Ferinject Special Precautions

Hypersensitivity reactions: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes. 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).
The risk 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 reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Ferric carboxymaltose (Ferinject) should only be administered when staff trained to evaluate and manage anaphylactic reactions are 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 Ferric carboxymaltose (Ferinject) administration. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
Hypophosphataemia/Hypophosphataemic osteomalacia: Parenterally iron preparations can lead to hypophosphataemia which is transient and without clinical symptoms. Hypophosphataemia requiring treatment has mainly been reported in individual cases, in patients with known risk factors and after sustained higher dosing.
Cases of symptomatic hypophosphataemia leading to hypophosphataemic osteomalacia, and fractures requiring clinical intervention, including surgery, were reported after market introduction. In case of arthralgia or bone pain, patients should be advised to seek medical advice.
Patients receiving multiple higher doses as part of long-term treatment, and who have underlying risk factors (e.g. vitamin D deficiency, calcium and phosphate malabsorption, secondary hyperparathyroidism, hereditary haemorrhagic telangiectasia, inflammatory bowel disease and osteoporosis) should be monitored for hypophosphataemic osteomalacia, including serum phosphate control. In case of persistent hypophosphataemia, treatment with Ferinject should be re-evaluated.
Hepatic or renal impairment: In patients with liver dysfunction, parenteral iron should only be administered after careful benefit/risk 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.
No safety data on haemodialysis-dependent chronic kidney disease patients receiving single dose of more than 200 mg iron are available.
Infection: Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that the treatment with Ferric carboxymaltose (Ferinject) is stopped in patients with ongoing bacteraemia. Therefore, in patients with chronic infection a benefit/risk evaluation has to be performed, taking into account the suppression of erythropoiesis.
Extravasation: Caution should be exercised to avoid paravenous leakage when administering Ferric carboxymaltose (Ferinject). Paravenous leakage of Ferric carboxymaltose (Ferinject) at the administration site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of administration. In case of paravenous leakage, the administration of Ferric carboxymaltose (Ferinject) must be stopped immediately.
Excipients: Ferric carboxymaltose (Ferinject) contains up to 5.5 mg (0.24 mmol) sodium per mL of undiluted solution, equivalent to 0.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Effects on ability to drive and use machines: Ferric carboxymaltose (Ferinject) is unlikely to impair the ability to drive and use machines.