This website is for Irish healthcare professionals. This website contains promotional material.

Reporting adverse events
A
A

Ferinject is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective; oral iron
preparations cannot be used; or there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency must
be based on laboratory tests.1

Back

How could Ferinject® (ferric carboxymaltose) help your patients
with non-dialysis chronic kidney disease?

Anaemia is a common complication in non-dialysis chronic
kidney disease (ND-CKD)2

  • Anaemia affects 3 out of 4 patients with ND-CKD and GFR <152
  • Prevalence of anaemia increases with progression of ND-CKD2
  • Anaemia has a physical and emotional impact on patients with ND-CKD3-5
  • Studies suggest that 60-70% of non-dialysis patients with CKD (stage 3-5) may be iron deficient6

Iron is a cornerstone of treatment for iron deficiency anaemia in patients with
ND-CKD

In anaemia of CKD, iron sequestration, plus the rapid demands of the bone marrow, means that additional
iron therapy is often needed to support the use of ESAs:7

Functional iron deficiency or iron restricted erythropoiesis

+/- ESA

Efficient production of red blood cells

Sustainable correction of anaemia in ND-CKD

Sustainable correction of iron deficiency anaemia with Ferinject:
results from the FIND-CKD study8

In the 56-week, open label, randomised FIND-CKD study that compared efficacy and safety of IV Ferinject, targeted to different
ferritin levels, with daily oral ferrous sulphate therapy:

  • Targeting higher ferritin levels with Ferinject allowed a quick and sustainable correction of iron deficiency anaemia compared with targeting 
    low-ferritin with Ferinject or oral ferrous sulphate8

Study design

Effect of Ferinject versus ferrous sulphate on ferritin8

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Serum ferritin was maintained within the target range over 52 weeks with an overall average dose of 2.7 g of Ferinject
    (500-1000 mg of iron per administration)
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Effect of Ferinject versus ferrous sulphate on TSAT8

inline_image

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Improved TSAT levels within the first
    4 weeks with 1 g Ferinject compared
    with targeting low-ferritin with
    Ferinject or oral ferrous sulphate
  • Maintained TSAT levels over 1 year
    with an average of four injections over
    52 weeks and an amount of
    500-1,000 mg of iron per injection
    (overall average dose 2.7 g)
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Effect of Ferinject versus ferrous sulphate on Hb8

inline_image

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Targeting high-ferritin with Ferinject
    resulted in higher mean Hb after
    4 weeks compared with targeting low-
    ferritin with Ferinject or oral ferrous
    sulphate
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Effect of Ferinject versus ferrous sulphate on ferritin8

Effect of Ferinject versus ferrous sulphate on ferritin8

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Serum ferritin was maintained within the target range over 52 weeks with an overall average dose of 2.7 g of Ferinject
    (500-1000 mg of iron per administration)
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Effect of Ferinject versus ferrous sulphate on TSAT8

Effect of Ferinject versus ferrous sulphate on TSAT8

inline_image

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Improved TSAT levels within the first
    4 weeks with 1 g Ferinject compared
    with targeting low-ferritin with
    Ferinject or oral ferrous sulphate
  • Maintained TSAT levels over 1 year
    with an average of four injections over
    52 weeks and an amount of
    500-1,000 mg of iron per injection
    (overall average dose 2.7 g)
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Effect of Ferinject versus ferrous sulphate on Hb8

Effect of Ferinject versus ferrous sulphate on Hb8

inline_image

Targeting 400-600 mcg/L serum ferritin with Ferinject:8

  • Targeting high-ferritin with Ferinject
    resulted in higher mean Hb after
    4 weeks compared with targeting low-
    ferritin with Ferinject or oral ferrous
    sulphate
Oral ferrous sulphate was withheld if serum ferritin > 200 mcg/L and restarted if/when serum ferritin < 100 mcg/L
Adapted from Macdougall I C et al, 2014.8

Ferinject has a well-characterised tolerability profile:1

  • The most commonly reported adverse drug reaction (ADR) is nausea (3.2%), 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 anaphylactic reactions (rare); fatalities have been reported. Ferinject has a documented frequency of serious hypersensitivity reactions of less than 1 in 1,000. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction)
  • Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Ferinject administration
  • If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic reactions should be available, including an injectable 1:1,000 adrenaline solution
  • Hypophosphataemia is a common (≥1/100 to <1/10) adverse drug reaction. Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain. Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated

 

Please refer to the Ferinject Summary of Product Characteristics for complete tolerability information

Find out more

ADR, adverse drug reaction; CKD, chronic kidney disease; CI, confidence interval; ERBP, European Renal Best Practice; ESA, erythropoiesis stimulating agent; Hb, haemoglobin; HR, hazard ratio; GFR, glomerular filtration rate; ID, Iron deficiency; IV, intravenous; KDIGO, Kidney Disease Improving Global Outcomes; ND-CKD, non-dialysis chronic kidney disease; NICE, National Institute for Health and Care Excellence; TSAT, transferrin saturation.

References

1. Ferinject Summary of Product Characteristics. 2. McClellan W, et al. Curr Med Res Opin 2004;20(9):1501–10. 3. Mehdi U, et al. Diabetes Care 2009;32(7):1320–26. 4. Agarwal R. Am J Nephrol 2007;27(6):565–71. 5. Eriksson D, et al. BMC Nephrol 2016;17(1):97. 6. Fishbane S et al. Clin J Am Soc Nephrol. 2009;4:57–61. 7. Macdougall IC. Curr Med Res Opin 2010;26(2):473–82. 8. Macdougall IC, et al. Nephrol Dial Transplant 2014;29(11):2075-84.

More about Ferinject

Ferinject in patients with heart failure

Find out more

Oral or IV iron

Find out more