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At its September meeting, Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communication that will warn clinicians about the risk for severe adverse reactions in patients with hereditary fructose intolerance treated with a new intravenous formulation of Remsima (infliximab).
The upcoming formulation of the biosimilar Remsima is a concentrate for solution for infusion that contains sorbitol, which is contraindicated in people with hereditary fructose intolerance due to the risk for serious and potentially fatal reactions. Even small amounts of intravenous sorbitol can lead to acute liver failure, hypoglycemia, excessive bleeding, kidney failure, and death in affected patients.
Remsima is approved for the treatment of several inflammatory conditions, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Healthcare professionals must verify that patients do not have hereditary fructose intolerance before initiating treatment with the upcoming Remsima concentrate for solution for infusion. The product information and patient reminder card for Remsima will be updated to include this new safety information.
New Formulation Under Review
The upcoming formulation is currently being evaluated by the European Medicines Agency's Committee for Medicinal Products for Human Use. Once approved, this concentrate will replace the current powder formulation, which needs to be reconstituted into a solution for infusion and does not contain sorbitol.
Remsima is also available as a subcutaneous solution for injection in prefilled syringes or pens. Although this subcutaneous formulation also includes sorbitol, it is considered safe for patients with hereditary fructose intolerance.
Hereditary fructose intolerance is very rare, affecting approximately 1 in 20,000 to 30,000 people globally. Most people taking Remsima won’t have the condition, but the safety communication will emphasize the critical importance of screening for it before intravenously administering medications containing sorbitol.
