MALTOFER

What it is

MALTOFER contains a macromolecular spherocolloidal complex of iron (III) hydroxide and the carbohydrate polymaltose. MALTOFER is available as tablets, syrup, and drops, with each formulation containing iron polymaltose equivalent to elemental iron.

Approved indications

MALTOFER is indicated for the treatment of iron deficiency anaemia when oral therapy is contraindicated, when enteric absorption of iron is defective, or when patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical. — Iron deficiency anaemia in patients for whom oral therapy is contraindicated, absorption is defective, or oral therapy is impractical due to non-compliance or gastrointestinal intolerance.

Dosing overview

For patients up to 34 kg body weight, the target haemoglobin is 130 g/L with an iron depot of 15 mg per kilogram of body weight. For patients over 34 kg body weight, the target haemoglobin is 150 g/L with an iron depot of 500 mg. The required dose is calculated using the Ganzoni formula: iron dose equals body weight (kg) multiplied by (target haemoglobin minus actual haemoglobin in g/L) multiplied by 0.24, plus iron depot (mg).

Key safety warnings

Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactoid reactions, which may be potentially fatal, and there have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Facilities for cardio-pulmonary resuscitation must be available. Patients should be monitored during and after MALTOFER administration for at least 30 minutes. Patients with bronchial asthma, low iron binding capacity or folic acid deficiency are particularly at risk of an allergic or anaphylactoid reaction. Patients with rheumatoid arthritis and possibly other inflammatory diseases (such as ankylosing spondylitis or lupus erythematosus) may be at particular risk of delayed reactions, including fever and exacerbation or reactivation of joint pain. MALTOFER should only be used in pregnancy if the benefits outweigh the risk due to the risk of anaphylaxis, and should not be administered in the first trimester of pregnancy.

Contraindications

MALTOFER should not be given to patients with hypersensitivity to iron (III) hydroxide polymaltose complex. MALTOFER is contraindicated in anaemia not caused by simple iron deficiency, such as haemolytic anaemia, megaloblastic anaemia caused by vitamin B12 deficiency, disturbances in erythropoiesis, or hypoplasia of the marrow. MALTOFER is contraindicated in iron overload (such as haemochromatosis or haemosiderosis), chronic polyarthritis, bronchial asthma, infectious renal complaints in acute phase, uncontrolled hyperparathyroidism, decompensated hepatic cirrhosis, infectious hepatitis, and during the first trimester of pregnancy.

Regulatory history

MALTOFER received TGA approval on 8 April 2002. MALTOFER Tablets were first listed on the ARTG on 22 October 2014, MALTOFER Syrup on 14 November 2014, and MALTOFER Drops on 14 November 2014.