Kyprolis Visible Particles After Reconstitution - Safety Communication
Summary
Swissmedic issued a health professional communication regarding Kyprolis (carfilzomibum) 10 mg and 60 mg following routine stability monitoring that detected visible particles (transparent, colorless) in reconstituted samples. All distributed batches remain safe for use. The communication emphasizes strict adherence to visual inspection procedures per approved reconstitution instructions before administration.
What changed
Swissmedic issued a Direct Healthcare Professional Communication for Kyprolis (carfilzomibum) after routine stability monitoring revealed visible particles in reconstituted samples. The particles were described as transparent and colorless. All currently distributed batches of both 10 mg and 60 mg presentations can continue to be used safely. The communication does not constitute a recall but serves to reinforce the critical importance of visual inspection according to approved reconstitution instructions.
Healthcare providers and pharmaceutical professionals should verify that reconstitution procedures are being performed exactly as specified in the approved product information. Visual inspection of the reconstituted solution must be conducted prior to patient administration. Manufacturers and healthcare facilities handling this product should review their reconstitution and inspection protocols to ensure compliance with approved instructions.
What to do next
- Verify reconstitution procedures match approved product information
- Perform visual inspection of reconstituted Kyprolis before administration
- Contact Amgen Switzerland AG for further information
Archived snapshot
Apr 15, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
DHPC – Kyprolis® (carfilzomibum)
Potentielle sichtbare Partikel nach Rekonstitution
14.04.2026
| Präparat | Kyprolis 10 mg und 60 mg, Pulver zur Herstellung einer Infusionslösung |
|---|---|
| Zulassungsnummer | 65690 |
| Wirkstoff | carfilzomibum |
| Zulassungsinhaberin | Amgen Switzerland AG |
| Betroffene Chargen | alle |
Im Rahmen der routinemässigen Stabilitätsüberwachung wurden sichtbare Partikel (durchscheinend und farblos) in rekonstituierten Proben von Kyprolis 10 mg/Durchstechflasche festgestellt. Alle ausgelieferten Chargen von Kyprolis 10 mg und 60 mg Durchstechflaschen können weiterhin sicher verwendet werden. Medizinisches Fachpersonal kann das Produkt gemäss der zugelassenen Fachinformation weiterhin anwenden. Diese Mitteilung soll die Bedeutung der visuellen Inspektion vor der Anwendung gemäss den zugelassenen Rekonstitutionsanweisungen hervorheben.
Weitere Informationen entnehmen Sie bitte dem Informationsschreiben der Firma.
- Company information letter
DHPC – Kyprolis® (carfilzomibum) (PDF, 159 kB, 14.04.2026)
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