Venofer 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. In case of hypersensitivity reactions, healthcare professionals should immediately stop the iron administration and consider appropriate treatment for the hypersensitivity reaction. 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. However, in several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer 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 Venofer 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 Venofer at the injection site can lead to pain, inflammation, tissue necro­sis and brown discoloration of the skin. If this occurs, the administration of Venofer must be stopped immediately. To date, tissue necrosis has not been found to occur in clinical studies using Venofer.
Effects on ability to drive and use machines: Venofer 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 Venofer, affected patients should not drive a car or use machines until the symptoms have abated.