Health Canada announces that drug-induced liver injury (DILI) in the form of transient and clinically silent elevations in transaminases has been commonly reported in patients treated with ESBRIET (pirfenidone). Rare DILI cases have been associated with serious clinical consequences including isolated cases with fatal outcome.
Serious hepatic adverse events including isolated cases with fatal outcome have recently been reported in the post-market setting in idiopathic pulmonary fibrosis (IPF) patients treated with ESBRIET. The majority of the reported hepatic events occurred within the first 6 months of treatment. No alternative etiologies or confounding factors could be found in these reports, which were therefore deemed clinically relevant cases of DILI. In the absence of a plausible pharmacodynamic mechanism, these cases appear possibly triggered by idiosyncratic reactions to pirfenidone.
Information for consumers:
- ESBRIET is a prescription medicine used to treat IPF in adults. IPF is a condition in which the tissue in the lungs becomes scarred over time, making it difficult to breathe.
- In some patients, ESBRIET has been associated with DILI, which can be serious and life-threatening.
- Before taking ESBRIET, patients should talk to their healthcare professional if they have, or have had, liver problems. ESBRIET may cause liver problems and other abnormal blood test results. Patients with severe or end-stage liver disease should not use ESBRIET. ESBRIET should be used with caution and careful monitoring in patients with mild or moderate liver issues. Before and during treatment, patients should have blood tests done to check their liver function.
- If patients experience signs of liver injury such as, tiredness, yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, or loss of appetite, they need to stop taking ESBRIET and seek immediate medical attention.
Healthcare professionals are advised to:
- Perform liver function tests (ALT, AST, and bilirubin) before initiating treatment with ESBRIET, subsequently at monthly intervals for the first 6 months, and then every 3 months thereafter.
- Promptly measure liver function tests in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
- Consider discontinuation or dose adjustments in the event of liver enzyme elevation.
- Not use ESBRIET in patients with severe hepatic impairment or end-stage liver disease.
- Use ESBRIET with caution in patients with pre existing mild to moderate hepatic impairment (Child-Pugh Class A and B).
The Canadian Product Monograph (CPM) for ESBRIET has been updated to include this new safety information.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../73905a-eng.php
In Hong Kong, Esbriet Capsules 267mg (HK-64288) is a registered pharmaceutical product containing pirfenidone. The product is registered by Roche Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received one case of adverse drug reaction related to pirfenidone, but this case is not related to liver injury. Related news was previously issued by Singapore Health Sciences Authority, and was posted on the Drug Office website on 19 Dec 2019. Letters to inform local healthcare professionals were issued by the DH on the same day. In light of the above Health Canada’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Sep 15, 2020
Issued at HKT 15:00
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