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 safety data from Injectafer pivotal trials.

See BOXED WARNING related to symptomatic hypophosphatemia.

Adverse reactions from Injectafer adult pivotal trials 1 and 21

Adverse reactions reported in ≥1% of patients in adult pivotal trials 1 and 21
Term Injectafer
(N=1775) %		 Pooled comparators*
(N=1783) %		 Oral iron
(N=253) %
Nausea 7.2 2 1.2
Hypertension† 4 2 0.4
Flushing† 4 0.2 0
Injection site reactions† 3 3.2 0
Erythema† 3 0.6 0
Hypophosphatemia 2.1 0.1 0
Dizziness† 2.1 1.3 0.4
Vomiting 2 1 0.4
Injection site discoloration‡ 1.4 0.3 0
Headache† 1.3 1.2 0.4
Hepatic enzyme increased† 1.2 0.2 0
Dysgeusia† 1.2 2.1 0
Hypotension 1 2 0
Rash† 1 0.3 0
Constipation 0.5 0.9 3.2
*Includes oral iron and all formulations of intravenous (IV) iron other than Injectafer.1 †Grouped Terms by FDA Medical Query (FMQ).1 ‡Injection site discoloration was also included in the local administration reactions grouped term.1

Adverse reactions from Injectafer pediatric clinical trial 31

The safety of Injectafer in pediatric patients was evaluated in a randomized, active-controlled study (n=40).

Adverse reactions of any grade in pediatric patients receiving Injectafer in Study 31
Injectafer
(n=40) %		 Oral ferrous sulfate
(n=38) %
Any adverse reactions 35 26
Hypophosphatemia* 13 0
Injection site reactions* 8 0
Rash* 8 0
Headache 5 3
Vomiting 5 3
Nasopharyngitis 3 5
Flushing 3 0
Gastrointestinal infections 3 0
Liver function test increased 3 0
Platelet count decreased 3 0
White blood cell count
decreased		 3 0
  • Most treatment-emergent adverse events (TEAEs) in both treatment groups of the pivotal pediatric trial were mild in severity. There were no serious adverse events or deaths.1,2
  • Data from pivotal trials in adults showed a rate of serious anaphylactic/anaphylactoid reactions of 0.1% (2/1775)1,2
  • The safety and effectiveness of Injectafer for IDA in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established. Use of Injectafer for this indication in this age group is supported by evidence from adequate and well-controlled studies of Injectafer in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older.

*Grouped terms. Injection site reactions include infusion site hematoma, infusion site hypoesthesia, and injection site pain. Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased. Rash includes rash, exanthema and urticaria.1

CONFIRM-HF Safety Study

Adverse reactions of Injectafer across the iron deficiency (ID) and heart failure (HF) clinical trials

In clinical trials evaluating Injectafer in adult patients with ID and HF (1016 patients received Injectafer vs 857 received placebo), the overall adverse events of Injectafer was consistent across the studied indications.1

Adverse events (AE) in CONFIRM-HF3
Safety endpoint or event Injectafer (n=152)
n (%) events 		Placebo (n=152)
n (%) events
Subject with at last one drug-related AE 14 (9.2) 24 5 (3.3) 7
General disorders and administration site conditions 9 (5.9) 9 2 (1.3) 2
Skin and subcutaneous tissue disorders 4 (2.6) 4 0 (0.0) 0
Nervous system disorders 2 (1.3) 3 1 (0.7) 1
Gastrointestinal disorders 2 (1.3) 3 0 (0.0) 0
Vascular disorders 1 (0.7) 2 1 (0.7) 1
Investigations 1 (0.7) 1 2 (1.3) 2
Ear and labyrinth disorders 1 (0.7) 1 0 (0.0) 0
Injury, poisoning and procedural complications 1 (0.7) 1 0 (0.0) 0
Cardiac disorders 0 (0.0) 0 1 (0.7) 1

%=percentage of above in the total number of subjects in the group; events=total number of events; n=number of subjects experiencing at least one time the considered event.

Please see the Important Safety Information including BOXED WARNING on symptomatic hypophosphatemia, below.

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In all pivotal trials, Injectafer did not exclude patients with multiple drug allergies or intolerance to other IV irons4,5

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. In clinical studies, hypertension was reported in 4% (67/1775) of subjects. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea, were observed in 6% (106/1775) of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes.1

Please see the Important Safety Information including BOXED WARNING on symptomatic hypophosphatemia, below.

References:

  1. Injectafer®. Package insert. American Regent, Inc.
  2. Data on file. American Regent, Inc., Shirley, NY.
  3. Ponikowski P, van Veldhuisen DJ, Comín-Colet 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
  4. Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306-315.
  5. Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014;29(4):833-842.

  • 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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