其 他 安 全 警 示
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| The United Kingdom: Baricitinib (Olumiant▼): risk of venous thromboembolism (English only) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces the risk of venous thromboembolism of baricitinib.
In Apr 2017, clinical trial findings showed an imbalance in cases of deep vein thrombosis and pulmonary embolism with baricitinib treatment compared with placebo. The exposure-adjusted incidence rate for venous thromboembolism was 0 for placebo compared with 1.3 events per 100 patient-years of exposure for baricitinib 4mg. However, at the time a causal link could not be fully established due to the presence of confounding factors. Based on the data, a warning was added to recommend that baricitinib be used with caution in patients with risk factors for deep vein thrombosis and pulmonary embolism and that if patients experience signs of venous thromboembolism, treatment should be temporarily interrupted and patients should be evaluated promptly.
Following findings of an increased risk of pulmonary embolism in an ongoing study with another JAK inhibitor, tofacitinib, a recent European cumulative review reassessed the evidence for risk with baricitinib. The advice has now been updated to recommend discontinuation of baricitinib if clinical signs of venous thromboembolism occur.
Cumulatively, there have been 102 cases of venous thromboembolism events reported post-marketing worldwide since marketing. Some of these reports contained more than one thromboembolic event and within these cases there were 63 events of pulmonary embolism and 51 events of deep vein thrombosis. Cumulatively, as of 31 Jul 2019, there have been an estimated 95,100 patients exposed to baricitinib and 42,800 patient years of exposure. There was no consistent pattern in time to onset of venous thromboembolism (where provided) but most cases occurred between 6–12 months after initiation.
In one case, the patient continued baricitinib treatment after experiencing a deep vein thrombosis. It was later reported that the patient had a recurrent venous thromboembolism and subsequently a pulmonary embolism. Baricitinib treatment was then permanently discontinued.
Upadacitinib (Rinvoq▼) was recently approved for use in the European Union. Deep venous thrombosis and pulmonary embolism events have been reported in patients taking upadacitinib. Like tofacitinib and baricitinib, upadacitinib should be used with caution in patients at high risk for venous thromboembolism. If features of deep venous thrombosis and pulmonary embolism occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Healthcare professionals are advised:
- Clinical trial data show a greater frequency of venous thromboembolism events with baricitinib compared with placebo – deep vein thrombosis and pulmonary embolism events are considered to be uncommon with baricitinib (up to 1 in 100 patients).
- Use caution if considering baricitinib in patients with additional risk factors for deep vein thrombosis and pulmonary embolism, such as prior medical history of venous thromboembolism, surgery, immobilisation, older age, and obesity.
- Discontinue baricitinib treatment permanently if clinical features of venous thromboembolism occur.
- Advise patients undergoing treatment with baricitinib to seek urgent medical attention if they experience a painful swollen leg, chest pain, or shortness of breath.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/baricitinib-olumiant-risk-of-venous-thromboembolism
In Hong Kong, Olumiant Tablets 2mg (HK-65663) and Olumiant Tablets 4mg (HK-65664) are registered pharmaceutical products containing baricitinib. Both products are registered by Eli Lilly Asia, Inc. (Eli Lilly), and are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to baricitinib. The current local product inserts already contain safety information on the risk of venous thromboembolism. In Feb 2020, Eli Lilly submitted an application for updating the local product inserts to include the discontinuation of baricitinib if clinical signs of venous thromboembolism occur. The DH will continue to work with the company to update the relevant product information and remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
There is no registered pharmaceutical product containing upadacitinib.
Ends/Thursday, Mar 19, 2020
Issued at HKT 17:30
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