Ferric carboxymaltose

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.

The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of ferric carboxymaltose.

A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients.

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 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.

There are limited data from the use of ferric carboxymaltose in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and ferric carboxymaltose should not be used during pregnancy unless clearly necessary.

Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with ferric carboxymaltose should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.

Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.

Animal data suggest that iron released from ferric carboxymaltose can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus.

Clinical studies showed that transfer of iron from ferric carboxymaltose to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that ferric carboxymaltose represents a risk to the breast-fed child.

Fertility

There are no data on the effect of ferric carboxymaltose on human fertility. Fertility was unaffected following ferric carboxymaltose treatment in animal studies.

Ferric carboxymaltose is unlikely to impair the ability to drive and use machines.

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 subjects received ferric carboxymaltose, as well as those reported from the post-marketing experience (see table footnotes for details).

The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.

The most serious ADR is anaphylactoid/anaphylactic reactions (rare); fatalities have been reported.

Table 4. Adverse drug reactions observed during clinical trials and post-marketing experience:

¹ ADRs exclusively reported in the post-marketing setting; estimated as rare.
² ADRs reported in the post-marketing setting which are also observed in the clinical setting.
³ Includes the following preferred terms: rash (individual ADR determined to be uncommon) and rash erythematous, -generalised, -macular, -maculo-papular, -pruritic (all individual ADRs determined to be rare).
⁴ Includes, but is not limited to, the following preferred terms: injection/infusion site -pain, -haematoma, -discolouration, -extravasation, -irritation, -reaction, (all individual ADRs determined to be uncommon) and -paraesthesia (individual ADR determined to be rare).
Note: ADR = Adverse drug reaction.