FERRIVE

What it is

FERRIVE is ferric carboxymaltose, available in vials containing 100 mg, 500 mg, or 1000 mg iron. It is a dark brown, opaque, aqueous solution for injection.

Approved indications

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

Dosing overview

In adults and adolescents aged 14 years and older, dosing follows a stepwise approach: determination of the cumulative iron dose, calculation and administration of the maximum individual iron dose(s), and post-iron repletion assessments. The cumulative iron dose is determined using either the Ganzoni method or simplified method based on body weight and haemoglobin level. A single administration should not exceed 20 mg iron per kilogram body weight or 1000 mg of iron, with a maximum recommended cumulative dose of 1000 mg per week. Haemoglobin level should be reassessed no earlier than 4 weeks after final administration. In children aged 1 to 13 years, FERRIVE should be administered in 2 intravenous doses of 15 mg iron per kilogram body weight with an interval of at least 7 days, with a maximum single iron dose of 750 mg and maximum cumulative dose of 1500 mg. In adult haemodialysis-dependent chronic kidney disease patients, a single maximum daily dose of 200 mg iron should not be exceeded.

Key safety warnings

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

Contraindications

FERRIVE is contraindicated in cases of hypersensitivity to ferric carboxymaltose complex, FERRIVE or 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.

Regulatory history

FERRIVE was first listed on the Australian Register of Therapeutic Goods on 12 November 2025, with three registered variants containing 100 mg, 500 mg, and 1000 mg iron per vial.