Indications

Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

EFFICACY & SAFETY

Review the data from pivotal CONFIRM-HF trial: a randomized, double-blind, placebo-controlled, multicenter study in patients with iron deficiency and chronic heart failure1

A total of 304 patients were randomized and treated.1

Injectafer-Treated Patients VS Placebo-Treated Patients icon
  • 53% were classified as New York Heart Association (NYHA) class II1
  • 47% were classified as NYHA class III1
  • The median age of study patients was 71 years (range, 35 to 88)1
  • 45% were female1
  • 99% were Caucasian1
Baseline mean (SD)1
Hemoglobin (Hb) Ferritin Transferrin Saturation (TSAT) LVEF Brain natriuretic peptide
12 g/dL (1.4) 57 ng/mL (48) 20% (18) 37% (7) 772 pg/mL (995)

At baseline, 95% of patients were treated with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), 91% with beta-blocker, 59% with aldosterone antagonists, and 90% with diuretic.1

Key Criteria1

Heart icon
HF: NYHA functional class Ⅱ or Ⅲ (due to stable symptomatic chronic heart failure (HF)); LVEF ≤45%
Low ferritin icon
Iron deficiency: Hb < 15g/dL; serum ferritin <100 ng/mL (or 100 ng/mL-300 ng/mL with TSAT <20%)

Primary Efficacy Endpoint1*

  • Change in 6MWT distance from baseline to week 24

*Secondary endpoints included: change in patient global assessment, change in NYHA functional class, change in 6MWT (from baseline to weeks 6, 12, 36 and 52), change in fatigue score, change in Kansas City Cardiomyopathy Questionnaire, change in European Quality of Life 5D (EQ-5D) questionnaire, time to first hospitalization due to worsening HF, and rates of any hospitalization.

6MWT=6-minute walk test, which is also referred to as the 6-minute walk distance (6MWD). LVEF=left ventricular ejection fraction.

CONFIRM-HF TRIAL:

Injectafer significantly improved 6MWT2

Improvements in 6MWT at 24 weeks2,3

Graph indicating improvements in 6-minute walk test at 24 weeks with Injectafer® (ferric carboxymaltose injection)
Graph indicating improvements in 6-minute walk test at 24 weeks with Injectafer® (ferric carboxymaltose injection)

Increases in ferritin, TSAT, and Hb at week 241

  • At baseline, mean (SD) ferritin was 57 ng/mL (45). Change from baseline to week 24 in ferritin was 265 ng/mL(250, 288)1
  • At baseline, mean (SD) TSAT was 20% (17.6). Change from baseline to week 24 in TSAT was 9% (7, 11)1
  • At baseline, mean (SD) Hb was 12 g/dL (1.4). Change from baseline to week 24 in Hb was 0.6 g/dL (0.3, 0.8)1

6MWT=6 Minute Walk Test

Safety Profile

References:

  1. Ponikowski P, van Veldhuisen DJ, Comín-Cole J, 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):657-668. doi:10.1093/eurheartj/ehu385
  2. Injectafer®. Package insert. American Regent, Inc.

  • IMPORTANT SAFETY INFORMATION

    WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA
    • INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia, and fractures requiring clinical intervention.
    • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia.
    • 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. Correct pre-existing hypophosphatemia prior to administering INJECTAFER.
    • Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures).

    CONTRAINDICATIONS

    INJECTAFER is contraindicated in patients with hypersensitivity to INJECTAFER or any of its inactive components.

    WARNINGS AND PRECAUTIONS

    Symptomatic Hypophosphatemia

    Symptomatic hypophosphatemia, including severe cases, with serious outcomes such as osteomalacia and fractures requiring clinical intervention have occurred in patients treated with INJECTAFER in the post-marketing setting. These cases have occurred after single and multiple doses of INJECTAFER. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). However, individuals without apparent risk factors have experienced symptomatic hypophosphatemia. In most cases, hypophosphatemia resolved within three months.

    Check serum phosphate levels prior to a repeat course of treatment if the patient is at risk for low serum phosphate or if the patient will receive a repeat course of therapy within three months of the prior course. Correct pre-existing hypophosphatemia prior to administering INJECTAFER. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated.

    Consider permanent discontinuation of INJECTAFER for severe symptomatic hypophosphatemia or persistent hypophosphatemia.

    Hypersensitivity Reactions

    Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving INJECTAFER. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. 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. Only administer INJECTAFER when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving INJECTAFER. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.

    Hypertension

    In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each INJECTAFER administration.

    Laboratory Test Alterations

    In the 24 hours following administration of INJECTAFER, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in INJECTAFER.

    ADVERSE REACTIONS

    The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.

    The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting.

    Post-Marketing Experience

    Adverse reactions have been identified during post approval use of INJECTAFER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    The following adverse reactions have been reported from the post-marketing spontaneous reports with INJECTAFER: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia; nervous system disorders: syncope; respiratory, thoracic, and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

    USE IN SPECIFIC POPULATIONS

    Pregnancy – Fetal/Neonatal Adverse Reactions

    Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as INJECTAFER) which may cause fetal bradycardia, especially during the second and third trimester.

    INDICATIONS

    INJECTAFER® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. INJECTAFER is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

    Please see Full Prescribing Information including BOXED WARNING

    You are encouraged to report Adverse Drug Events to American Regent, Inc.® at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

    REF-2472 (v8.0) 8/2026

    Please see Full Prescribing Information including BOXED WARNING

IMPORTANT SAFETY INFORMATION

WARNING: SYMPTOMATIC HYPOPHOSPHATEMIA
  • INJECTAFER can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia, and fractures requiring clinical intervention.
  • Hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors for hypophosphatemia.
  • 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. Correct pre-existing hypophosphatemia prior to administering INJECTAFER.
  • Advise patients receiving INJECTAFER about the risk of hypophosphatemia and to report any signs and symptoms of hypophosphatemia (e.g., fatigue, muscle weakness or pain, bone and joint pain, bone fractures).

CONTRAINDICATIONS

INJECTAFER is contraindicated in patients with hypersensitivity to INJECTAFER or any of its inactive components.

WARNINGS AND PRECAUTIONS

Symptomatic Hypophosphatemia

Symptomatic hypophosphatemia, including severe cases, with serious outcomes such as osteomalacia and fractures requiring clinical intervention have occurred in patients treated with INJECTAFER in the post-marketing setting. These cases have occurred after single and multiple doses of INJECTAFER. Risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). However, individuals without apparent risk factors have experienced symptomatic hypophosphatemia. In most cases, hypophosphatemia resolved within three months.

Check serum phosphate levels prior to a repeat course of treatment if the patient is at risk for low serum phosphate or if the patient will receive a repeat course of therapy within three months of the prior course. Correct pre-existing hypophosphatemia prior to administering INJECTAFER. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Treat hypophosphatemia as medically indicated.

Consider permanent discontinuation of INJECTAFER for severe symptomatic hypophosphatemia or persistent hypophosphatemia.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving INJECTAFER. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. 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. Only administer INJECTAFER when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving INJECTAFER. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.

Hypertension

In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each INJECTAFER administration.

Laboratory Test Alterations

In the 24 hours following administration of INJECTAFER, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in INJECTAFER.

ADVERSE REACTIONS

The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.

The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting.

Post-Marketing Experience

Adverse reactions have been identified during post approval use of INJECTAFER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported from the post-marketing spontaneous reports with INJECTAFER: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia; nervous system disorders: syncope; respiratory, thoracic, and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

USE IN SPECIFIC POPULATIONS

Pregnancy – Fetal/Neonatal Adverse Reactions

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as INJECTAFER) which may cause fetal bradycardia, especially during the second and third trimester.

INDICATIONS

INJECTAFER® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. INJECTAFER is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Please see Full Prescribing Information, including BOXED WARNING.

You are encouraged to report Adverse Drug Events to American Regent, Inc.® at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

REF-2472 (v8.0) 8/2026

Please see Full Prescribing Information including BOXED WARNING

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