib in combination with bendamustine and rituximab. The median duration of CALQUENCE exposure in patients treated with CALQUENCE in combination with bendamustine and rituximab was 28.6 months.
The most common (≥20%) adverse drug reactions (ADRs) of any grade reported in patients receiving acalabrutinib in combination with bendamustine and rituximab were infection, leukopenia, neutropenia, nausea, rash, diarrhoea, musculoskeletal pain, headache, fatigue, vomiting, constipation, anaemia and thrombocytopenia.
The most commonly reported (≥5%) Grade ≥3 adverse drug reactions were leukopenia, neutropenia, infection, rash, thrombocytopenia, anaemia, second primary malignancies and second primary malignancies excluding non-melanoma skin.
Dose reductions due to adverse events were reported in 10.1% of patients. Discontinuation due to adverse events were reported in 42.8% of the patients. The median dose intensity was 96.3%.
The adverse drug reactions for patients receiving acalabrutinib in combination with bendamustine or rituximab are listed in Table 18.
CALQUENCE in combination with venetoclax with or without obinutuzumab: The overall safety profile of acalabrutinib in combination with venetoclax with or without obinutuzumab is based on pooled data from 291 patients receiving acalabrutinib in combination with venetoclax and 284 patients receiving acalabrutinib in combination with venetoclax and obinutuzumab. The median duration of CALQUENCE exposure in patients treated with CALQUENCE in combination with venetoclax with or without obinutuzumab was 12.9 months.
The most common (≥20%) adverse drug reactions (ADRs) of any grade reported in patients receiving acalabrutinib in combination with venetoclax were infection, leukopenia, neutropenia, headache, diarrhoea, musculoskeletal pain and bruising.
The most commonly reported (≥5%) Grade ≥3 adverse drug reactions in patients receiving acalabrutinib in combination with venetoclax were neutropenia and infection.
Acalabrutinib dose reductions in patients due to adverse events were reported in 5.8% of patients receiving acalabrutinib in combination with venetoclax. Discontinuation due to adverse events were reported in 7.6% of the patients. The median dose intensity was 99.5%.
The most common (≥20%) adverse drug reactions (ADRs) of any grade reported in patients receiving acalabrutinib in combination with venetoclax and obinutuzumab were infection, leukopenia, neutropenia, diarrhoea, headache, nausea, musculoskeletal pain and bruising.
The most commonly reported (≥5%) Grade ≥3 adverse drug reactions in patients receiving acalabrutinib in combination with venetoclax and obinutuzumab were leukopenia, neutropenia, infection and thrombocytopenia.
Acalabrutinib dose reductions due to adverse events were reported in 6.3% of patients receiving acalabrutinib in combination with venetoclax and obinutuzumab. Discontinuation due to adverse events were reported in 13.7% of the patients. The median dose intensity was 98.1%.
The adverse drug reactions for patients receiving acalabrutinib in combination with venetoclax with or without obinutuzumab are listed in Table 20.
Tabulated list of adverse reactions: The following tables present adverse drug reactions (ADRs) identified in clinical studies with patients receiving CALQUENCE monotherapy or combination therapy for haematological malignancies.
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 <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data). (See Tables 16, 17, 18, 19, 20 and 21.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Special populations: Elderly: Of the 1,478 patients in clinical trials of CALQUENCE monotherapy, 42% were 65 years of age or older and less than 75 years of age and 20.6% were 75 years of age or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 years and younger.