Rinvoq Labeling Updated to Include Class Warnings Related to JAK Inhibitors

The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.

AbbVie has updated the prescribing information and medication guide for Rinvoq® (upadacitinib) to include additional information related to risks associated with systemically-administered Janus kinase (JAK) inhibitors used in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases.

The update follows the Food and Drug Administration’s (FDA) Drug Safety Communication issued on September 1, 2021, which was based on a completed review of a large randomized safety clinical trial (ClinicalTrials.gov Identifier: NCT02092467) evaluating tofacitinib (Xeljanz®) in 4362 RA patients. Final trial results showed an increased risk of major adverse cardiovascular events (MACE), death, malignancies, and thrombosis among patients treated with tofacitinib compared with those who received tumor necrosis factor (TNF) blockers. 

The updated labeling for Rinvoq now includes additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) in the Boxed Warning and Warnings and Precautions sections. The benefits and risks for the individual patient should be considered prior to initiating or continuing therapy with Rinvoq.

The indication for Rinvoq has also been updated to the following: Treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to 1 or more TNF blockers. Previously, the treatment was indicated for RA patients with an inadequate response or intolerance to methotrexate.

“Rinvoq is an important treatment option for people living with rheumatoid arthritis, especially those who have not been able to achieve remission or low disease activity,” said Michael Severino, MD, vice chairman and president, AbbVie. “We remain committed to continue generating evidence that support its benefit-risk profile across many inflammatory conditions.”

The FDA is currently reviewing the supplemental New Drug Applications for upadacitinib in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.


  1. AbbVie provides update on Rinvoq® (upadacitinib) for the treatment of rheumatoid arthritis in the US. News release. AbbVie. Accessed December 6, 2021. https://www.prnewswire.com/news-releases/abbvie-provides-update-on-rinvoq-upadacitinib-for-the-treatment-of-rheumatoid-arthritis-in-the-us-301437373.html
  2. Rinvoq. Package Insert. AbbVie Inc.; 2021. Accessed December 6, 2021. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf.