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Tolerability

Ferinject has an established tolerability profile

  • Ferinject has more than 9.8 million patient-years of experience2

The most serious adverse reactions with IV iron are severe hypersensitivity reactions. These are rare, much more common with older, high molecular weight iron dextran preparations than with the more recent preparations.1 High molecular weight dextran is not available in the UK and Ireland.

  • Ferinject has a documented frequency of serious hypersensitivity reactions of fewer than 5 patients in 10,000 (0.045%)3

 

 

 

 

Ferinject tolerability profile

The table below presents the adverse drug reactions (ADRs) reported during clinical studies in which >8000 subjects received Ferinject, 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.

In clinical trials the minimum serum phosphorous values were obtained after approximately 2 weeks, and in most cases returned to baseline values by 12 weeks following Ferinject treatment .

The most serious ADR is anaphylactoid reactions (rare).4

Confidence from a breadth and depth of evidence5

proven efficacy
N = total study population (at baseline)
n = number of patients who received at least one dose of Ferinject

Adverse drug reactions observed during clinical trials and post-marketing experience4

 

Adverse drug reactions

 

1. ADRs exclusively reported in the post-marketing setting.

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.

 

Adverse events should be reported. Reporting forms and information can be found at:

UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland: www.hpra.ie/homepage/medicines/safety-information/reporting-suspected-side-effects

Adverse events should also be reported to Vifor Pharma UK Ltd.

Tel: +44 1276 853633

Email: Medicalinfo_uk@viforpharma.com

References

 
  1. Tomer A et al. Mayo Clin Proc 2015; 90(1): 12-23.
  2. Vifor Pharma Data on file 119.
  3. Vifor Pharma Data on file 40.
  4. Ferinject® Summary of Product Characteristics.
  5. Vifor Pharma Data on file 118.
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This website is intended for healthcare professionals who treat iron deficiency and iron deficiency anaemia in adults or patients who have been prescribed this medication.

UK-FCM-1900320, September 2019