VENOFER

What it is

VENOFER contains 20 mg/mL iron as iron sucrose (iron(III) hydroxide sucrose complex), with 100 mg iron per 5 mL ampoule. It is a concentrated injection for intravenous use. VENOFER is a dark brown, non-transparent, aqueous solution with a pH of 10.5–11.0 and an osmolarity of 1250 mOsmol/L.

Approved indications

— Iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy.

Dosing overview

The recommended dosage of VENOFER for the treatment of iron deficiency in hemodialysis patients receiving erythropoietin therapy is 100 mg of iron (5 mL) delivered intravenously during the dialysis session, with dosing frequency not more than three times per week. Most patients will require a minimum cumulative dose of 1000 mg of iron, administered over 10 sequential dialysis sessions, to achieve a favourable haemoglobin or haematocrit response. Patients may continue to require therapy with VENOFER at the lowest dose necessary to maintain target levels of haemoglobin, haematocrit and laboratory parameters of iron storage within acceptable limits.

Key safety warnings

Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which can be potentially fatal. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). Anti-allergic treatment should be available along with cardio-pulmonary resuscitation facilities and procedures. Each patient should be observed for adverse effects for at least 30 minutes following each VENOFER injection. In patients with a history of asthma, eczema, other atopic allergies or allergic reactions to other parenteral iron preparations, VENOFER should be administered with caution as these patients may be particularly at risk of an allergic reaction. Hypotension has been reported frequently in hemodialysis patients receiving intravenous iron. Hypotension following administration of VENOFER may be related to rate of administration and total dose administered. Paravenous leakage must be avoided because leakage of VENOFER at the injection site may lead to pain, inflammation, sterile abscess and brown discolouration of the skin. Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised to withhold iron administration in the presence of evidence of tissue iron overload. Patients receiving VENOFER require periodic monitoring of hematologic and hematinic parameters (haemoglobin, haematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of iron overload.

Contraindications

VENOFER is contraindicated in hypersensitivity to iron sucrose, VENOFER or to any of its excipients; anaemia not caused by iron deficiency; iron overload or disturbances in utilisation of iron; known haemochromatosis or genetic tendency to haemochromatosis; and pregnancy in the first trimester.

PBS listing

VENOFER is listed on the PBS as a concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL under 2 PBS items with unrestricted, streamlined restriction status, at an ex-manufacturer price of A$24.25.

Regulatory history

VENOFER was first approved on 19 May 2004 (ARTG 98236).