AstraZeneca breached Clauses 6.1 and 5.1 after Calquence dosing leaflet omitted monitoring caveat for moderate hepatic impairment (AUTH/3846/11/23)

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Key facts

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Case	AUTH/3846/11/23
Company	AstraZeneca UK Limited
Complainant	Anonymous, contactable health professional
Medicine	Calquence (acalabrutinib) (black triangle)
Material	8-page digital leaflet/leave piece: “HOW TO DOSE CALQUENCE (acalabrutinib) TABLETS” (GB-48523; date of preparation September 2023)
Main issue	Omitted SmPC caveat that patients with moderate hepatic impairment should be closely monitored for signs of toxicity, while stating no dose adjustment required
Applicable Code	2021
Breach clauses	Clause 6.1; Clause 5.1
No breach clauses	Clause 2; Clause 3.3
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	03 November 2023
Case completed	28 November 2024
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable health professional complained about an 8-page Calquence (acalabrutinib) tablet dosing resource (GB-48523; date of preparation September 2023).
Page 4 stated: “No dose adjustment of CALQUENCE is required in patients with mild or moderate renal impairment, mild or moderate hepatic impairment, or for elderly patients (aged ≥ 65 years)”.
The SmPC (section 4.2) included an important caveat: patients with moderate hepatic impairment should be closely monitored for signs of toxicity.
The complainant argued the omission was particularly important because Calquence is a black triangle product and the SmPC flagged toxicity monitoring.
AstraZeneca said the monitoring requirement appeared in the prescribing information within the leaflet (page 6) but accepted that, for completeness, it should have been included in the dosing section; it described the omission as human error.
AstraZeneca removed the digital resource within 24 hours, recalled hard copies, and updated both versions to include the monitoring requirement.
The complainant also alleged AstraZeneca breached a previous undertaking (referencing AUTH/3618/3/22, Forxiga) by again missing important safety information.

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Breach of Clause 6.1 (information must be accurate, up-to-date and not misleading).
Breach of Clause 5.1 (maintain high standards at all times).
No breach of Clause 2 (discredit/reduce confidence in the industry).
No breach of Clause 3.3 (comply with an undertaking).
No appeal.

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