Reconstitution of Ferric Carboxymaltose (Iron) Solution
Ferric carboxymaltose should be diluted in sterile 0.9% sodium chloride solution and infused over 15-30 minutes, with specific dilution ratios based on the dose being administered. 1
Dilution Protocol
For a 500 mg dose:
- Use 10 mL of ferric carboxymaltose
- Dilute in up to 100 mL of sterile 0.9% sodium chloride solution
- Infuse over a minimum of 6 minutes 1
For a 1000 mg dose:
- Use 20 mL of ferric carboxymaltose
- Dilute in up to 250 mL of sterile 0.9% sodium chloride solution
- Infuse over a minimum of 15 minutes 1
Administration Guidelines
- The maximum recommended cumulative dose is 1000 mg of iron (20 mL ferric carboxymaltose) per week 1
- In the United States, ferric carboxymaltose is distributed as a 750 mg vial with a label recommending two doses 1 week apart 1
- The infusion should start slowly and be observed for several minutes before increasing to the full rate 1
- Patients should be observed for adverse effects for at least 30 minutes following each IV injection 1
Important Considerations
- Avoid over-dilution of the solution as this may affect stability 1
- In case of paravenous leakage (extravasation), administration must be stopped immediately to prevent skin staining or discoloration at the infusion site 1
- Ferric carboxymaltose can be administered in hospital or community settings where staff are trained to monitor for and manage hypersensitivity reactions 1
- The risk of hypersensitivity reactions with IV ferric carboxymaltose is low (0.1% to <1.0%) 1
Post-Administration Monitoring
- Iron status should not be evaluated within 4 weeks of administration as ferritin levels increase markedly following IV iron administration 1, 2
- Laboratory evaluation following IV iron should include a complete blood count and iron parameters (ferritin, percent transferrin saturation) 4-8 weeks after the last infusion 1, 2
By following these reconstitution and administration guidelines, ferric carboxymaltose can be safely delivered to patients requiring iron supplementation while minimizing the risk of adverse events.