RINVOQ

What it is

RINVOQ contains upadacitinib hemihydrate, equivalent to 15 mg, 30 mg, or 45 mg of upadacitinib, a Janus Kinase (JAK) inhibitor. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— 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). — Moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs. — Active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) change, who have responded inadequately to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). — Active ankylosing spondylitis in adults. — Moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who weigh at least 40 kg, which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated. — Moderately to severely active ulcerative colitis in adult patients who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine. — Moderately to severely active Crohn's disease in adult patients who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.

Dosing overview

For rheumatoid arthritis, the recommended dose is 15 mg once daily. For psoriatic arthritis, the recommended dose is 15 mg once daily. For non-radiographic axial spondyloarthritis, the recommended dose is 15 mg once daily. For ankylosing spondylitis, the recommended dose is 15 mg once daily. RINVOQ tablets should be taken orally with or without food and swallowed whole; they should not be split, crushed, or chewed.

Key safety warnings

In a large randomised post-marketing safety study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years of age and older with at least one additional cardiovascular risk factor, a higher rate of all-cause mortality was observed with tofacitinib compared to TNF inhibitors, mainly due to cardiovascular events, infections and malignancies. In patients 65 years of age and older, patients who are current or past long-time smokers and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. Serious and sometimes fatal events of thrombosis, including deep vein thrombosis (DVT), arterial thrombosis and pulmonary embolism (PE), have occurred in patients treated with JAK inhibitors, including upadacitinib. Promptly evaluate patients with signs and symptoms of venous thromboembolism and discontinue RINVOQ in patients with suspected venous thromboembolism, regardless of dose or indication. Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors including RINVOQ. A higher rate of malignancies, driven by non-melanoma skin cancer (NMSC), was observed with RINVOQ 30 mg compared to RINVOQ 15 mg. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis. A higher rate of serious infections was observed with RINVOQ 30 mg compared to RINVOQ 15 mg. Patients should be screened for tuberculosis before starting RINVOQ therapy, and RINVOQ should not be given to patients with active tuberculosis. Events of gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. RINVOQ must not be used in combination with biologic disease-modifying anti-rheumatic drugs (bDMARDs).

PBS listing

The 15 mg tablet strength is listed on the PBS with 15 items, restriction type authority required and streamlined, at an ex-manufacturer price of A$1092.47. The 30 mg tablet strength is listed with 7 items, restriction type authority required, at an ex-manufacturer price of A$1820.79. The 45 mg tablet strength is listed with 2 items, restriction type authority required, at an ex-manufacturer price of A$2427.11.

Regulatory history

RINVOQ upadacitinib 15 mg modified release tablet was first listed on the ARTG on 17 January 2020. The 30 mg strength was first listed on 20 September 2021 and the 45 mg strength was first listed on 20 September 2022. In November 2019, the PBAC recommended RINVOQ for rheumatoid arthritis as an Authority Required listing on a cost-minimisation basis to the least costly biological disease-modifying anti-rheumatic drug listed on the PBS for rheumatoid arthritis. In March 2021, the PBAC recommended listings for severe psoriatic arthritis and ankylosing spondylitis. In November 2022, the PBAC recommended listing for moderate to severe ulcerative colitis. In July 2023, the PBAC recommended listing for Crohn's disease. An AusPAR was published on 17 September 2021 for atopic dermatitis.