New product information wording – Extracts from PRAC – October 2025

This document is a supplementary publication from the European Medicines Agency (EMA). It provides the exact legal wording that must be inserted into the official product information for medicines, based on the safety recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) during its October 2025 meeting.

1. Purpose and Nature of the Document

• Primary Function: To serve as the definitive, standardized text for Marketing Authorisation Holders (MAHs) to use when updating their Summary of Product Characteristics (SmPC – for healthcare professionals) and Package Leaflet (for patients).
• Format: It is an extract. The full context and procedural instructions are in the main “PRAC recommendations on signals” document.
• Key Visual Cue: New text to be added is underlined. Text to be deleted (if any) is shown as struck-through (though none appear in these specific extracts).

2. Detailed Breakdown of Required Updates

The document specifies changes for three medicines, corresponding to the PRAC’s “updates to product information” recommendations.

A. Bosutinib – Addition of “Cutaneous Vasculitis” as a Side Effect

• Change to SmPC (Section 4.8):
  • Under “Skin and subcutaneous tissue disorders,” the term “Cutaneous vasculitis” must be added with the frequency category “Uncommon” (affects up to 1 in 100 people).
• Change to Package Leaflet (Section 4):
  • A patient-friendly description must be added: “Inflammation of blood vessels in the skin which may result in a rash or bruising (cutaneous vasculitis).” It is also categorized as “Uncommon.”
• Impact: Informs prescribers and patients that this skin condition is a recognized possible side effect of the medicine.

B. Datopotamab Deruxtecan (“Datroway”) – Addition of Warnings for Anaphylaxis

• Changes to SmPC:
  1. Section 4.4 (Warnings): A new warning paragraph is added. It states that serious anaphylactic reactions have occurred, mandates close patient observation during infusion, requires emergency equipment to be on hand, and instructs that treatment must be permanently discontinued in case of a serious reaction.
  2. Section 4.8 (Side Effects): “Anaphylactic reaction” is added to the table of adverse reactions under “Immune system disorders” with a frequency of “Not known.”
• Changes to Package Leaflet:
  1. Section 2 (Warnings): A clear warning is added for patients about the risk of serious allergic reactions during or after infusion. It states the doctor will monitor them closely and that treatment will be stopped permanently for a serious reaction.
  2. Section 4 (Side Effects): Under the “Not known” frequency category, a detailed list of anaphylaxis symptoms (rash, swelling, breathing difficulty, low blood pressure, etc.) is provided, advising patients to seek immediate medical help.
• Impact: Significantly strengthens the safety warnings for this cancer therapy, ensuring both medical teams and patients are aware of the potential for severe allergic reactions and the required emergency response.

C. Epcoritamab (“Tepkinly”) – Addition of Warnings and Monitoring for Low Antibodies (Hypogammaglobulinaemia)

• Changes to SmPC:
  1. Section 4.4 (Warnings): Text is added to the “Serious infections” warning stating that hypogammaglobulinaemia has been reported. It mandates that immunoglobulin (Ig) levels should be monitored before and during treatment and that patients should be managed with infection precautions.
  2. Section 4.8 (Side Effects): “Hypogammaglobulinaemia” is added to the table under “Immune system disorders.” Its frequency is “Very common” for all grades (affects more than 1 in 10 people) and “Uncommon” for severe (Grade 3-4) cases.
• Changes to Package Leaflet:
  1. Section 2 (Warnings): Informs patients that their doctor will perform blood tests before and during treatment to check their antibody levels, which helps assess infection risk.
  2. Section 4 (Side Effects): Under “Very common” side effects, it lists “low levels of immunoglobulins, which may lead to infections” as a finding shown in blood tests.
• Impact: Establishes a new standard of care for patients on this lymphoma treatment, requiring proactive monitoring of immune function to prevent and manage associated infections.

Conclusion

This document translates the PRAC’s safety conclusions into actionable, regulatory text. It ensures that all manufacturers of the affected medicines implement identical warnings and information across the European Union, guaranteeing consistency and clarity for healthcare professionals and patients regarding these newly confirmed risks. The updates range from adding a new side effect to introducing critical monitoring requirements and emergency protocols.