Important safety information for RINVOQ^®(upadacitinib) in Rheumatological conditions.¹

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

RINVOQ should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of Rheumatological conditions.

Some patients may not be suitable for RINVOQ^® (upadacitinib). You are strongly advised to read the prescribing information, which can be found HERE and at the top of this webpage, safety information which can be found HERE and below, Summary of Product Characteristics (SmPC) and Risk Materials which are available online in the Electronic Medicines Compendium (EMC) from the links below.

RINVOQ Great Britain EMC SmPC & Risk Materials:

SmPC CLICK HERE & Risk Materials CLICK HERE

RINVOQ Northern Ireland EMC SmPC & Risk Materials:

SmPC CLICK HERE & Risk Materials CLICK HERE

RINVOQ is contraindicated in patients;

• with hypersensitivity to the active substance or to any of the excipients,
• with active tuberculosis (TB) or active serious infections,
• with severe hepatic impairment,
• who are pregnant.

Cautions (See Prescribing Information and SmPC for full details including screening and monitoring requirements):

RINVOQ should only be used if no suitable treatment alternatives are available in patients;

• 65 years of age or older,
• with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers),
• with malignancy risk factors (e.g., current malignancy or history of malignancy).

RINVOQ is contraindicated in pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of RINVOQ. RINVOQ should not be used during breast feeding. A decision must be made whether to discontinue breast-feeding or to discontinue RINVOQ therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Concomitant potent immunosuppressive medicines are not recommended. Contraindicated in active serious infections (including tuberculosis). Increased risk of serious infection and viral reactivation (including herpes simplex and zoster reactivation) during treatment. Live attenuated vaccinations during or immediately prior to upadacitinib not recommended.

Cautions apply in patients ≥65 years, patients with malignancy risk factors; lymphoma and malignancies (including non-melanoma skin cancer) have been reported.

Haematological abnormalities: do not start, or temporarily interrupt existing therapy if: ANC < 1 x 10⁹ cells/L, ALC < 0.5 x 10⁹ cells/L or haemoglobin < 8 g/dL. Haematological abnormalities have been reported. Caution in patients with risk factors for: gastrointestinal perforation (e.g. diverticular disease, NSAIDs, corticosteroids, opioids); cardiovascular disease/major adverse cardiac events; venous thromboembolism; severe renal and hepatic impairment (not recommended in end-stage renal impairment and to be used with caution in severe renal impairment, contraindicated in severe hepatic impairment). Hepatic transaminase elevations, increase in lipids including total cholesterol during treatment and hypersensitivity reactions have been reported. Reports of hypoglycaemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycaemia occurs. Upadacitinib dose adjustment may be required with CYP3A4 inhibitors/inducers (see SmPC), avoid food/drink containing grapefruit.

Dosing in Rheumatological Conditions

Rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS)

The recommended dose of RINVOQ is 15 mg once daily.

Consideration should be given to discontinuing treatment in patients with axial spondyloarthritis who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Adverse reactions

For adverse reactions, please refer to the prescribing information and the RINVOQ Summary of Product Characteristics available online in the Electronic Medicines Compendium via the links above.