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.

AI-generated actor
AI-generated actor

Injectafer® (ferric carboxymaltose
injection) improved exercise capacity for
certain patients with ID and HF1

Choose Injectafer To offer the most iron per course of treatment in Iron Deficiency Anemia (IDA) To improve exercise capacity in adult patients with NYHA Class II/III Heart Failure (HF) with Iron Deficiency (ID)*

  • The most-studied intravenous (IV) iron in the world†
  • Over 3 million US patients treated‡
*For iron deficiency anemia (IDA), one course of treatment is 2 doses of up to 750 mg separated by at least 7 days. For patients weighing less than 50 kg (110 lb), the recommended dosage is Injectafer 15 mg/kg body weight intravenously in 2 doses separated by at least 7 days per course.1
†Source: Trialtrove®, Mar 2021.2 ‡Source: Symphony Health Solutions claims data launch to Jan. 2024.2

Connect with a Representative for more information

Replenish your patients’ iron deficits with Injectafer

When oral iron fails, it may be time to consider an IV iron for your patients with IDA

Choose Injectafer (ferric carboxymaltose injection), the only FDA-approved IV iron approved to restore up to 1500 mg in 1 course of therapy. Injectafer is dosed in 2 administrations of up to 750 mg separated by at least 7 days.1 100% of IV iron is delivered into your patient's bloodstream. Injectafer is also available as a 100 mg iron/2 mL single-dose vial.1 See below for weight-based dosing.

Two Injectafer® (ferric carboxymaltose injection) 750 mg (50 mg/mL) IV Vials Artist's rendering.

Up to 1500 mg in one course of treatment§

Artist's rendering.

IV infusion over at least 15 minutes

Slow IV push over 7.5 minutes

§When administered via IV infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not <2 mg of iron per mL, and administer over at least 15 minutes. When administered as a slow IV push, give at the rate of approximately 100 mg (2 mL) per minute.1

Recommended weight-based dosing for adult patients with ID in HF NYHA class II/III to improve exercise capacity1

After determining your adult patients with HF and NYHA class II/III have ID, calculate the total iron needed using the dosing tables below1

Initial dose is based on hemoglobin (Hb) at baseline
Patients with lower Hb at baseline may require a week 6 dose
Reassess iron parameters at week 12. Maintenance dosing is recommended if ID is still present
DAY 1
Hb (g/dL) Patient body weight
<70 kg or ≥70 kg
≤14 1000 mg
14 and <15* 500 mg
WEEK 6*
Hb (g/dL)
Patient body weight
<70 kg ≥70 kg
<10 500 mg 1000 mg
≥10 to <15* no dose 500 mg

*No week 6 dose is needed for patients with a Hb (g/dL) ≥14.

WEEK 12, 24, AND 36†
Administer a maintenance
dose of 500 mg, if serum ferritin
<100 ng/mL or serum ferritin
100 ng/mL to 300 ng/mL
with Transferrin Saturation (TSAT) <20%

†There are no data available to guide Injectafer dosing past 36 weeks.

A majority of patients with HF received 1500 mg or more of Injectafer1,8

In CONFIRM-HF (a trial specific to ID treatment in certain HF patients) to determine whether intravenous Injectafer improves exercise capacity, the mean and median total dose was 1500 mg (with a dosing range of 500 mg-3500 mg iron).3

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

Diagnosing and Treating IDA

A wide variety of patient types should be tested for IDA based on clinical judgement

As of 2025, approximately 10 million adults in the United States have IDA4

Learn more about diagnosing and managing IDA

Review the efficacy and safety data from head-to-head pivotal trials

See the data

Patient Resource:

Download the Injectafer Patient Brochure

IDA and cancer

There is a 44% to 50% prevalence of IDA across tumor types, including hematological malignancies.5

IDA in women

In the United States, 1 in 5 women of childbearing age has IDA.6

IDA and gastrointestinal (GI) conditions

There is a 36% to 76% prevalence of IDA in patients with inflammatory bowel disease (IBD).7

ID in HF

~50% of all patients with HF have ID.8

IDA and NDD-CKD

57.88%–58.8% (of men) and 69.9%–72.8% (of women) with NDD-CKD have low iron tests (NHANES III).9||

||Defined in reference as serum ferritin <100 ng/mL or TSAT <20%. Authors concluded this remarkably high prevalence might indicate these indices may not be specific enough and may falsely identify too many patients as iron deficient.12

AR Assist® Patient Support Program

AR Assist Patient Assistance

Contact
AR Assist

AR Assist offers a suite of support programs to help appropriate patients access Injectafer therapy, including claims & appeals support and financial assistance programs for eligible patients.

Visit AR-Assist.com to download helpful resources. You can also connect live with an AR Assist Care Coodinator by calling 1-877-448-4766, Monday–Friday, 8:00 AM–6:00 PM ET.
Excluding holidays

Financial Assistance Programs

Injectafer Savings Program

Financial Assistance§§

Co-pay savings may help reduce eligible commercially insured patients out-of-pocket costs||||

Patients May Pay as Little as $50 per Dose

For eligible patients

  • Assistance of up to $500 per dose
  • Enrollment is valid for 2 courses of treatment per 12-month period
  • See applicable Terms and Conditions below

Patient Assistance Program

The Patient Assistance Program was created to help patients who lack health insurance or are commercially underinsured and cannot afford therapy.

For more information, including how to apply for your patients, visit AR-Assist.com.

§§Injectafer Savings Program is only available for patients aged 1 year or older who are commercially insured. Please see full Terms and Conditions at AR-Assist.com. ||||Insurance out-of-pocket payment must be over $50. Other restrictions may apply.

Injectafer Savings Program Terms and Conditions

  1. This offer is valid for commercially insured patients. Uninsured and cash-paying patients are NOT eligible for this Program.
  2. Depending on insurance coverage, eligible patients may pay no more than $50 per dose for up to four doses per calendar year. There is a maximum savings limit of $500 per dose, with an overall program limit of $2,000 per calendar year. Check with your pharmacist or healthcare provider for your co-pay discount. Patient out-of-pocket expense may vary.
  3. This offer is not valid for patients enrolled in Medicare Part B or Medicare Part D, Medicaid, or other federal or state healthcare programs, or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this card if they are Medicare-eligible and enrolled in an employer-sponsored health plan or medical or prescription drug benefit program for retirees.
  4. An explanation of benefits (EOB) statement must be faxed, uploaded in the portal, or mailed in prior to transacting on the account numbers for co-pay assistance.
  5. Offer is invalid for claims or transactions more than 180 days from the date on the EOB.
  6. Patients will be automatically re-enrolled in the next calendar year. If there is no copay claim activity for 18 months, the enrollment will be canceled.
  7. American Regent, Inc. reserves the right to rescind, revoke or amend this offer without notice. Offer good only in the USA, including Puerto Rico, at participating pharmacies or healthcare providers.
  8. Void if prohibited by law, taxed, or restricted.
  9. This account number is not transferable. The selling, purchasing, trading, or counterfeiting of this account number is prohibited by law.
  10. This account number is not insurance.
  11. By redeeming this account number, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
  12. Qualified patients receiving Injectafer will be allowed a 180-day retroactive enrollment period from the date of EOB (eligibility of benefit form) to receive benefits under the program rules.

Patient Assistance Program – Program Eligibility

Patients must meet all of the following to be eligible for the program: 1) meet established income requirements, 2) lack health insurance completely or be commercially underinsured, and 3) be a resident of the USA or its territories, including Puerto Rico.

References:

  1. Injectafer®. Package insert. American Regent, Inc.
  2. Data on file. American Regent, Inc., Shirley, NY.
  3. Ponikowski P, van Veldhuisen DJ, Com.n-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. Auerbach M, DeLoughery TG, Tirnauer JS. Iron Deficiency in Adults: A Review. JAMA. 2025 May 27;333(20):1813-1823. doi: 10.1001/jama.2025.0452. PMID: 40159291.
  5. Ludwig H, Müldür E, Endler G, Hübl W. Prevalence of iron deficiency across different tumors and its association with poor performance status, disease status and anemia. Ann Oncol. 2013;24(7):1886-1892. doi:10.1093/annonc/mdt118
  6. Your guide to anemia. National Heart, Lung, and Blood Institute. Published September 2011. Accessed August 23, 2023. https://www.nhlbi.nih.gov/sites/default/files/publications/11-7629.pdf
  7. Stein J, Hartmann F, Dignass AU. Diagnosis and management of iron deficiency anemia in patients with IBD. Nat Rev Gastroenterol Hepatol. 2010;7(11):599-610. doi:10.1038/nrgastro.2010.151
  8. Ebner N, von Haehling S. Why is iron deficiency recognized as an important comorbidity in heart failure? Card Fail Rev. 2019;5(3):173-175. doi:10.15420/cfr.2019.9.2
  9. Fishbane S, Pollack S, Feldman HI, Joffe MM. Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988–2004. Clin J Am Soc Nephrol. 2009;4(1):57-61.

  • 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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Injectafer® and the Injectafer® logo are trademarks of Vifor (International) Inc., Switzerland. Injectafer® is manufactured under license from Vifor (International) Inc., Switzerland. Trademarks not owned by American Regent, Inc. or Vifor (International) are the property of their respective owners. This site is intended for US healthcare professionals.

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