引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| European Union: New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome (English only) |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) recommended new measures to reduce the risk of respiratory failure and sepsis when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (type 1 HRS) on 29 Sep 2022.
The new measures include adding to the product information a warning to avoid using terlipressin-containing medicines in patients with advanced acute-on-chronic liver disease or advanced kidney failure. Patients with breathing problems should receive treatment to manage their condition before starting terlipressin-containing medicines. During and after treatment, patients should be monitored for signs and symptoms of respiratory failure and infection. In addition, healthcare professionals can consider giving terlipressin-containing medicines as a continuous infusion into the vein as an alternative to giving it by bolus injection as this may reduce the risk of severe side effects.
The recommendations follow the PRAC’s review of available data, including results from a clinical trial involving patients with type 1 HRS which suggested that patients who were treated with terlipressin-containing medicines were more likely to experience and die from respiratory disorders within 90 days after the first dose than those who were given placebo. Although respiratory failure is a known side effect of terlipressin-containing medicines, the frequency of respiratory failure seen in the study was higher (11%) than previously reported in the product information. In addition, the study reported sepsis in 7% of patients in the terlipressin arm compared with none in the placebo group.
There were limitations to the data, such as differences in how terlipressin was used in the clinical trials compared to clinical practice. After considering these limitations together with other available data and consulting an expert group composed of healthcare professionals with expertise in the field of hepatorenal syndrome, PRAC concluded that new measures were needed to ensure that the benefits of terlipressin-containing medicines continue to outweigh the risks.
The PRAC recommendations were sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which endorsed them and adopted its position on 10 Nov 2022.
Information for healthcare professionals:
- A higher than previously known risk of respiratory failure has been reported when using terlipressin-containing medicines for the treatment of type 1 HRS). In addition, a new risk of sepsis has been identified with the use of terlipressin-containing medicines for treating this disease.
- Terlipressin-containing medicines should be avoided in patients with advanced renal dysfunction (serum creatinine ≥ 442µmol/l (5.0 mg/dl)) and in patients with acute-on-chronic liver failure grade 3 and/or model for end-stage liver disease (MELD) score ≥39 MELD score, unless the benefits outweigh the risks.
- Patients with new onset of breathing difficulties or worsening of existing respiratory disease should be stabilized before treatment with terlipressin-containing medicines and should be closely monitored during treatment. If patients develop respiratory symptoms, a dose reduction of human albumin should be considered, if applicable. If symptoms are severe or do not resolve, terlipressin-containing medicines should be discontinued.
- Patients should be closely monitored for symptoms of infection.
- In addition, healthcare professionals can consider giving terlipressin-containing medicines as a continuous intravenous infusion as an alternative to bolus injection, as continuous infusion may reduce the risk of severe adverse events compared to bolus injection.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/new-recommendations-terlipressin-containing-medicines-treatment-hepatorenal-syndrome-0
In Hong Kong, there are 4 registered pharmaceutical products containing terlipressin. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to terlipressin. Related news was previously issued by EMA, and was posted on the Drug Office website on 15 Jan 2022 and 3 Oct 2022. Letters to inform local healthcare professionals were issued by the DH on 3 Oct 2022. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Nov 12, 2022
Issued at HKT 12:00
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