ROYAL HOBART HOSPITAL

DEPARTMENT OF PHARMACY

TOPIC: Ferric Carboxymaltose (Ferinject) – A NEW I.V. Iron Formulation

Target Audience: All Clinical Staff

Background:

1.  Ferric carboxymaltose is an alternative treatment to IV iron polymaltose for iron deficiency anaemia in patients who are intolerant or unresponsive to oral iron preparations and for patients who require rapid iron repletion.

2.  Ferric carboxymaltose is now listed on the Pharmaceutical Benefits Scheme (PBS) as an unrestricted benefit for iron deficiency anaemia.

3.  The Tasmanian Medicines Formulary has approved the use of ferric carboxymaltose in the following setting:

Outpatient:

Ø  PBS indication and quantities

Ø  500mg/10mL ampoules

Ø  Qty: 2

Ø  Rpt: 1

Inpatient:

Ø  For use in iron deficiency anaemiafor women in the second or third trimester of pregnancy where the benefits of treatment are deemed to outweigh the risks to the foetus.

Ø  For use in patients with known and documented intolerance/allergy to iron polymaltose.

Ø  For use on day of discharge from hospital according to the PBS indication and quantities.

4.  Prescribers will be required to supply a PBS prescription for all outpatients and any inpatients on day of discharge from the hospital.

Dose and administration:

1.  High dose infusion: single dose up to 1000mg iron (not exceeding 20mg/Kg).

2.  Dosage: It is expected that a single ferric carboxymaltose infusion will suffice for most patients. The following doses are suggested based on body weight:

Ø  55Kg or less: 500mg elemental iron (as ferric carboxymaltose)

Ø  55Kg or more: 1000mg elemental iron ( as ferric carboxymaltose)

If the patient requires more iron than a single dose can provide, please contact Pharmacy.

3.  No test dose is required.

4.  Ampoules: 500mg/10mL. Ordered through Pharmacy Department (dispensary) on ACC pathway (outpatient) or fluid chart (inpatient).

5.  Ampoules do not require reconstitution. Prepare on the ward/clinic.

6.  Dilute ferric carboxymaltose in a sodium chloride 0.9% bag according to the following table:

Iron Dose / Ferric Carboxymaltose (Ferinject) Volume / Sodium Chloride 0.9% Volume / Minimum Infusion Time
100mg to 200mg / 2mL to 4mL / 50mL / 3 minutes
201mg to 500mg / 4.1mL to 10mL / 100mL / 6 minutes
501mg to 1000mg / 10.1mL to 20mL / 250mL / 15 minutes

*For stability reasons ferric carboxymaltose must not be diluted to concentrations less than 2mg/mL

1.  Ensure cardiopulmonary resuscitation equipment is available
Life-threatening hypersensitivity reactions are a known risk with all IV iron preparations.

2.  Patient observations required before starting (as baseline) and at the end of infusion.

a.  Observations: Temperature, pulse, respiratory rate, blood pressure and oxygen saturation.

3.  The patient must remain under observation for 30 minutes after the end of the infusion.

Please share this information with relevant clinical staff.

For further information phone 6222 8462

Prepared by Rachael Wilson, Supervisory Pharmacist: Production

Authorised: Duncan McKenzie – Pharmacy Manager and Chair of Quality use of Medicines Committee

7th July 2014

Department of Health and Human Services