Intravenous iron (ferric carboxymaltose, ferric derisomaltose)
AMT in HFrEF · Class I (symptoms/QoL, B1); IIa (reduce HFH, B1)Removal by dialysis
What each drug's prescribing information says about removal by (haemo)dialysis. Where the label is silent, this page says so rather than inferring from protein binding.
- Ferric carboxymaltoseLabel does not address dialysis removal
The label contains no statement on dialysis removal (indications include non-dialysis-dependent CKD).
- Ferric derisomaltoseLabel does not address dialysis removal
The label contains no statement on dialysis removal (indications include non-dialysis-dependent CKD).
Drugs and doses
| Drug | Brands | Start | Target | Kidney dosing |
|---|---|---|---|---|
| Ferric carboxymaltose | Injectafer, Ferinject | HF dosing by weight and Hb (label Table 1): e.g. 1,000 mg day 1; week 6 500-1,000 mg or none | Maintenance 500 mg at 12, 24 and 36 weeks if still iron deficient | No renal dose adjustment; renal elimination of iron negligible. Labelled for IDA in non-dialysis CKD; not labelled for dialysis-dependent CKD. Boxed warning (08/2026) for symptomatic hypophosphataemia: check phosphate before a repeat course. |
| Ferric derisomaltose | Monoferric, Monofer | 1,000 mg i.v. single infusion (>=50 kg); 20 mg/kg if <50 kg | Repeat per iron indices (IRONMAN: re-dose every 4 months if ferritin <100 or TSAT <25% unless ferritin >400) | No renal dose adjustment. Labelled for IDA incl. non-hemodialysis-dependent CKD; not labelled for hemodialysis-dependent CKD. No HF indication in the US label. |
Status by kidney stage
| Stage | Initiate | Continue |
|---|---|---|
| G1 | Recommended ESC 2026 Class I (symptoms/QoL) and IIa (HFH) in symptomatic HFrEF with iron deficiency; FCM has an FDA HF indication. | Recommended Re-dose when iron deficiency recurs (label maintenance schedule). |
| G2 | Recommended As G1; benefit similar across kidney function. | Recommended Re-dose when iron deficiency recurs. |
| G3a | Recommended ESC CVD-CKD 2026 IIa for HFrEF + CKD + ID to reduce HFH; FCM labelled for IDA in non-dialysis CKD. | Recommended Re-dose when iron deficiency recurs. |
| G3b | Recommended IRONMAN: patients with eGFR <45 had worse outcomes and possibly greater benefit; ESC CVD-CKD IIa. | Recommended Re-dose when iron deficiency recurs. |
| G4 | Recommended IRONMAN enrolled down to eGFR 15; ESC CVD-CKD IIa has no eGFR floor; labels cover all non-dialysis CKD. Few G4 patients in trials. | Recommended Re-dose when iron deficiency recurs. |
| G5 | Allowed Labels permit IV iron in non-dialysis CKD of any stage, but HF trials required eGFR >=15; HF benefit at G5 is extrapolated. | Allowed Continue per iron indices; nephrology anaemia targets apply. |
| dialysis | Allowed IV iron is standard nephrology practice in haemodialysis (ESC CVD-CKD Class I proactive high-dose IV iron, PIVOTAL with iron sucrose); FCM/FDI are not labelled for dialysis-dependent CKD and HF trials excluded dialysis. | Allowed Continue under nephrology protocols; withhold if ferritin >700 or TSAT >=40%. |
| aki | No data No source addresses IV iron during AKI; renal elimination of iron is negligible. Avoid during active systemic infection (KDIGO). | No data No source addresses AKI; a scheduled dose may be deferred to clinical judgement. |
| transplant | Use with caution KDIGO 2026: FCM raises FGF23 and causes hypophosphataemia; monitor phosphate especially in kidney transplant recipients (who are prone to post-transplant hypophosphataemia). | Use with caution Monitor phosphate with repeat FCM doses; consider a non-FGF23-raising formulation. |
Cutoffs recorded from the sources
- other < 100 ng/mL → recommended (initiate; ferric-carboxymaltose, ferric-derisomaltose)“In patients with HF, ID has been defined as either ferritin <100 ng/mL, or ferritin 100–299 ng/mL with TSAT <20%.” — esc2026, p. 66
- other < 20 % TSAT (when ferritin 100-299 ng/mL) → recommended (initiate; ferric-carboxymaltose, ferric-derisomaltose)“In patients with HF, ID has been defined as either ferritin <100 ng/mL, or ferritin 100–299 ng/mL with TSAT <20%.” — esc2026, p. 66
- other < 20 % → recommended (initiate; ferric-carboxymaltose, ferric-derisomaltose)“The Task Force supports the use of this most recent definition of ID in patients with HF and recognizes the need for new trials investigating the efficacy of i.v. iron supplementation in patients with HF and ID as defined by TSAT <20%.” — esc2026, p. 67
- other < 50 % → recommended (initiate; ferric-carboxymaltose, ferric-derisomaltose)“(i) HFrEF: characterized by LVEF <50% and symptoms and/or signs of HF.” — esc2026, p. 16
- other >= 15 g/dL → no-data (initiate; ferric-carboxymaltose)“There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL.” — fda-ferric-carboxymaltose, Section 2.2 Recommended Dosage, Table 1
- egfr < 15 mL/min/1.73m2 → allowed (initiate; ferric-carboxymaltose, ferric-derisomaltose)“Patients were also required to have an eGFR ≥15 mL/min at enrolment and a haemoglobin (Hb) ≥9 to <13 g/dL for women and ≥9 to <14 g/dL for men.” — ahmed2026-ironman-renal, Methods
- other > 700 ng/mL (or TSAT >=40%) → not-recommended (hold; ferric-carboxymaltose, ferric-derisomaltose)“Proactive regular high-dose intravenous iron—irrespective of haemoglobin level, and unless the serum ferritin concentration is >700 μg/L or TSAT is ≥40%—is recommended in patients on maintenance haemodialysis to reduce risk of cardiovascular events, including HF.” — esc2026-ckd, p. 67
- other < 3 months since prior FCM course → caution (uptitrate; ferric-carboxymaltose)“Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a repeat course of therapy within three months” — fda-ferric-carboxymaltose, Section 2.1 Laboratory Testing
Trial evidence (informational)
- CONFIRM-HF · HF LVEF <45%, NYHA II/III, ID (n=304)6MWD at 24 weeks: +25 m (95% CI 7-43) vs placebo“The mean change in 6MWD from Baseline to Week 24 in Injectafer-treated patients was 18 meters (95% CI 4, 32), and placebo-treated patients was -7 meters (95% CI -21, 7), with between group difference of 25 meters (7, 43), p-value 0.007, favoring Injectafer.” — fda-ferric-carboxymaltose, Section 14.2 Iron Deficiency in Heart Failure
- AFFIRM-AHF and IRONMAN · HFrEF with ID (AFFIRM-AHF after acute HF)CV death or total HFH: Primary endpoint missed; benefit in prespecified COVID-19 analyses“The AFFIRM-AHF and IRONMAN trials, testing i.v. ferric carboxymaltose and i.v. ferric derisomaltose vs placebo, respectively, in patients with HFrEF and iron deficiency (ID) failed to meet the primary composite endpoint of CV death or total HFH, despite a point estimate suggesting benefit.” — esc2026-supp, p. 32
- IRONMAN · HF LVEF <=45%, TSAT <20% or ferritin <100 (n=1137)Total HFH and CV death: RR 0.82 (95% CI 0.66-1.02)“After a median follow-up of 2.7 years, the rate ratio for the primary endpoint, a composite of total (first and recurrent) HF hospitalizations and CV death, was 0.82 (95% CI 0.66–1.02; P = .070).” — esc2023-update, p. 10
- HEART-FID · Ambulatory HF LVEF <=40% with IDHierarchical death/HFH/6MWD: Neutral“In the HEART-FID trial, i.v. ferric carboxymaltose did not reduce the hierarchical composite endpoint of death from any cause or HFH within 12 months, and change in the 6MWD at 6 months in ambulatory patients with HF, an LVEF ≤40%, and ID.” — esc2026-supp, p. 33
- FAIR-HF2 · HF LVEF <=45% with ID (n=1105)CV death or first HFH: HR 0.79 (95% CI 0.63-0.99)“CV death or first HFH (first primary outcome) occurred in 141 in the ferric carboxymaltose group vs 166 in the placebo group (HR 0.79, 95% CI 0.63 to 0.99; P = .04).” — esc2026-supp, p. 33
- IPD meta-analysis (CONFIRM-HF, AFFIRM-AHF, HEART-FID), 2023 · 4501 patients with HF and IDCV death and total CV hospitalizations: RR 0.86 (95% CI 0.75-0.98)“Ferric carboxymaltose therapy compared with placebo significantly reduced the co-primary composite endpoint of CV death and total CV hospitalizations (RR 0.86; 95% CI 0.75–0.98; P = .029), without evidence of heterogeneity by trial (Figure 2A).” — ponikowski2023-ipd, Results: Recurrent event efficacy endpoints
- Bayesian IPD meta-analysis of 6 trials (incl. FAIR-HF2), 2025 · 7175 patients with HF and IDRecurrent HFH and CV death: RR 0.72 (0.55-0.89) at 12 months; 0.81 (0.63-0.97) overall; CV death alone not significant“A meta-analysis of six trials (FAIR-HF, CONFIRM-HF, AFFIRM-AHF, IRONMAN, HEART-FID and FAIR-HF2), including 7175 patients, showed that patients assigned to i.v. iron, compared with those assigned to placebo, had lower rates for the composite endpoint of recurrent HFH and CV mortality at 12 months [risk ratio (RR) 0.72, 95% CI 0.55 to 0.89] and for the complete length of follow-up (RR 0.81, 95% CI 0.63 to 0.97).” — esc2026-supp, p. 33
Acute kidney injury
No AKI-specific guidance found; iron is not renally eliminated. Avoid IV iron during active systemic infection.
“Avoid administering IV iron to patients with active systemic infections.”
KDIGO 2012 Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int Suppl 2012;2:279-335 (2012)· p. 13 Source
Dialysis
IV iron is standard of care in haemodialysis (PIVOTAL; ESC CVD-CKD Class I; KDIGO 2026 i.v. preferred in G5HD). HF ID trials (FAIR-HF2, IRONMAN) excluded dialysis/eGFR <15; FCM and FDI labels are restricted to non-dialysis CKD, while iron sucrose is labelled for HDD-CKD.
Trials: PIVOTAL, PIVOTAL HF analysis (Jhund 2021)
“In the PIVOTAL trial, a high-dose i.v. iron regimen, compared with a low-dose regimen, reduced the occurrence of first and recurrent HF events in patients undergoing dialysis for end-stage CKD.”
“However, for patients receiving haemodialysis in whom regular use of IV iron together with prescription of erythropoiesis-stimulating agents is the standard of care, the PIVOTAL trial showed that higher doses of IV iron reduced CV events and improved survival compared to lower doses [21].”
Ahmed FZ et al. Effects of Ferric Derisomaltose in Heart Failure with Iron Deficiency according to Renal Function in the IRONMAN Randomised Controlled Trial. Am J Nephrol 2026 (2026)· Discussion Source“Although PIVOTAL used iron sucrose specifically, in the judgment of the KDIGO Work Group, the benefits of the proactive regimen likely extend to other i.v. iron formulations.”
Babitt JL et al. Executive summary of the KDIGO 2026 Clinical Practice Guideline for the Management of Anemia in CKD. Kidney Int 2026;109:44-56 (2026)· p. 8 Source“Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).”
“Proactive regular high-dose intravenous iron—irrespective of haemoglobin level, and unless the serum ferritin concentration is >700 μg/L or TSAT is ≥40%—is recommended in patients on maintenance haemodialysis to reduce risk of cardiovascular events, including HF.”
2026 ESC Guidelines for the management of cardiovascular disease and chronic kidney disease, in collaboration with the ERA (2026)· p. 67, Section 12.2 Source“adult patients who have non-dialysis dependent chronic kidney disease.”
Kidney transplant
KDIGO 2026: monitor phosphate in kidney transplant recipients given FGF23-raising preparations such as ferric carboxymaltose.
“Phosphate levels should therefore be monitored in people receiving these agents, particularly in earlier stages of CKD, kidney transplant recipients, and people receiving repeated doses.”
Babitt JL et al. Executive summary of the KDIGO 2026 Clinical Practice Guideline for the Management of Anemia in CKD. Kidney Int 2026;109:44-56 (2026)· p. 8 Source“Ferric carboxymaltose did not improve exercise capacity or most secondary outcomes, arguing against routine supplementation to improve functional capacity.”
Vinke JSJ et al. Ferric carboxymaltose and exercise capacity in iron-deficient kidney transplant recipients: RCT. EClinicalMedicine 2026 (PMC13571158) (2026)· Summary, Interpretation Source
Albuminuria
No source makes an albuminuria-dependent statement for IV iron.
No verbatim statement found for this cell.
Monitoring
Observe >=30 min for hypersensitivity after each infusion; monitor BP after FCM (transient hypertension); check phosphate before repeat FCM courses (boxed warning 08/2026); reassess ferritin/TSAT (and Hb) to guide re-dosing; serum iron is overestimated for 24 h after FCM.
“INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention”
“Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion.”
“Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy.”
“Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.”
In-hospital initiation
ESC 2026: the pre-discharge phase after HF hospitalization may be used for IV iron (AFFIRM-AHF).
“If not done earlier, the predischarge phase may also be used for iron supplementation in patients with iron deficiency (ID), based on the results of the AFFIRM-AHF trial (see Section 10.4).”
Outpatient
Ambulatory symptomatic HFrEF with ID (CONFIRM-HF, IRONMAN, HEART-FID, FAIR-HF2). ACC 2024 HFrEF pathway: consider IV iron for symptom improvement.
“Consider intravenous iron replacement for symptom improvement”
Where sources disagree
Strength of recommendation for symptoms/QoL and HFH
“Intravenous iron supplementation is recommended in patients with symptomatic HFrEF and iron deficiency to alleviate HF symptoms and improve QoL.”
“Intravenous iron supplementation is recommended in symptomatic patients with HFrEF and HFmrEF, and iron deficiency, to alleviate HF symptoms and improve quality of life.”
“In patients with HFrEF and iron deficiency with or without anemia, intravenous iron replacement is reasonable to improve functional status and QOL”
“Given the conflicting results of major RCTs, the position of the Task Force is that evidence regarding the benefits of i.v. iron supplementation on strong endpoints is not conclusive.”
Tool uses esc2026: ESC-centric: Class I for symptoms/QoL, IIa for HFH (unchanged in class from ESC 2023 but LoE now B1). Show AHA 2022 Class 2a as the ACC/AHA view. FDA label (FCM) supports exercise capacity only.
Definition of iron deficiency
“In patients with HF, ID has been defined as either ferritin <100 ng/mL, or ferritin 100–299 ng/mL with TSAT <20%.”
“An optimal definition of iron deficiency in the HF setting remains to be identified but the body of evidence increasingly favours a streamlined definition that relies solely on a TSAT value <20%.”
2026 ESC Guidelines for the management of cardiovascular disease and chronic kidney disease, in collaboration with the ERA (2026)· p. 39 Source“Iron deficiency was defined as serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%. Patients with Hb of ≥ 15 g/dl were excluded.”
INJECTAFER (ferric carboxymaltose) PI, American Regent (2026)· Section 14.2 Iron Deficiency in Heart Failure Source“Iron supplementation in patients with CKD not on dialysis is reasonable when ferritin is <100 µg/L and transferrin saturation (TSAT) <40%, or ferritin 100–300 µg/L with TSAT <25%”
2026 ESC Guidelines for the management of cardiovascular disease and chronic kidney disease, in collaboration with the ERA (2026)· p. 20 Source
Tool uses esc2026: Default to the trial definition (ferritin <100, or 100-299 with TSAT <20%) used in the ESC recommendation tables and the FCM label; display the TSAT <20%-only definition as an ESC-endorsed alternative (user-selectable). CKD anaemia thresholds (KDIGO/ESC CVD-CKD) are for anaemia management, not the HF indication.
Dialysis: label scope vs nephrology guidance vs HF trial exclusions
“who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)”
“Proactive regular high-dose intravenous iron (e.g. iron sucrose) is recommended in patients on maintenance haemodialysis, unless the serum ferritin concentration is >700 μg/L or transferrin saturation is ≥40%, to reduce risk of”
2026 ESC Guidelines for the management of cardiovascular disease and chronic kidney disease, in collaboration with the ERA (2026)· p. 69 Source“Use of renal replacement therapy”
Anker SD et al. Rationale and design of the FAIR-HF2-DZHK05 trial. Eur J Heart Fail 2025 (2025)· Table 1 Main exclusion criteria Source“Although PIVOTAL used iron sucrose specifically, in the judgment of the KDIGO Work Group, the benefits of the proactive regimen likely extend to other i.v. iron formulations.”
Babitt JL et al. Executive summary of the KDIGO 2026 Clinical Practice Guideline for the Management of Anemia in CKD. Kidney Int 2026;109:44-56 (2026)· p. 8 Source
Tool uses esc2026-ckd: IV iron in haemodialysis is Class I standard practice (iron sucrose); show 'allowed' with a note that FCM/FDI are outside their US labelled CKD indication in dialysis and that dosing follows nephrology protocols, not the HF ID definition.
Phenotype / LVEF range
“Most of the evidence refers to patients with left ventricular ejection fraction ≤45%.”
“(i) HFrEF: characterized by LVEF <50% and symptoms and/or signs of HF.”
“have demonstrated that iron supplementation with i.v. ferric carboxymaltose is safe and effective in improving symptoms and QoL in patients with HF and LVEF <40%–45%.”
Tool uses esc2026: Apply to the project's HFrEF branch (LVEF <50%) per ESC 2026, noting that trial evidence is LVEF <=45%; no recommendation for HFpEF.
Open questions
- Default ID definition in the tool: classic (ferritin <100, or 100-299 + TSAT <20%) vs TSAT <20% alone (ESC 2026 Task Force and ESC CVD-CKD favour TSAT-only). Make it a user setting?
- Dialysis cell set to 'allowed' (not 'recommended') because the ESC CVD-CKD Class I is for proactive iron sucrose to reduce CV events in haemodialysis, not for FCM/FDI as HF therapy. Confirm.
- G4 set to 'recommended' (labels cover all non-dialysis CKD, IRONMAN enrolled eGFR >=15) although G4 numbers were small; confirm vs 'allowed'.
- Transplant 'caution' is FCM-specific (hypophosphataemia); should the matrix split FCM vs FDI for transplant?
- HFpEF: no recommendation (FAIR-HFpEF small); show 'no recommendation' in the HFpEF branch?