What is the infusion rate of Ferric Carboxymaltose (FCM), 1 gram mixed in 200 ml of Normal saline?

Ferric Carboxymaltose (FCM) 1 gram in 200 mL Normal Saline: Infusion Rate

Infuse FCM 1 gram diluted in 200 mL normal saline over 20-30 minutes, starting slowly for the first few minutes to monitor for reactions, then completing the remainder over the balance of the infusion time. 1

Recommended Administration Protocol

Dilution and Infusion Time

• FCM should be diluted in 100 mL of normal saline and infused over 20-30 minutes per the 2024 American Journal of Hematology expert consensus guidelines 1, 2
• Your preparation of 1 gram in 200 mL normal saline is acceptable, though slightly more dilute than the standard recommendation 1
• The minimum administration time for 1000 mg FCM is 15 minutes according to European Society of Cardiology guidelines 1

Infusion Technique

• Start the infusion slowly and observe the patient for several minutes 1
• If no reaction occurs during the initial observation period, infuse the remaining solution over the balance of 20-30 minutes 1
• The infusion rate translates to approximately 200 mL over 20-30 minutes, or 6.7-10 mL/minute for your preparation 1

Post-Infusion Monitoring

• Observe patients for adverse effects for at least 30 minutes following the infusion 1
• This monitoring period is critical for detecting hypersensitivity reactions, which occur at a frequency of ≥0.1% to <1.0% 1

Important Safety Considerations

Common Adverse Effects

• Most common side effects (1-10% frequency) include dizziness, headache, hypertension, hypophosphatemia, injection-site reactions, and nausea 1
• Flushing during injection is common, as is transient headache in subsequent weeks 3

Critical Caution: Hypophosphatemia

• FCM is associated with treatment-emergent hypophosphatemia and should be avoided in patients requiring repeat infusions 1, 2
• Hypophosphatemia rates with FCM are significantly higher (58%) compared to other formulations like iron derisomaltose (4%) or iron sucrose (1%) 2
• Most cases are biochemically moderate (serum phosphate 0.32-0.64 mmol/L) and asymptomatic, resolving without intervention 2

Contraindications

• Do not administer if hemoglobin >15 g/dL 2
• Contraindicated in patients with hypersensitivity to FCM or its excipients, known serious hypersensitivity to other parenteral iron products, anemia not attributed to iron deficiency, or evidence of iron overload 2
• Use with caution in patients with acute or chronic infection (stop treatment in patients with bacteremia) 2

Alternative Administration Methods

While the standard recommendation is dilution and infusion over 20-30 minutes, research has explored more rapid administration:

• A 2021 Phase II study demonstrated that undiluted FCM given as a rapid bolus injection was well tolerated with no serious adverse events in 121 patients 3
• However, this approach is not yet guideline-recommended and should be reserved for research settings 3

Follow-Up Monitoring

• Do not evaluate iron parameters within 4 weeks of administration as circulating iron interferes with assay results 2, 4
• Laboratory evaluation should include CBC and iron parameters (ferritin, transferrin saturation) at 4-8 weeks after infusion 2, 4
• Hemoglobin should increase within 1-2 weeks and rise by 1-2 g/dL within 4-8 weeks 2, 4