FERIVO

What it is

FERIVO contains ferric carboxymaltose and is available in vials of 100 mg, 500 mg, or 1000 mg iron. It is a solution for intravenous use. FERIVO is a dark brown, non-transparent, colloidal solution.

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

Adults and adolescents aged 14 years and older receive dosing based on body weight and haemoglobin level, using either the Ganzoni Method or a Simplified Method. A single administration should not exceed 20 mg iron per kilogram body weight or 1000 mg of iron, and the maximum recommended cumulative dose is 1000 mg per week. If additional dosing is required, doses must be given a minimum of 7 days apart. Children aged 1 to 13 years receive 15 mg iron per kilogram body weight in two intravenous doses with an interval of at least 7 days, with a maximum single dose of 750 mg iron and maximum cumulative dose of 1500 mg iron.

Key safety warnings

Body iron excretion is limited and excess tissue iron can cause haemosiderosis. Patients receiving FERIVO require regular monitoring of red cell indices and serum ferritin to detect iron overload. 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, an acute allergic coronary arteriospasm that can result in myocardial infarction. Facilities for cardio-pulmonary resuscitation must be available. Each patient should be observed for adverse effects for at least 30 minutes following each FERIVO 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 hypophosphataemic osteomalacia and fractures requiring clinical intervention including surgery were reported in the post-marketing setting. Caution should be exercised to avoid paravenous leakage when administering FERIVO, as it may lead to potentially long-lasting brown discolouration and irritation of the skin.

Contraindications

FERIVO is contraindicated in cases of hypersensitivity to ferric carboxymaltose complex, FERIVO, 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

FERIVO iron (as ferric carboxymaltose) in three strengths—100 mg/2 mL, 500 mg/10 mL, and 1000 mg/20 mL injection vials—were first listed on the Australian Register of Therapeutic Goods on 23 January 2026.