Avofer Special Precautions

Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which can be potentially fatal. Therefore, anti-allergic treatment should be available along with cardio-pulmonary resuscitation facilities and procedures. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. Each patient should be observed for adverse effects for at least 30 minutes following each Avofer injection. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see Adverse Reactions).
In patients with a history of asthma, eczema, other atopic allergies or allergic reactions to other parenteral iron preparations, Avofer should be administered with caution as these patients may be particularly at risk of an allergic reaction. However, in several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, iron sucrose was shown to be well tolerated.
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor. Careful monitoring of iron status is recommended to avoid iron overload.
Parenteral iron should be used with caution in the case of acute or chronic infection. It is recommended that the administration of Avofer is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.
Paravenous leakage must be avoided because leakage of Avofer at the injection site can lead to pain, inflammation, tissue necrosis and brown discoloration of the skin. If this occurs, the administration of Avofer must be stopped immediately. To date, tissue necrosis has not been found to occur in clinical studies using iron sucrose.
Effects on ability to drive and use machines: Avofer is unlikely to influence the ability to drive and use machines. However, if symptoms such as dizziness, confusion or light-headedness occur following the administration of Avofer, affected patients should not drive a car or use machines until the symptoms have abated.