This document communicates safety updates for four different products based on reviewed safety signals.
1. Ciltabtagene autoleucel (Carvykti)
Safety Signal: Immune-mediated enterocolitis (EPITT no 20133)
Updates:
- SmPC Section 4.4 (Warnings):
- A warning states that patients may develop immune-mediated enterocolitis, which can emerge several months after infusion. Some cases may be resistant to corticosteroids, and there have been events of gastrointestinal perforation, including fatal outcomes.
- SmPC Section 4.8 (Undesirable Effects):
- Immune-mediated enterocolitis has been added with a frequency of “Common”.
- Package Leaflet:
- Immune-mediated enterocolitis is listed as a common side effect.
2. Brodalumab
Safety Signal: Pyoderma gangrenosum (EPITT no 20162)
Updates:
- SmPC Section 4.8 (Undesirable Effects):
- Pyoderma gangrenosum (a condition causing painful skin ulcers) has been added with a frequency of “Not known”.
- Package Leaflet:
- Painful swelling and skin ulceration (pyoderma gangrenosum) is listed as a side effect with frequency “Not known”.
3. Enzalutamide & Digoxin
Safety Signal: Laboratory test interference leading to falsely elevated digoxin levels (EPITT no 20134)
Updates:
- For Enzalutamide (SmPC):
- A new section warns that the chemiluminescent microparticle immunoassay (CMIA) can give falsely elevated digoxin levels in patients taking enzalutamide, even if they are not on digoxin. Results from this assay should be confirmed by another method before adjusting digoxin doses.
- For Digoxin (SmPC & Leaflet):
- Similar warnings are added about the potential for false-high digoxin levels when patients are also taking enzalutamide. Patients are advised to inform their doctor if they are taking enzalutamide.
4. Vortioxetine
Safety Signal: Hallucinations, not related to serotonin syndrome (EPITT no 20152)
Updates:
- SmPC Section 4.8 (Undesirable Effects):
- Hallucinations have been added as an adverse reaction with a frequency of “Uncommon”.
- Package Leaflet:
- Hallucinations are listed as an uncommon side effect.
Purpose
These updates ensure that healthcare professionals and patients are informed of new or clarified risks, including serious gastrointestinal conditions, severe skin reactions, critical laboratory test interferences, and psychiatric effects, to guide monitoring and ensure safe use of these medicines.
