Limited coverage criteria – ferric carboxymaltose for iron deficiency anemia

Last updated on April 8, 2026

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Generic name		ferric carboxymaltose
Strength & form		50 mg/mL vial (100 mg/2 mL, 500 mg/10 mL, 1000 mg/20 mL)

Special Authority criteria	Approval period
For the treatment of patients 1 year and older with iron deficiency anemia (IDA) when ALL of the following criteria are met: Patient has a documented diagnosis of IDA confirmed by laboratory testing results (e.g., hemoglobin, ferritin, transferrin saturation) AND Either ONE of the following: Patient has failed to respond to an adequate trial of at least one oral iron therapy, which requires a minimum 4 week trial period¹, OR Patient is intolerant to at least two oral iron therapies, OR Patient has a contraindication to oral iron therapy AND Ferric carboxymaltose is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided	Initial: One course of treatment up to a maximum of 2,000 mg per course that must be filled within 28 days² Renewal: One course of treatment at a minimum of 4 weeks after the dispense of the initial dose²

Special Authority criteria

Approval period

For the treatment of patients 1 year and older with iron deficiency anemia (IDA) when ALL of the following criteria are met:

Patient has a documented diagnosis of IDA confirmed by laboratory testing results (e.g., hemoglobin, ferritin, transferrin saturation)

AND

Either ONE of the following:
- Patient has failed to respond to an adequate trial of at least one oral iron therapy, which requires a minimum 4 week trial period¹, OR
- Patient is intolerant to at least two oral iron therapies, OR
- Patient has a contraindication to oral iron therapy

AND

Ferric carboxymaltose is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided

Initial: One course of treatment up to a maximum of 2,000 mg per course that must be filled within 28 days²

Renewal: One course of treatment at a minimum of 4 weeks after the dispense of the initial dose²

Practitioner exemptions

None

Special notes

¹Defined as a therapeutic dose of oral iron intended for the treatment (not prophylaxis) of IDA
²The individual iron need for repletion using Ferinject is determined based on the patient's body weight and hemoglobin (Hb) level. The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL ferric carboxymaltose) per week. For pediatric patients aged 1 to 17 years, the maximum recommended cumulative dose of Ferinject is 750 mg of iron (15 mL ferric carboxymaltose) per week. If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days after the first dose. As per the product monograph, re-assessment for iron repletion 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 Ferinject administration. In the event the patient requires further iron repletion, the iron need should be recalculated

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