The Institute for Safe Medication Practices (ISMP), an affiliate of ECRI, has raised concerns about potential medication errors involving two biologic drugs approved by the Food and Drug Administration (FDA). Both Inflectra and Zymfentra share the nonproprietary name inFLIXimab-dyyb, though they are not biosimilars or interchangeable with each other.
Inflectra is a biosimilar of Remicade and is available as a 100 mg lyophilized powder. It is approved for various conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Zymfentra differs as it comes in 120 mg/mL prefilled syringes and pens. It is intended for maintenance treatment of Crohn’s disease or ulcerative colitis following intravenous administration of an inFLIXimab product.
The ISMP highlighted that this situation marks the first instance where two brand-name products share the same nonproprietary name and four-letter suffix. Specialty pharmacies may stock both Inflectra and Zymfentra. However, confusion can arise if Inflectra's lyophilized powder is sent to patients instead of Zymfentra's subcutaneous formulation or vice versa.
To mitigate these risks, ISMP recommends several measures. They have informed the FDA and Celltrion, Inc., the manufacturer of both drugs, about potential mix-ups. Recommendations include listing these medications as separate products in electronic systems, using brand names when prescribing them, verifying dosage forms in pharmacies, educating staff on product differences, checking medications at points of sale or upon receipt by patients.
"Safe Practice Recommendations" from ISMP emphasize confirming with computer and drug information vendors that these drugs are listed separately in systems to reduce errors. The organization advises that electronic prescribing systems should associate order sentences with the correct product. Staff should be educated on differences between the products to avoid interchangeability issues.
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