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.

Treating and managing iron deficiency and iron deficiency anemia

Treatment options for patients who need iron replenishment.1

  • About Oral iron

    Oral iron therapy is often the first line of treatment for patients with IDA. However, there are several reasons why oral iron may not be the right option for some patients.1,2,3

    Absorption

    • The digestive tract is only able to absorb a small portion of the iron in an oral iron supplement, so your body may not get the full dose of iron needed.
    • A wide variety of inflammatory conditions can hinder oral iron absorption and reduce serum iron levels
    A pill with 10% shaded red

    EVEN IN HEALTHY PATIENTS, LESS THAN 10% OF ORAL IRON IS ABSORBED1,4*

    *A typical dose is a 300-mg ferrous sulfate tablet or 320-mg ferrous gluconate tablets (taken 3 to 4 times daily). Approximately 10% of oral iron is absorbed.1

    Adherence

    • Data shows that the adherence rate for oral iron therapy is 40% to 60%.2
    • Adherence may be affected by side effects.3

    Side Effects

    • Patients taking oral iron may experience side effects including nausea, vomiting , constipation and diarrhea.5
    • Nausea and vomiting may occur with higher doses, but they can usually be controlled by taking the iron in smaller amounts.

  • About IV iron

    With IV iron treatment, the full dose of IV iron is available to be utilized in Hb production or stored as ferritin for use when Hb is depleted.6

    Oral iron intolerance or failed therapy

    • For IDA patients who are intolerant to or fail oral iron therapy, IV iron may be an option
    • Oral iron therapy has not been proven effective in iron replacement and did not improve exercise capacity for heart failure patients with ID and reduced ejection fraction (HFrEF)7,8, but IV iron has been.

    WITH IV IRON,

    100% with an IV bag

    delivered into the bloodstream

    Adherence

    • Patients requiring multiple doses may be lost to follow up

    Injectafer Side effects9

    • 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.

  • About Oral iron

    Learn more

  • About IV
    Iron

    Learn more

Oral iron therapy is often the first line of treatment for patients with IDA. However, there are several reasons why oral iron may not be the right option for some patients.1,2,3

Poor absorption

  • The digestive tract is only able to absorb a small portion of the iron in an oral iron supplement, so your body may not get the full dose of iron needed.
  • A wide variety of inflammatory conditions can hinder oral iron absorption and reduce serum iron levels
A pill with 10% shaded red

EVEN IN HEALTHY PATIENTS, LESS THAN 10% OF ORAL IRON IS ABSORBED1,4*

*A typical dose is a 300-mg ferrous sulfate tablet or 320-mg ferrous gluconate tablets (taken 3 to 4 times daily). Approximately 10% of oral iron is absorbed.1

Adherence

  • Data shows that the adherence rate for daily oral iron therapy is 40% to 60%.2
  • Adherence may be affected by side effects.3

Side Effects

  • Patients taking oral iron may experience side effects including nausea, vomiting , constipation and diarrhea.5
  • Nausea and vomiting may occur with higher doses, but they can usually be controlled by taking the iron in smaller amounts.

With IV iron treatment, the full dose of IV iron is available to be utilized in Hb production or stored as ferritin for use when Hb is depleted.6

Oral iron intolerance or failed therapy

  • For patients who are intolerant to or fail oral iron therapy, IV iron may be an option
  • Oral iron therapy was not proven to be effective in iron repletion and did not improve exercise capacity for the treatment of ID in patients withpheart/failure with reduced ejection fraction (HFrEF)7,8 but IV iron can.

WITH IV IRON,

100% with an IV bag

delivered into the bloodstream

Injectafer Side effects9

  • 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.

Consider routinely testing across all 3 key indices to determine if your patients' iron treatment is working2,3 

Hb
Ferritin
TSAT
NDD-CKD, Non-Dialysis Dependent Chronic Kidney Disease; Hb, hemoglobin; TSAT, transferrin saturation

References:

  1. Zhu A, Kaneshiro M, Kaunitz JD. Evaluation and treatment of iron deficiency anemia: a gastroenterological perspective. Dig Dis Sci. 2010;55(3):548-559. doi:10.1007/s10620-009-1108-6
  2. Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, et al. Tolerability of different oral iron supplements: a systematic review. Curr Med Res Opin. 2013;29(4):291-303. doi:10.1185/03007995.2012.761599
  3. Bloor SR, Schutte R, Hobson AR. Oral iron supplementation gastrointestinal side effects and the impact on the gut microbiota. Microbiol Res. 2021;12:491-502. doi.org/10.3390/ microbiolres12020033
  4. Iron supplementation in pediatrics. Academy of Family Physicians, University of Washington. Accessed August 23, 2023. https://depts.washington.edu/nutr/wordpress/wp-content/uploads/2015/03/Iron-in-Pediatrics_2012.pdf
  5. U.S. National Library of Medicine. “Taking Iron Supplements.” MedlinePlus. Accessed March 31, 2026. https://medlineplus.gov/ency/article/007478.htm.
  6. Geisser P, Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics. 2011;3(1):12-33. doi:10.3390/pharmaceutics3010012
  7. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(17):e263-e421. doi:10.1016/j. jacc.2021.12.012
  8. Lewis GD, Molhotra R, Hernandez AF, et al. Effect of oral iron repletion on exercise capacity in patients with heart failure with reduced ejection fraction and iron deficiency: the IRONOUT HF randomized clinical trial. JAMA. 2017;317(19):1958-1966. doi:10.1001/jama.2017.5427
  9. 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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