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.

NOW APPROVED! The first & only IV iron to treat iron deficiency in adult patients with heart failure1-7

Injectafer improves outcomes
for patients with heart failure2

Injectafer is the first and only FDA-approved IV iron to treat iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity 2-7

  • Approved for first-line use in your patients with iron deficiency (ID) and heart failure (HF) 2
  • Improves exercise capacity for patients with ID and HF 8

Connect with a Representative for more information

Injectafer for Cardiologists — Consider Injectafer as a first-line treatment for your adult patients with HF and ID. Injectafer is the first and only FDA-approved IV iron to treat ID in adult patients with HF and New York Heart Association (NYHA) class II/III to improve exercise2-7

Examine the 4 Ds of Injectafer

Data

  • Injectafer is the first and only FDA-approved IV iron to demonstrate improvements in 2 key areas2-7
  • Exercise capacity: improved 6MWT (change from baseline and placebo) at 24 weeks by 25 m2
  • Iron parameters: improved ferritin, TSAT, and Hb (change from baseline and placebo) by 269 ng/mL, 9%, and 0.6 g/dL, respectively, at Week 242

Dosing

Injectafer provides weight-based dosing and offers maintenance dosing beyond 6 weeks2

Delivery

The only high dose IV iron that can be administered as an undiluted slow intravenous push or intravenous infusion2-7

Dilution

Injectafer can be given up to 250 mL diluted for IV administration or as little as 15 mL undiluted for IV push2

Injectafer treatment may be repeated if iron deficiency (ID) or iron deficiency anemia (IDA) reoccurs. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.2

Cardiology:

~50% of all patients with HF have iron deficiency9

~50% of NYHA class II and III have ID and IDA10

ID in HF is associated with 40-60% increase in the risk of mortality and a 2X increase in the risk of hospitalization11*

*Injectafer is not indicated to treat the risk of mortality or the risk of hospitalization in patients with heart failure and NYHA class II/III.2

Over 6.5 million adults in the United States have IDA1

Review the heart failure and iron deficiency pivotal study for Injectafer

30% to 50% of patients with chronic heart failure (HF) also have iron deficiency12

Consider routinely testing your patients with HF for ID

Signs and symptoms of ID and HF can be similar due to impaired oxygen delivery
Anemia13-17 HF17-19
Dyspnea Dyspnea
Edema Edema
Fatigue Fatigue
Cognitive impairment Confusion
Angina pectoris Angina pectoris

The incidence of iron deficiency and anemia were greater among patients in a more severe New York Heart Association (NYHA) functional class10††

Results seen in a study of an international pooled cohort comprising 1506 patients with HF10††

Graph displaying the incidence of iron deficiency and anemia were greater among patients in a more severe New York Heart association functional class
chart
CHF, chronic heart failure.

**Injectafer is not indicated for the treatment of iron deficiency.2

††Data were captured from a single measurement in time, and the effects of changes in iron, anemia, or NYHA functional class status over time should not be inferred.10

‡‡Patients with both iron deficiency and anemia were older and had a higher NYHA functional class, more comorbidities, and higher biomarker levels compared with those with iron deficiency and no anemia.10

§§NYHA IV functional class is defined as being unable to perform any physical activity without discomfort and having symptoms of CHF present at rest.20

injectconnect Support Program

injectconnect


Daiichi Sankyo Access Central offers a suite of support programs to help appropriate patients access Injectafer therapy, including claims & appeals support and financial assistance programs.

Visit DSIAccessCentral.com to download helpful resources. You can also connect live with an Access Central Coordinator by calling 1-866-4-DSI-NOW, Monday–Friday, 9:00 AM–8:00 PM ET.

savings

Financial Assistance Programs

Injectafer Savings Program


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 insured patients may pay no more than $50 per dose for two courses of treatment per 12-month period and up to a maximum savings limit of $500 per dose, a $1,000 program limit per course of treatment. Check with your pharmacist or healthcare provider for your copay discount. Patient out-of-pocket expense may vary.
  3. This offer is not valid for patients enrolled in Medicare, 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. This offer is valid for 2 courses or 4 doses of the 750-mg dose of the Injectafer prescription. An explanation of benefits statement must be faxed, uploaded in the portal or mailed in prior to transacting on the account numbers for co-pay assistance. One enrollment is allowed per 12-month period.
  5. Daiichi Sankyo, 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.
  6. Void if prohibited by law, taxed, or restricted.
  7. This account number is not transferable. The selling, purchasing, trading, or counterfeiting of this account number is prohibited by law.
  8. This account number is not insurance.
  9. 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.
  10. Qualified patients receiving Injectafer will be allowed a 120-day retroactive enrollment period to receive benefits under the program rules.
||||The Injectafer Savings Program is only available to patients aged 1 year or older who are commercially insured. Please see full Terms and Conditions above. ¶¶Insurance out-of-pocket payment must be over $50. Other restrictions may apply.

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. Data on file. Daiichi Sankyo Inc., Basking Ridge, NJ.
  2. Injectafer®. Package insert. American Regent, Inc.; 2023.
  3. Venofer®. Package insert. American Regent, Inc.; 2020.
  4. Ferrlecit®. Package insert. sanofi-aventis US LLC; 2020.
  5. INFeD®. Package insert. Allergan, Inc; 2020.
  6. Feraheme®. Package insert. AMAG Pharmaceuticals, Inc; 2020.
  7. Monoferric®. Package insert. Pharmacosmos A/S; 2020.
  8. 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
  9. Ebner N, von Haehling S. Why is iron deficiency recognised as an important comorbidity in heart failure? Card Fail Rev. 2019;5(3):173-175. doi:10.15420/cfr.2019.9.2
  10. 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.
  11. Lam CSP, Doehner W, Comin-Colet J, IRON CORE Group. Iron deficiency in chronic heart failure: case-based practical guidance. ESC Heart Fail. 2018;5(5):764-771. doi:10.1002/ehf2.12333
  12. Rocha BML, Cunha GJL, Menezes Falcão LF. The burden of iron deficiency in heart failure: therapeutic approach. J Am Coll Cardiol. 2018;71(7):782-793.
  13. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed April 13, 2021.
  14. 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.
  15. Iron-deficiency anemia. American Society of Hematology website. https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed April 13, 2021.
  16. Friedman AJ, Chen Z, Ford P, et al. Iron deficiency anemia in women across the life span. J Womens Health (Larchmt). 2012;21(12):1282-1289.
  17. Top Doctors®, United Kingdom. Iron Deficiency. Accessed June 29, 2022. https://www.topdoctors.co.uk/medical-dictionary/iron- deficiency#
  18. Dumitru I. Heart failure clinical presentation. Medscape website. http://emedicine.medscape.com/article/163062-clinical. Updated March 2, 2021. Accessed April 13, 2021.
  19. Heart failure. MedlinePlus website. https://medlineplus.gov/ency/article/000158.htm. Updated April 2, 2021. Accessed April 13, 2021.
  20. New York Heart Association (NYHA) classification. Heart Online website. https://heartonline.org.au/media/DRL/New_York_Heart_Association_(NYHA)_classification.pdf. Accessed April 13, 2021.
  • 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 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.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

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

    WARNINGS AND PRECAUTIONS

    Symptomatic Hypophosphatemia

    Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible 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, and malnutrition. In most cases, hypophosphatemia resolved within three months.

    Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. 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 second course of therapy within three months. Treat hypophosphatemia as medically indicated.

    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

    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%).

    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 (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).

    Patients with Iron Deficiency and Heart Failure

    The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.

    Post-Marketing Experience

    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; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

    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.


    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 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Symptomatic Hypophosphatemia

Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible 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, and malnutrition. In most cases, hypophosphatemia resolved within three months.

Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. 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 second course of therapy within three months. Treat hypophosphatemia as medically indicated.

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

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%).

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 (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).

Patients with Iron Deficiency and Heart Failure

The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.

Post-Marketing Experience

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; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.

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.


Please see Full Prescribing Information

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