其 他 安 全 警 示
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| European Union: Remsima (infliximab): new intravenous formulation contraindicated in patients with hereditary fructose intolerance (English only) |
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Remsima is a biosimilar medicine containing infliximab and is used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
The Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) about a new intravenous formulation of Remsima that must not be given to people with hereditary fructose intolerance (HFI) as it contains sorbitol. In people with HFI, even small amounts of sorbitol given intravenously can result in severe and potentially life-threatening adverse reactions, including hypoglycaemia (low blood glucose levels), acute liver failure, haemorrhagic syndrome (excessive bleeding), kidney failure and death.
The new formulation is a concentrate for solution for infusion under evaluation by EMA’s human medicines committee (CHMP). Once approved, it will replace the existing formulation of a powder to be made up into a solution for infusion which does not contain sorbitol. Remsima is also available as a subcutaneous solution for injection in a prefilled syringe or pen. Although this subcutaneous formulation also contains sorbitol, it is considered safe for people with HFI.
Before starting treatment with the new Remsima concentrate for solution for infusion, healthcare professionals must confirm that the patient does not have hereditary fructose intolerance. The product information and patient reminder card for Remsima will be updated to reflect this new information.
The DHPC for Remsima will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the direct healthcare professional communications page and/or in national registers in EU Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025
In Hong Kong, there are 3 registered products containing infliximab and under the brand name Remsima that are registered by Celltrion Healthcare Hong Kong Limited., and are prescription-only medicines. The new formulation of a concentrate for solution for infusion is not a registered pharmaceutical product in Hong Kong.
Ends/ Saturday, September 06, 2025
Issued at HKT 12:30
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