Iron deficiency

The posology of ferric carboxymaltose follows a stepwise approach:
¹ determination of the individual iron need,
² calculation and administration of the iron dose(s), and
³ post-iron repletion assessments.

Step 1: Determination of the iron need

The individual iron need for repletion using ferric carboxymaltose is determined based on the patient’s body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the iron need:

Table 1. Determination of the iron need:

Iron deficiency must be confirmed by laboratory tests.

Step 2: Calculation and administration of the maximum individual iron dose(s)

Based on the iron need determined above the appropriate dose(s) of ferric carboxymaltose should be administered taking into consideration the following:

A single ferric carboxymaltose administration should not exceed:

• 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
• 1,000 mg of iron (20 mL ferric carboxymaltose)

The maximum recommended cumulative dose of ferric carboxymaltose is 1,000 mg of iron (20 mL ferric carboxymaltose) per week.

Step 3: Post-iron repletion assessments

Re-assessment should be performed by the clinician based on the individual patient’s condition. The Hb level should be re-assessed no earlier than 4 weeks post final ferric carboxymaltose administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 above.

Ferric carboxymaltose must only be administered by the intravenous route:

• by injection, or
• by infusion, or
• during a haemodialysis session undiluted directly into the venous limb of the dialyser.

It must not be administered by the subcutaneous or intramuscular route.