Therapeutic Goods Administration (TGA) is advising consumers and health professionals that it 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 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.
Consumers are advised that if they or someone they 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, they should seek medical attention immediately if they experience any signs or symptoms of blood clots in their lungs or other unusual symptoms, including: sudden shortness of breath or difficulty breathing, chest pain or pain in the back, coughing up blood, excessive sweating, clammy or bluish-coloured skin.
Health professionals are advised that if they are treating patients who are taking tofacitinib, please be aware of this issue. They should refer to and follow the recommendations outlined in the Product Information 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/tofacitinib
In Hong Kong, Xeljanz Tablets 5mg (HK-63303) and Xeljanz XR Extended Release Tablets 11mg (HK-66141) are registered pharmaceutical products containing tofacitinib. Both products are registered by Pfizer Corporation Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to tofacitinib, but these cases are not related to blood clots in the lungs. Related news was previously issued by the US Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 26 Feb 2019 and 16 Mar 2019 respectively. As the clinical trial is ongoing, the DH will remain vigilant on the results of the trial and safety update of the drug issued by various overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Mar 21, 2019
Issued at HKT 16:00
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