Irsuc Special Precautions

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. 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 several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, IRSUC was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see Contraindications. The risk of hypersensitivity reactions is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy. There is also an increased risk of hypersensitivity conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis). Iron Injection should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each Iron injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardiorespiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. 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, in particular Porphyria Cutanea Tarda (PCT). 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 Iron Injection 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 Iron Injection at the injection site can lead to pain, inflammation and brown discoloration of the skin. Iron Injection contains up to 7 mg sodium per mL, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
General: 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 iron sucrose requires periodic monitoring of hematologic and hematinic parameters. Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus serum iron values may be reliably obtained 48 hrs after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving iron sucrose.
Hypotension: Hypotension has been reported in chronic kidney disease patients receiving intravenous iron. Hypotension following administration of iron sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer iron sucrose according to recommended guidelines.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of iron sucrose.
Use in Pregnancy and Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Safety and effectiveness of iron sucrose in pediatric patients have not been established.
Use in the Elderly: There are no identified differences in responses between elderly and younger patients, but greater sensitivity of some of the older individuals cannot be ruled out.