Learn more about how oral iron and intravenous (IV) iron compare when
treating patients for iron deficiency
 |
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 |
Oral or IV iron
The use of IV Ferinject® (ferric carboxymaltose) compared to oral ferrous
sulphate for the treatment of iron deficiency anaemia after acute GI
bleeding: results from a clinical study2*
The efficacy and safety of Ferinject and ferrous sulphate (FeSulf) were compared in a prospective, randomised study in 61 patients with iron deficiency anaemia secondary to non-variceal gastrointestinal bleeding.2
Complete and partial response rates after Ferinject or FeSulf administration2
In the Ferinject arm versus the FeSulf arm:2
- A higher proportion of complete response was observed at Days 21 (85.7% vs 45.2%, p=0.001) and 42
(100% vs 61.3%; p<0.001) - The percentage of patients with partial response was significantly higher (Day 21:100% vs 67.7%; p=0.001,
Day 42:100% vs 74.2%; p=0.003) - At Day 42, normalisation of TSAT to 25% or greater was observed in 76.9% vs 24.1% of patients (p<0.001)
Complete response (primary outcome)Hb levels ≥12 g/dL or ≥13 g/dL in women and men, respectively,
|
Partial response (secondary outcome)Hb increase ≥2 g/dL versus baseline at Day 7, 21 or 422
|
Mean Hb levels (secondary outcome)
|
Mean TSAT index (secondary outcome)
|
Adapted from Ferrer-Barcelo L et al, 2019.2
*Patients with Hb<10 g/dL upon discharge (Day 0) received Ferinject (n=29; Day 0: 1,000 mg, Day 7: 500 or 1,000 mg; per label) or FeSulf (n=32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42.
How do IV iron and oral iron compare for the treatment of iron deficiency
anaemia in patients with GI bleeding?
IV iron is indicated when oral iron is ineffective or cannot be used, or when there is the clinical need to deliver iron rapidly.
Advantages of IV iron
|
Disadvantages of IV iron
|
Tolerability
IV iron is associated with less GI side effects compared to some forms of oral iron.5 Discontinuation of treatment due to adverse events or intolerance is lower with IV iron as compared to some forms of oral iron.5
| IV (%) | Oral (%) | |
| Occurrence of GI side effects5 | ||
| Nausea | 1.6 | 4.9 |
| Vomiting | 1.0 | 6.8 |
| Abdominal pain | 1.3 | 7.9 |
| Diarrhoea | 0.9 | 8.3 |
| AE-related discontinuation rates | 2.5 | 10.9 |
| Serious adverse events* | 4.2 | 0.4 |
Adapted from Bonovas S et al, 2016.5
This review included studies conducted with oral ferrous fumarate, oral ferrous sulphate, IV iron sucrose, IV ferric carboxymaltose and IV iron isomaltoside (now ferric derisomaltose).
*A causal relationship between IV iron and the serious adverse events reported could not be inferred in this study.
When should patients who are non-responsive to oral iron switch
to IV iron therapy?
FIND-CKD was a 56-week, open-label, multicentre, prospective, randomised study comparing IV Ferinject with oral ferrous sulphate in 626 patients with CKD and iron deficiency anaemia.6
A post-hoc analysis sought to analyse erythropoietic response to oral ferrous sulphate therapy over time:7
- Response was defined as an increase in haemoglobin (Hb) of ≥1g/dL vs baseline
- Patients were categorised as ‘responders’ or ‘non-responders’ based on haemoglobin response at week 4
- There were 78.4% non-responders in the oral ferrous sulphate group at week 4 compared to 86.1% and 59.1% non-
responders in the low ferritin and high ferritin target group, respectively
Cumulative response rates (%) of Week 4 non-responders over time
Adapted from Macdougall I C et al, 2017.7 |
By week 52, more than 50% of patients did not respond to oral ferrous sulphate
treatment suggesting that IV Ferinject, aimed at targeting high-ferritin levels,
might be beneficial for patients who do not respond to oral treatment by week 47
In the FIND-CKD study, more patients discontinued ferrous sulphate therapy due to adverse events compared with Ferinject.8
|
Study drug discontinuation8
|
Oral or IV iron in patients with
Gastrointestinal (GI) bleeding
The use of IV Ferinject® (ferric carboxymaltose) compared to oral ferrous
sulphate for the treatment of iron deficiency anaemia after acute GI
bleeding: results from a clinical study2*
The efficacy and safety of Ferinject and ferrous sulphate (FeSulf) were compared in a prospective, randomised study in 61 patients with iron deficiency anaemia secondary to non-variceal gastrointestinal bleeding.2
Complete and partial response rates after Ferinject or FeSulf administration2
In the Ferinject arm versus the FeSulf arm:2
- A higher proportion of complete response was observed at Days 21 (85.7% vs 45.2%, p=0.001) and 42
(100% vs 61.3%; p<0.001) - The percentage of patients with partial response was significantly higher (Day 21:100% vs 67.7%; p=0.001,
Day 42:100% vs 74.2%; p=0.003) - At Day 42, normalisation of TSAT to 25% or greater was observed in 76.9% vs 24.1% of patients (p<0.001)
Complete response (primary outcome)Hb levels ≥12 g/dL or ≥13 g/dL in women and men, respectively,
|
Partial response (secondary outcome)Hb increase ≥2 g/dL versus baseline at Day 7, 21 or 422
|
Mean Hb levels (secondary outcome)
|
Mean TSAT index (secondary outcome)
|
Adapted from Ferrer-Barcelo L et al, 2019.2
*Patients with Hb<10 g/dL upon discharge (Day 0) received Ferinject (n=29; Day 0: 1,000 mg, Day 7: 500 or 1,000 mg; per label) or FeSulf (n=32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42.
How do IV iron and oral iron compare for the treatment of iron deficiency
anaemia in patients with GI bleeding?
IV iron is indicated when oral iron is ineffective or cannot be used, or when there is the clinical need to deliver iron rapidly.
Advantages of IV iron
|
Disadvantages of IV iron
|
Tolerability
IV iron is associated with less GI side effects compared to some forms of oral iron.5 Discontinuation of treatment due to adverse events or intolerance is lower with IV iron as compared to some forms of oral iron.5
| IV (%) | Oral (%) | |
| Occurrence of GI side effects5 | ||
| Nausea | 1.6 | 4.9 |
| Vomiting | 1.0 | 6.8 |
| Abdominal pain | 1.3 | 7.9 |
| Diarrhoea | 0.9 | 8.3 |
| AE-related discontinuation rates | 2.5 | 10.9 |
| Serious adverse events* | 4.2 | 0.4 |
Adapted from Bonovas S et al, 2016.5
This review included studies conducted with oral ferrous fumarate, oral ferrous sulphate, IV iron sucrose, IV ferric carboxymaltose and IV iron isomaltoside (now ferric derisomaltose).
*A causal relationship between IV iron and the serious adverse events reported could not be inferred in this study.
Oral or IV iron in patients
with chronic kidney disease CKD
When should patients who are non-responsive to oral iron switch
to IV iron therapy?
FIND-CKD was a 56-week, open-label, multicentre, prospective, randomised study comparing IV Ferinject with oral ferrous sulphate in 626 patients with CKD and iron deficiency anaemia.6
A post-hoc analysis sought to analyse erythropoietic response to oral ferrous sulphate therapy over time:7
- Response was defined as an increase in haemoglobin (Hb) of ≥1g/dL vs baseline
- Patients were categorised as ‘responders’ or ‘non-responders’ based on haemoglobin response at week 4
- There were 78.4% non-responders in the oral ferrous sulphate group at week 4 compared to 86.1% and 59.1% non-
responders in the low ferritin and high ferritin target group, respectively
Cumulative response rates (%) of Week 4 non-responders over time
Adapted from Macdougall I C et al, 2017.7 |
By week 52, more than 50% of patients did not respond to oral ferrous sulphate
treatment suggesting that IV Ferinject, aimed at targeting high-ferritin levels,
might be beneficial for patients who do not respond to oral treatment by week 47
In the FIND-CKD study, more patients discontinued ferrous sulphate therapy due to adverse events compared with Ferinject.8
|
Study drug discontinuation8
|
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 moreFIND-CKD study design:6
Adapted from Macdougall I C et al, 2014.6
*Patients ≤66 kg: 500 mg iron on days 0 and 7.6
†Patients ≤66 kg: 500 mg iron on day of visit and 500 mg iron one week later.6
‡No administration if transferrin saturation level ≥40%.6
§Ferrous sulphate was withheld if serum ferritin >200 mcg/L and restarted if/when serum ferritin <100 mcg/L.
The last dose of Ferinject was administered at week 48, and the last dose of ferrous sulphate was administered at week 52.6
CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESA, erythropoiesis stimulating agent; Hb, haemoglobin; IV, intravenous; MDRD, Modification of Diet in Renal Disease.
6. Macdougall IC et al. Nephrol Dial Transplant 2014;29:2075–2084.
ADR, adverse drug reaction; AE, adverse event; CKD, chronic kidney disease; ESC, European Society of Cardiology; FeSulf, ferrous sulphate; Hb, haemoglobin; GI, gastrointestinal; IV, intravenous; ND-CKD, non-dialysis chronic kidney disease; TSAT, transferrin saturation.
1. Ferinject Summary of Product Characteristics. 2. Ferrer-Barcelo L, et al. Aliment Pharmacol Ther 2019;50(3):258–68. 3. Prodiggest 2017 Healthcare protocols to improve interdisciplinary management of gastrointestinal diseases in hospital settings. Available at: aegastro.es. Accessed April 2022. 4. Bayraktar UD, et al. World J Gastroenterol 2010;16(22):2720–2725. 5. Bonovas S, et al. Medicine 2016;95(2):e2308. 6. Macdougall IC, et al. Nephrol Dial Transplant 2014;29(11):2075–84. 7. Macdougall IC, et al. Clin Nephrol 2017;88(12):301–10. 8. Roger SD, et al. Nephrol Dial Transplant 2017;32(9):1530–1539. 9. Macdougall IC, et al. Am J Nephrol 2018;48(4):260–68.
Ferinject IN patients with NON-DIALYSIS
CHRONIC KIDNEY DISEASE
2023 FOCUSED UPDATE OF ESC 2021
HF GUIDELINES
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