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.

Dosing &
Administering Injectafer

Replenish your patients’ iron deficits with Injectafer

Injectafer 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 as a first line treatment for adult patients who have non-dialysis-dependent chronic kidney disease. Injectafer is also indicated as a first line treatment for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.1

Injectafer provides the most iron per course of treatment— up to 1500 mg in 2 doses of up to 750 mg separated by at least 7 days.1 Injectafer is also available as a 100 mg iron/2 mL single-dose vial.1

      Artist’s rendering.

Up to1500 mg*† in one course of treatment

Artist’s rendering.

Intravenous (IV) infusion over at least 15 minutes

Slow IV push over 7.5 minutes

*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. †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 below. Refer to the Full Prescribing Information1

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 Injectafer1,2

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

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

Evidence for administering 1500 mg of iron per course of treatment2

In 7 clinical trials including over 4600 patients, average iron deficits were ≈1500 mg2.

Average calculated iron deficits in Injectafer clinical trials‡

Bar chart showing average calculated iron deficits in Injectafer clinical trials, with study values ranging from 1352 mg to 1608 mg across different patient groups.
Bar chart showing average calculated iron deficits in Injectafer clinical trials, with study values ranging from 1352 mg to 1608 mg across different patient groups.
‡Studies 1-5 utilized a modified Ganzoni formula to determine dose requirements, while Studies 6 and 7 (2 larger pivotal studies) used 1,500 mg IV iron per study protocol and calculated iron deficits as a post hoc analysis. Reported etiologies included CKD, HUB (now commonly referred to as abnormal uterine bleeding or AUB), GI-related conditions, postpartum, and other/unknown.8 #Reported etiologies included HUB (now commonly referred to as AUB), GI disorders, postpartum, nutritional or dietary deficiency, and other.9,10

Injectafer is the only FDA-approved IV iron that restores up to 1500 mg of iron
in 2 administrations of up to 750 mg separated by at least 7 days1-6

Injectafer is available in a
750 mg iron/15 mL single-dose vial and a 100 mg iron/2 mL single-dose vial. 1

Not actual size.

Prior to Administration

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  • Infusion bag size

    Dilute Injectafer in up to 250 mL (but not more than) of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL.1 If you need further guidance, visit www.americanregent.com/medical-affairs.

  • Needle size

    The infusion nurse or administering healthcare professional should assess the patient's vein status and choose an appropriate gauge needle. If you need further guidance, visit www.americanregent.com/medical-affairs.

  • Mixing Injectafer

    Dilute up to 750 mg of Injectafer in up to 250 mL (but not more than) of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL. Administer over at least 15 minutes.1

    At concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.1

    Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.1

  • Storage prior to use

    Store Injectafer at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.1

Administration

Expand All Collapse All

  • Dosing for patients with IDA who weigh 50 kg or more

    Dosing for patients with IDA who weigh 50 kg (110 lb) or more: Give Injectafer in 2 doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose of 1500 mg of iron per course.1

    For your adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be given as a single-dose per course

  • Dosing for patients with IDA who weigh less than 50 kg

    Dosing for patients with IDA who weigh less than 50 kg (110 lb): Give Injectafer in 2 doses separated by at least 7 days. Give each dose as 15 mg/kg body weight.1

  • Dosing for adult patients with ID and HF NYHA class II/III to improve exercise capacity

    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.

  • Administering by IV push

    Injectafer may be administered as an undiluted slow IV push. Give at the rate of approximately 100 mg (2 mL) per minute.1

  • Special precautions

    Injectafer should only be administered when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.1

  • Occurrence of extravasation

    Monitor for extravasation, and if it occurs, discontinue the Injectafer administration at that site immediately.1

  • Most common side effects of Injectafer

    • The most common side effects in adults of Injectafer in the pivotal trials (reported by >2% of study patients) were: nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); dizziness (2.1%); and vomiting (2%)1
    • The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting.1
    • In pivotal trials 1 and 2 for Injectafer in adults, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer1
    • In pivotal trials for Injectafer, patients with multiple drug allergies or intolerance to other IV irons were not excluded.

    Review the most common adverse events reported during pivotal trials

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

References:

  1. Injectafer®. Package insert. American Regent, Inc.
  2. Koch TA, Myers J, Goodnough LT. Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations. Anemia. 2015. doi:10.1155/2015/763576
  3. Ponikowski P, van Veldhuisen DJ, Comin-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.

  • 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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