Examples of EU/US Product Information for Biotechnology Products Potentially Containing Protein Particles
| Generic Name (Route of Administration) | Product Name | Product Information EU or US | Section | Text |
|---|---|---|---|---|
| Anakinra injection (subcutaneous) | Kineret | US | 2.4 Administration | There may be trace amounts of small, translucent-to-white amorphous particles of protein in the solution. If the number of translucent-to-white amorphous particles in a given syringe appears excessive, do not use this syringe. |
| 11 Description | The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. | |||
| Etanercept injection (subcutaneous) | Enbrel | EU | 6.6 Special precautions for disposal and other handling | The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein. |
| US | 2.4 Preparation of Enbrel | Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. | ||
| Denosumab injection (subcutaneous) | Prolia | EU | 6.6 Special precautions for disposal and other handling | The solution may contain trace amounts of translucent to white proteinaceous particles. Do not inject the solution if it is cloudy or discoloured. |
| US | 2.2 Preparation and Administration | Prolia is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. | ||
| Golimumab injection (intravenous) | Simponi ARIA | US | 2.3 Important Administration Instructions | The solution may develop a few fine translucent particles, as golimumab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present. |
| Ipilimumab injection (intravenous) | Yervoy injection | US | 2.3 Preparation and Administration | Discard vial if solution is cloudy, there is pronounced discoloration (solution may have a pale yellow color), or there is foreign particulate matter other than translucent-to-white, amorphous particles. |
| Infliximab for injection (intravenous) | Remicade | US | 2.11 General Considerations and Instructions for Preparation and Administration | The solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles, as infliximab is a protein. |
| Nivolumab injection (intravenous) | Opdivo | US | 2.3 Preparation and Administration | Visually inspect drug product solution for particulate matter and discoloration prior to administration. Opdivo is a clear to opalescent, colorless to pale-yellow solution. Discard the vial if the solution is cloudy, is discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles. |
| 11 Description | Opdivo is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale yellow liquid that may contain light (few) particles. | |||
| Panitumumab injection (intravenous) | Vectibix | US | 2.3 Preparation and Administration | Although Vectibix should be colorless, the solution may contain a small amount of visible translucent-to-white, amorphous, proteinaceous, panitumumab particulates (which will be removed by filtration). |
| Pembrolizumab for injection (intravenous) | Keytruda | US | 2.3 Preparation and Administration | Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. Reconstituted Keytruda is a clear to slightly opalescent, colorless to slightly yellow solution. Discard reconstituted vial if extraneous particulate matter other than translucent to white proteinaceous particles is observed. |
| Ustekinumab solution for injection (subcutaneous) | Stelara | EU | 6.6 Special precautions for disposal and other handling | The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present. |