FERINJECT

What it is

Ferinject is a solution for intravenous injection containing ferric carboxymaltose, available in three strengths: 100 mg iron in a 2 mL vial, 500 mg iron in a 10 mL vial, and 1000 mg iron in a 20 mL vial. Ferinject is a dark brown, non-transparent, colloidal solution.

Approved indications —

Iron deficiency in adults and adolescents aged 14 years and older when oral iron preparations are ineffective, oral iron preparations cannot be used, or there is a clinical need to deliver iron rapidly. — Iron deficiency anaemia in children aged 1 to 13 years when oral iron preparations are ineffective or oral iron preparations cannot be used.

Dosing overview

In adults and adolescents aged 14 years and older, the dosing regimen follows a stepwise approach: determination of the cumulative iron dose, calculation and administration of the maximum individual iron doses, and post-iron repletion assessments. The cumulative dose for repletion is determined based on the patient's body weight and haemoglobin level. Two methods are available for determining the cumulative dose: the Ganzoni Method and the Simplified Method. A single administration should not exceed 20 mg iron per kilogram body weight or 1000 mg of iron. The maximum recommended cumulative dose is 1000 mg of iron per week. If the total iron need is higher, an additional dose should be administered a minimum of 7 days apart from the first dose. In children aged 1 to 13 years, Ferinject should be administered in two intravenous doses of 15 mg iron per kilogram body weight, with an interval of at least 7 days. The maximum single dose may not exceed 750 mg iron, and the maximum cumulative dose must not exceed 1500 mg iron.

Key safety warnings

Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactic reactions, which may be fatal. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Facilities for cardiopulmonary resuscitation must be available. Each patient should be observed for adverse effects for at least 30 minutes following each Ferinject administration. Parenterally administered iron preparations can cause hypophosphataemia which in most cases is transient and without clinical symptoms. Cases of hypophosphataemia requiring medical attention were reported, mainly in patients with existing risk factors and after prolonged exposure to high-dose intravenous iron. Cases of hypophosphataemia leading to hypophosphataemic osteomalacia and fractures which required clinical intervention including surgery were reported in the post-marketing setting. Body iron excretion is limited and excess tissue iron can be hazardous causing haemosiderosis. Patients receiving Ferinject require regular monitoring of red cell indices and serum ferritin to detect iron overload. If there is evidence of iron overload, iron therapy should be withheld. Caution should be exercised to avoid paravenous leakage when administering Ferinject. Paravenous leakage of Ferinject at the administration site may lead to potentially long-lasting brown discolouration and irritation of the skin.

Contraindications

Ferinject is contraindicated in cases of hypersensitivity to ferric carboxymaltose complex, to Ferinject or to any of its excipients; anaemia not attributed to iron deficiency (such as other microcytic anaemia); and evidence of iron overload or disturbances in utilisation of iron.

PBS listing

Ferinject is listed on the PBS with two strengths: injection 500 mg iron in 10 mL with an ex-manufacturer price of A$54.63, and injection 1000 mg iron in 20 mL with an ex-manufacturer price of A$109.25. Both items are unrestricted.

Regulatory history

Ferinject was first registered on the ARTG on 21 April 2011 with two strengths: 100 mg iron in 2 mL and 500 mg iron in 10 mL. A third strength of 1000 mg iron in 20 mL was added to the ARTG on 5 June 2018. In November 2018, the PBAC recommended listing of the new 1000 mg strength for iron deficiency anaemia as an unrestricted benefit.