Safety
Ferinject® (ferric carboxymaltose) has a well-characterised safety profile based on clinical trial and post-marketing data in over 9,000 patients, including adults and paediatric patients aged 1–17 years, across multiple therapeutic areas requiring intravenous iron therapy.1–7
Most common adverse drug reactions (ADRs)
The most commonly reported adverse drug reaction with Ferinject® is nausea (3.2%). Other commonly reported ADRs include injection/infusion-site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension.7
Hypersensitivity reactions
Parenterally administered iron preparations, including ferric carboxymaltose, can cause hypersensitivity reactions, including rare anaphylactic reactions, which may be fatal.7
There have been reports of hypersensitivity reactions progressing to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction).7
Facilities for cardiopulmonary resuscitation must be available, and treatment must be stopped immediately if hypersensitivity reactions or signs of intolerance occur.7
Hypophosphataemia
Parenterally administered iron preparations can cause hypophosphataemia.7
Cases requiring medical intervention have been reported, particularly:
- In patients with existing risk factors.
- After prolonged exposure to high-dose intravenous iron.7
Post-marketing reports include cases of hypophosphataemic osteomalacia and fractures, some requiring surgical intervention.7
Patients should be advised to seek medical attention if they experience bone pain or arthralgia.7
Patients receiving multiple high doses long-term and with underlying risk factors (e.g. vitamin D deficiency, calcium/phosphate malabsorption, secondary hyperparathyroidism, inflammatory bowel disease, osteoporosis) should be monitored. In cases of persistent hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated.7
Safety in heart failure clinical trials
Across multiple randomised controlled trials in patients with heart failure and iron deficiency, the incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation was similar between ferric carboxymaltose and comparator groups.2–6
No excess in all-cause mortality or serious safety signals were observed in these studies.2–6
Paediatric population
The safety profile of Ferinject® in children and adolescents aged 1–17 years is comparable with that observed in adults.1
Please always consult the SmPC for the full list of special warnings and precautions, contraindications and adverse reactions before prescribing.
All health care professionals must report adverse events and special situations associated with CSL products, within 24 hours of receipt of the information when they become aware or are informed about it, to Global Drug Safety at safety@viforpharma.com
Information to report shall include the company product, the identifiable reporter, the adverse event or special information, and the identifiable patient.
References & footnotes
Abbreviations
AE, adverse event; ADR, adverse drug reaction; HF, heart failure; RCT, randomised controlled trial; SmPC, Summary of product Characteristics.
References
- Ferinject UAE SmPC. Ferinject KSA SmPC.
- Ponikowski P et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet 2020;396(10266):1895–904.
- Ponikowski P et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J 2015;36(11):657–68.
- Anker SD et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009;361(25):2436–48.
- van Veldhuisen DJ et al. Effect of ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency. Circulation 2017;136(15):1374–83.
- Mentz RJ et al. Ferric carboxymaltose in heart failure with iron deficiency. N Engl J Med 2023;389(11):975–86.
- Ferinject Approved Product Information.
- McDonagh TA et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2021;42(36):3599–726.
- McDonagh TA et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2023;44(37):3627–39.