AbbVie: Rinvoq website dosing statement ‘with or without food’ (AUTH/3705/11/22) – no breach | PMCPA Case

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Key facts

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Case number	AUTH/3705/11/22
Company	AbbVie
Complainant	Anonymous, contactable complainant
Product	Rinvoq (upadacitinib) 15mg tablets
Channel/material	AbbViePro (UK HCP product website) dosing webpage
Main allegation	Dosing statement “with or without food” omitted grapefruit avoidance advice in SPC and allegedly implied Rinvoq could be taken with any food including grapefruit
Applicable Code	2021
Clauses considered	2, 5.1, 6.1, 6.2
Decision	No breach of Clauses 2, 5.1, 6.1, 6.2
Complaint received	14 November 2022
Case completed	20 November 2023
Appeal	No appeal

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

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An anonymous, contactable complainant challenged dosing information for Rinvoq (upadacitinib) on AbbVie’s UK HCP product website (AbbViePro).
The webpage’s ‘Dosing recommendations’ section stated: “The recommended dose of RINVOQ is one 15-mg tablet once a day, with or without food”.
The complainant argued this was inconsistent with the SPC because the SPC advises avoiding food or drink containing grapefruit, and the webpage did not mention grapefruit in that dosing claim.
The complainant alleged the wording implied Rinvoq could be taken with any food (including grapefruit), potentially increasing exposure and side effects, and noted Rinvoq is a black triangle medicine.
AbbVie responded that grapefruit avoidance was signposted elsewhere on the webpage via links to the Rinvoq Prescribing Guide and Prescribing Information, and that the challenged sentence directly reflected SPC Section 4.2 ‘Method of administration’ wording.
The Panel noted that claims must be able to stand alone for Code compliance and cannot rely on linked materials to qualify them, but assessed the meaning of the claim within the discrete section where it appeared.

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No breach of Clause 6.1.
No breach of Clause 6.2.
No breach of Clause 5.1.
No breach of Clause 2.
The Panel concluded that, in the narrow context of the ‘Dosing recommendations’ section, HCPs would interpret “with or without food” as referring to taking the tablet on an empty stomach vs with meals—not as an unqualified statement that it could be taken with any food including grapefruit.
The Panel considered the claim was capable of substantiation because it reflected SPC Section 4.2 wording.

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Clause 2 – Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry – No breach.
Clause 5.1 – Requirement to maintain high standards – No breach.
Clause 6.1 – Requirement that information, claims and comparisons must not be misleading – No breach.
Clause 6.2 – Requirement that information, claims and comparisons must be capable of substantiation – No breach.

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