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 to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.

First and only high dose IV iron approved for Pediatric Patients (1 year of age and older)

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Detecting and diagnosing IDA

The symptoms of IDA are often nonspecific and may be underreported. Some patients may be asymptomatic1

Common signs and symptoms of IDA may include2*:

  • Fatigue Icon

    Fatigue

  • Weakness Icon

    Weakness

  • Dizziness Icon

    Dizziness

  • Shortness of breath Icon

    Shortness of breath

Other signs and symptoms:

  • headache
  • chest pain
  • pale skin
  • arrhythmia
  • dizziness or lightheadedness
  • brittle nails
  • coldness in extremities
  • Pica (craving nonfood items such as dirt or ice)

In pediatric patients, the consequences of IDA can go beyond anemia alone; IDA may be associated with negative and potentially irreversible behavior and cognitive deficits.

The signs and symptoms of IDA can overlap with those of other conditions1,3-5

It is important to routinely test patients who are at risk for IDA for low iron stores, even when they aren't exhibiting symptoms1

*Injectafer is not indicated to treat the symptoms of IDA.6

3 key indices for evaluating IDA7,8

Hemoglobin (Hb): Hb production requires sufficient levels of stored iron and adequate TSAT.9

Ferritin: When the body requires more iron than the diet provides, ferritin supplies a reservoir from which iron can be metabolized.10

Transferrin saturation (TSAT): Transferrin transports iron throughout the body so it can be used to produce Hb. TSAT is decreased in patients with chronic iron deficiency.9,11

3 Key IDA art

Normal levels in healthy patients†

Adults

Hb12

M 13.5 g/dL-17.5 g/dL12

F 12.0 g/dL-15.5 g/dL12

Ferritin1

M 40 μg/L-300 μg/L13

F 20 μg/L-200 μg/L13

TSAT14

M 20%-50%7‡

F 20%-50%7‡

Pediatrics

Hb15§

M 10.9 g/dL-17.7 g/dL12

F 10.9 g/dL-15.0 g/dL12

Ferritin16¶

M 36 μg/L-311 μg/L1

F 36 μg/L-92 μg/L1

TSAT17#

M 22%-44%13‡

F 22%-44%13‡

It may also be important to test for total iron binding capacity (TIBC) to diagnose IDA.9
Normal values for TIBC range from:

  • 240 μg/dL to 450 μg/dL in healthy adult patients14
  • 268 μg/dL to 570 μg/dL in healthy male pediatric patients18
  • 268 μg/dL to 564 μg/dL in healthy female pediatric patients18

Please note TIBC values were not measured in pivotal trials for Injectafer.

†Normal lab values may vary based on patient characteristics/comorbidities and by laboratory. ‡Injectafer is not indicated to treat patients with chronic kidney disease (CKD) who are on dialysis or patients with anemia of chronic disease. For patients with CKD and anemia, guidelines issued by the National Kidney Foundation (NKF) define TSAT of 30% as a lower limit to begin treatment. Consult the NKF guidelines for a complete list of recommendations for lab values when starting treatment.6,20 §Hb: 1-5 years: 10.9-15.0 g/dL; 5-11 years: 11.9-15.0 g/dL; 11-18 years: 12.7-17.7 g/dL (male), 11.9-15.0 g/dL (female).15 Ferritin: 1-5 years: 36-84 ng/mL, >6 years: 36-311 ng/mL (male), 36-92 ng/mL (female).16 #TSAT (transferrin saturation): 13 months-10 years: 22-39%, 11-17 years: 27-44%.17

The Injectafer pivotal trials looked at absolute change in Hb as the primary endpoint—and also assessed changes in ferritin and TSAT as secondary endpoints.21,22

See the data

A wide variety of patient types should be tested for IDA

IDA and cancer

IDA and cancer

There is a 44% to 50% prevalence of IDA across tumor types, including hematological malignancies.23

 

malabsorption/insufficient absorption

IDA and gastrointestinal (GI) conditions

There is a 36% to 76% prevalence of IDA in patients with inflammatory bowel disease (IBD).25

Watch the Gastroenterology Educational Video
IDA in women

IDA in women§

In the United States, 1 in 5 women of childbearing age has IDA.6,24

Download the Women's Health Brochure
IDA and heart failure

IDA and heart failure

17% of patients with chronic heart failure (CHF) have iron deficiency and anemia.26

Download the IDA and Heart Failure Brochure
IDA and non-dialysis dependent chronic kidney disease

IDA and non-dialysis dependent chronic kidney disease (NDD-CKD)

There is a 58% to 73% prevalence of low iron tests in patients with NDD-CKD.27II Injectafer may be used as first-line treatment in adult patients with NDD-CKD.6

§Published studies and available data from postmarketing reports with intravenous Injectafer are insufficient to assess the risk of major birth defects and miscarriage. ||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.

References:

  1. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed April 29, 2021.
  2. Iron-deficiency anemia. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/iron-deficiency-anemia/symptoms-causes/syc-20355034. Accessed April 29, 2021.
  3. Anand IS, Chandrashekhar Y, Ferrari R, Poole-Wilson PA, Harris PC. Pathogenesis of oedema in chronic severe anaemia: studies of body water and sodium, renal function, haemodynamic variables, and plasma hormones. Br Heart J. 1993;70(4):357-362.
  4. Dumitru I. Heart failure clinical presentation. Medscape website. http://emedicine.medscape.com/article/163062-clinical. Updated March 2, 2021. Accessed April 29, 2021.
  5. Colorectal cancer symptoms. Cancer Treatment Centers of America® website. https://www.cancercenter.com/cancer-types/colorectal-cancer/symptoms. Accessed April 29, 2021.
  6. Injectafer [package insert]. Shirley, NY: American Regent, Inc.; February 2022.
  7. Kotze MJ, van Velden DP, van Rensburg SJ, Erasmus R. Pathogenic mechanisms underlying iron deficiency and iron overload: new insights for clinical application. EJIFCC. 2009;20(2):108-123.
  8. Kaitha S, Bashir M, Ali T. Iron deficiency anemia in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2015;6(3):62-72.
  9. Iron-deficiency anemia. American Society of Hematology website. https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed April 29, 2021.
  10. Ferritin blood test. Medline Plus website. https://medlineplus.gov/ency/article/003490.htm. Updated April 2, 2021. Accessed April 13, 2021.
  11. Transferrin saturation. Medscape website. http://emedicine.medscape.com/article/2087960-overview#a2. Accessed May 10, 2021.
  12. Staff hemoglobin test. Mayo Clinic website. https://www.mayoclinic.org/tests-procedures/hemoglobin-test/about/pac-20385075. Accessed May 11, 2021.
  13. Looker AC, Dallman PR, Carroll MD, Gunter EW, Johnson CL. Prevalence of iron deficiency in the United States. JAMA. 1997;277(12):973-976. doi:10.1001/jama.1997.03540360041028
  14. Serum iron test. MedlinePlus website. https://medlineplus.gov/ency/article/003488.htm. Accessed May 10, 2021.
  15. Pediatric Reference Ranges. Laboratory Services Handbook, Department of Pathology, The University of Iowa. Updated April 25, 2019. Accessed December 10, 2021.
    https://www. healthcare.uiowa.edu/path_handbook/Appendix/Heme/PEDIATRIC_NORMALS.html
  16. Appendix B: Pediatric Normal Laboratory Values. In: Andropoulos DB, Gregory GA, eds. Gregory’s Pediatric Anesthesia. 5th ed. Blackwell Publishing Ltd; 2012:1300-1315.
  17. Iron Panel (Iron, Transferrin, TIBC and % Saturation). Laboratory Services Handbook, Department of Pathology, The University of Iowa. Updated April 25, 2019. Accessed December 10, 2021.
    https://www.healthcare.uiowa.edu/path_handbook/handbook/test1151.html
  18. Miniero R, Talarico V, Galati MC, Giancotti L, Saracco P, Raiola G. Iron Deficiency and Iron Deficiency Anemia in Children. In: Rodrigo L, ed. Iron Deficiency Anemia. IntechOpen; 2019:23-39.
  19. Total iron binding capacity. MedlinePlus website. https://medlineplus.gov/ency/article/003489.htm. Accessed May 10, 2021.
  20. Kliger AS, Foley RN, Goldfarb DS, et al. KDOQI US commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD. Am J Kidney Dis. 2013;62(5):849-859.
  21. 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.
  22. 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.
  23. 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.
  24. Your guide to anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/sites/default/files/publications/11-7629.pdf. Published September 2011. Accessed April 13, 2021.
  25. 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.
  26. Klip IT, Comin-Colet J, Voors AA, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013;165(4):575-582.e3.
  27. Fishbane S, Pollack S, Feldman Hl, 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

    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 to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

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

    WARNINGS AND PRECAUTIONS

    Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

    Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

    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.

    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.

    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

    Adults

    In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

    The following 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 (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

    Pediatric

    The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

    CLINICAL CONSIDERATIONS IN PREGNANCY

    Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

    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.


    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.

    Please see Full Prescribing Information

IMPORTANT SAFETY INFORMATION

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 to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.

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.

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.

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

Adults

In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).

The following 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 (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

Pediatric

The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia, injection site reactions, rash, headache, and vomiting.

CLINICAL CONSIDERATIONS IN PREGNANCY

Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

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.


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.

Please see Full Prescribing Information

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