Health Canada announces that it completed a safety review that confirmed a link between the use of Xeljanz/Xeljanz XR (tofacitinib) and the increased risks of serious heart-related problems and cancer, especially in older patients, patients who are current or past smokers, and patients with cardiovascular or cancer risk factors. Health Canada’s review also found that all patients treated with Xeljanz 10 mg twice daily had a higher risk of death, blood clots and serious infections, compared to patients treated with Xeljanz 5 mg twice daily or tumour necrosis factor inhibitors.
As a result, Health Canada has worked with the manufacturer to update the product labels to further strengthen the warnings on the risks of serious heart-related problems and cancer. Healthcare professionals have been informed of these updates in order to advise their patients.
To ensure the benefits outweigh the risks in patients receiving Xeljanz/Xeljanz XR, the approved use for rheumatoid arthritis is now limited to certain patients who are unable to use other drugs for this condition or when at least two different other drugs do not work. The higher dose of Xeljanz 10 mg twice daily is only authorized for patients with ulcerative colitis who have not responded well to other medications. For patients with ulcerative colitis, the prescribing information recommends that they use the lowest effective dose and for the shortest duration needed to help them improve their condition.
Healthcare professionals are advised:
- Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Xeljanz/Xeljanz XR, particularly in geriatric patients, in patients who are current or past smokers, those with other cardiovascular or malignancy risk factors, those who develop a malignancy, and those with a known malignancy other than a successfully treated non-melanoma skin cancer.
- Inform patients that Xeljanz/Xeljanz XR may increase their risk of major adverse cardiovascular events including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current or past smokers, or patients with other cardiovascular risk factors, to be alert for signs and symptoms of cardiovascular events.
- Inform patients that Xeljanz/Xeljanz XR may increase their risk of certain cancers, and that lung cancer, lymphoma and other cancers have been observed in patients taking Xeljanz. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.
- Advise patients to stop taking Xeljanz/Xeljanz XR and to call their healthcare professional right away if they experience any symptoms of thrombosis (sudden shortness of breath, chest pain worsened with breathing, swelling of leg or arm, leg pain or tenderness, red or discoloured skin in the affected leg or arm).
- Avoid Xeljanz/Xeljanz XR in patients who may be at increased risk of thrombosis.
- Closely monitor patients for signs and symptoms of infection during and after treatment with Xeljanz/Xeljanz XR.
- Xeljanz/Xeljanz XR should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. If a patient develops a new infection during treatment with Xeljanz/Xeljanz XR, they should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.
- Use Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily for the treatment of rheumatoid arthritis, and Xeljanz 5 mg twice daily for the treatment of psoriatic arthritis. Health Canada has not authorized the sale of the higher dose of 10 mg twice daily for rheumatoid arthritis or psoriatic arthritis.
- In patients with ulcerative colitis, use Xeljanz at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
- Be aware that the indication for Xeljanz/Xeljanz XR in rheumatoid arthritis patients is now limited to certain patients who have not responded well to other medications.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/health-canada-safety-review-finds-link-between-use-xeljanz-and-xeljanz-xr-tofacitinib
In Hong Kong, there are 3 registered pharmaceutical products containing tofacitinib, namely Xeljanz Tablets 5mg (HK-63303), Xeljanz XR Extended Release Tablets 11mg (HK-66141) and Xeljanz Tablets 10mg (HK-66833). All products are registered by Pfizer Corporation Hong Kong Limited. They are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to tofacitinib, of which one case was related to lung cancer, 3 cases were related to deep vein thrombosis, one case was related to pneumonia, one case was related to herpes zoster disseminated, one case was related to cellulitis and one case was related to disseminated tuberculosis.
Related news on the risk of blood clots and death of tofacitinib was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 26 Feb 2019, with the latest update posted on 2 Sep 2021. Letters to inform local healthcare professionals were issued by the DH on 29 Jul 2019 and 19 Jun 2020. In Dec 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of tofacitinib products should include safety information about increased risk of blood clots and death with higher dose (10 mg twice daily).
Related news on the risk of serious heart-related problems and cancer of tofacitinib was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Feb 2021, with the latest update posted on 7 Oct 2021. Letters to inform local healthcare professionals were issued by the DH on 15 Jun 2021. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Jan 13, 2022
Issued at HKT 16:00
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