Published: 6 March 2014
Revised: 4 April 2014

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Intravenous Iron and Hypersensitivity

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Prescriber Update 35(1): 3–4
March 2014

The European Medicines Agency (EMA) has recently issued new recommendations to manage the risk of allergic reactions with intravenous iron. A test dose of intravenous iron is no longer recommended.

Patients are at risk of hypersensitivity or allergic reactions with every dose of intravenous iron. Allergic reactions can still occur even if patients have tolerated previous doses or have not reacted to a test dose.

The risk of hypersensitivity is increased in patients with known allergies, inflammatory conditions or a history of asthma, eczema or other atopy.

Intravenous iron should not be used in pregnancy unless clearly necessary and only if the benefits outweigh the potential risks to the mother and foetus. As currently stated in the New Zealand data sheets, use of these products in the first trimester of pregnancy is contraindicated^1-3.

Intravenous iron should only be administered when resuscitation facilities are immediately available and with trained staff present. Each patient should be monitored for signs and symptoms of hypersensitivity during and after each administration for at least 30 to 60 minutes.

New Zealand has three approved intravenous iron medicines: Ferrosig and Ferrum H (both iron polymaltose), and Venofer (iron sucrose)^1-3 (see Update).

The Centre for Adverse Reactions Monitoring (CARM) has received a total of 103 reports of hypersensitivity for iron polymaltose and iron sucrose. Of these reports, 81 were for women and 25 were for pregnant women. All patients recovered and most of the reports were classified as not serious.

Medsafe is currently working with the relevant sponsors to ensure all data sheets for intravenous iron medicines contain these new recommendations.

Update

Ferinject (Ferric carboxymaltose) is also an intravenous iron medicine approved in New Zealand. The data sheet is available on the Medsafe website.

References

1. Pharmacy Retailing (NZ) Ltd. 2009. Ferrosig Data Sheet 6 November 2009. URL: www.medsafe.govt.nz/profs/Datasheet/f/Ferrosiginj.pdf (accessed 12 February 2014).
2. Pharmacy Retailing (NZ) Ltd. 2012. Ferrum H Data Sheet July 2012. URL: www.medsafe.govt.nz/profs/Datasheet/f/FerrumHinj.pdf (accessed 12 February 2014).
3. Pharmacy Retailing (NZ) Ltd. 2007. Venofer Data Sheet 18 May 2007. URL: www.medsafe.govt.nz/profs/Datasheet/v/venoferinf.pdf (accessed 12 February 2014).