Ferinject Special Precautions

Hypersensitivity reactions: Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactoid reactions, which may be fatal (see Adverse Reactions). Therefore, facilities for cardiopulmonary resuscitation must be available. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Hypersensitivity reactions have also been reported after previously uneventful doses of any parenteral iron complexes, including ferric carboxymaltose. 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).
Hypophosphataemia/Hypophosphataemic osteomalacia: Parenterally iron preparations can lead to hypophosphataemia which is transient and without clinical symptoms in most cases. Hypophosphatemia 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 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.
No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200 mg iron are available.
Infection: Parenteral iron must be used with caution in case of acute or chronic infection, or in patients with a history of asthma, eczema, other atopic allergies or allergic reactions to other parenteral iron preparations, as they are particularly at risk of an allergic reaction. It is recommended that the administration of Ferinject is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis.
Extravasation: Caution should be exercised to avoid paravenous leakage when administering Ferinject. Paravenous leakage of Ferinject at the administration site may lead to potentially long lasting brown discolouration and irritation of the skin at the site of administration. In case of paravenous leakage, the administration of Ferinject must be stopped immediately.
Excipients: One ml of undiluted Ferinject contains up to 5.5 mg (0.24 mmol) of sodium. This has to be taken into account in patients on a sodium-controlled diet.
Do not administer 20 ml (1000 mg of iron) as an injection or infusion more than once a week.
Effects on ability to drive and use machines: Ferinject is unlikely to impair the ability to drive or operate machines.
Use in Children: The use of Ferinject has not been studied in children.