Limited coverage drugs – iron isomaltoside

Generic name

iron isomaltoside


100 mg/mL



Special Authority criteria

Approval period

For the treatment of adult patients with iron deficiency anemia (IDA) who meet the following criteria:

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


  • 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 of 4 weeks trial period


  • Patient is intolerant to at least two oral iron therapies


  • Patient has contraindication to oral iron therapy


  • Iron isomaltoside must be administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the patient

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

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

Practitioner exemptions

  • None

Special notes

  • None

Special Authority request form(s)