The Product Information and Consumer Medicine Information documents for tofacitinib have been updated to include information about an increased risk of blood clots and of death when used at the higher dose (10 mg twice daily).
Tofacitinib is marketed in Australia under the brand name Xeljanz, and is used to treat adults with rheumatoid arthritis, psoriatic arthritis or ulcerative colitis.
As described below, the changes have been made in response to recent results from an ongoing safety study. To participate in the study, patients had to be at least 50 years of age and have at least one additional cardiovascular risk factor.
Health professionals are advised that the 10 mg twice daily dose is not approved in Australia for the treatment of rheumatoid arthritis or psoriatic arthritis.
The 10 mg twice daily dose is approved in Australia only for adult patients with moderately to severely active ulcerative colitis (UC). It should not be used as a first-line treatment, meaning patients will be prescribed other medicines first and will only receive this dose of tofacitinib if they do not respond well enough or are intolerant to those other treatments. Additionally, with UC patients, tofacitinib should be used at the lowest effective dose for the shortest duration needed.
Clinical study finds increased risk of blood clots in the lungs and of death in rheumatoid arthritis patients on high dose
21 March 2019
Consumers and health professionals are advised that the TGA is closely monitoring a safety issue relating to tofacitinib, which is marketed in Australia under the brand name Xeljanz.
The sponsor, Pfizer Australia, is writing to doctors to advise that a clinical trial has found an increased risk of blood clots in the lungs and overall mortality when a 10 mg twice daily dose of tofacitinib is used in patients with rheumatoid arthritis (compared to trial participants taking a 5 mg twice daily dose).
Patients participating in the study are being transitioned to a 5 mg twice daily dose.
The study was designed to assess the risk of cardiovascular events (for example, heart attack, coronary artery disease, heart failure and abnormal heart rhythms) in patients aged at least 50 years who had at least one other cardiovascular risk factor. All participants who entered the study had previously been treated with methotrexate.
The increased risk of blood clots in the lungs and overall mortality identified in this study has not been identified in other clinical trials or routine monitoring of post-market safety data, such as adverse event reports.
Please note that a 10 mg twice daily dose is not approved for treatment of rheumatoid arthritis in Australia. However, that dose is approved in Australia for the initial and short-term treatment of adult patients with moderately to severely active ulcerative colitis. It is not recommended as a first-line treatment, meaning it is approved for use in ulcerative colitis patients for whom other treatments are not appropriate, have not worked, or have lost effectiveness.
Pfizer Australia is continuing to work with regulatory agencies, including the TGA, to investigate this issue.
Information for consumers
If you or someone you provide care for takes tofacitinib, please be aware of this issue.
Patients should not stop taking their medicine or alter their dose unless instructed to do so by a doctor.
However, you should seek medical attention immediately if you experience any signs or symptoms of blood clots in your lungs or other unusual symptoms, including:
- sudden shortness of breath or difficulty breathing
- chest pain or pain in your back
- coughing up blood
- excessive sweating
- clammy or bluish-coloured skin.
If you have any questions or concerns about this issue, talk to your health professional.
Information for health professionals
If you are treating patients who are taking tofacitinib, please be aware of this issue.
You should refer to and follow the recommendations outlined in the PI in relation to the specific conditions for which tofacitinib is being used.
Monitor patients for signs and symptoms of pulmonary embolism and advise them to seek medical attention immediately if they experience them.
If you have any questions or concerns about this issue, contact Pfizer Australia on 1800 675 229.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.