RINVOQ 45 mg prolonged-release tablets

Section 4.4

The following text has been added:

Hypoglycaemia in patients treated for diabetes

There have been reports of hypoglycaemia following initiation of JAK inhibitors, including upadacitinib, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycaemia occurs.

Section 4.1

• The following indication has been added:

Crohn’s disease

 RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Section 4.2

• Dosing information updated to reflect Crohn's disease indication.

Section 4.4

• Information added regarding gastrointestinal perforation

Section 4.5

• The paragraph relating to "Coadministration with CYP3A4 inhibitors" has been updated to include patients with Crohn's disease.

Section 4.8

• Updated to include the most commonly reported adverse reactions in placebo-controlled Crohn's disease induction and maintenance clinical trials.
• Table 3 - Adverse reactions table has been updated as follows:
• Frequency of pneumonia changed from Uncommon to Common
• Gastrointestinal perforation added as an uncommon adverse reaction
• Section added regarding safety information in patients with Crohn's disease (serious infections, gastrointestinal perforation, laboratory abnormalities)

Section 5.1

• Mechanism of action paragraph: ulcerative colitis amended to inflammatory bowel disease.
• Section added regarding clinical efficacy and safety for Crohn's disease indication

Section 5.2

• Minor editorial changes to "Renal impairment" section
• Crohn's disease added to Paediatric population section

Section 5.3

• Updates made to clinical exposure dosing information

Section 10.0

• Date of revision of text updated to 04/2023

Section 4.2

Atopic dermatitis and Ulcerative colitis sections updated.

Section 4.4

The following warning has been added

Upadacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;

patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);

patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Section added regarding use in patients 65 years of age and older

Serious infections section updated.

Malignancy and non-melanoma skin cancer section updated.

Section on Major Adverse cardiovascular events (MACE) added

Venous thromboembolism section updated.

Section 4.8

Non-melanoma skin cancer added as a common Adverse reaction.

Sepsis added an Uncommon adverse reaction.

Section 4.4

The following has been added:

Hypersensitivity reactions

Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving upadacitinib. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy (see sections 4.3 and 4.8).

Section 4.8

Table 3 Adverse Reactions

Urticaria moved to Immune System Disorders (System Organ Class)

Serious hypersensitivity reactions added as an uncommon side effect

Section 10

Date of revision of text updated to 11/2022