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.

The first & only FDA-approved IV iron to treat iron deficiency in adult patients with heart failure1-6

(With New York Heart Association class II/III, to improve exercise capacity)

Injectafer improves ID
for appropriate patients with HF1

Choose Injectafer
To provide the most iron per course of treatment in IDA1-6*† & for appropriate patients with iron deficiency (ID) and heart failure (HF)1‡

  • Approved for first-line use in your patients with ID and HF1
  • Improves exercise capacity for patients with ID and HF7
*Compared to the dosing regimens of other intravenous (IV) iron treatments.1-6 For iron deficiency anemia (IDA), one course of treatment is 2 doses of 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.7 Injectafer is an iron replacement product indicated for the treatment of ID in adult patients with HF and New York Heart Association (NYHA) class II/III to improve exercise capacity.7

Connect with a Representative for more information

Injectafer for Cardiologists—consider Injectafer as a first-line treatment for your adult patients with ID and HF. Injectafer is the first and only FDA-approved IV iron to treat ID in adult patients with HF and NYHA class II/III to improve exercise capacity.1-6

Examine the 4 Ds of Injectafer

Data

Injectafer is the most-studied IV iron treatment with more than 40 clinical trials and >8800 patients treated worldwide

Dose

Injectafer may replenish your patients’ iron deficit1,9

  • provides the most iron per course of treatment—1500 mg—in IDA1-6||
  • provides weight-based dosing and offers maintenance dosing beyond 6 weeks for patients with ID and HF1

Delivery

Injectafer is the only high-dose IV iron that can be administered intravenously through infusion or as an undiluted slow IV push1-6

Dilution

Injectafer can be given up to 250 mL diluted for IV infusion or as a slow IV push (refer to the Full Prescribing Information for details)1

Injectafer treatment may be repeated if IDA or ID in HF reoccurs. Check serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment or for any patient who receives a repeat course of treatment within three months. Treat hypophosphatemia as medically indicated.1

§Source: Trialtrove., Mar 2021.8 ||Compared to the dosing regimens of other IV iron treatments.1-6

Cardiology:

~50% of all patients with HF have ID10

~50% of NYHA class II and III have ID and IDA11

Over 6.5 million adults in the United States have IDA8

Review the HF and ID pivotal study for Injectafer

30% to 50% of patients with chronic HF also have ID12

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

**Injectafer is not indicated for the treatment of ID.1

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, 8:00 AM–6:00 PM ET.

savings

Financial Assistance Programs

Injectafer Savings Program


††Injectafer Savings Program is only available for patients aged 1 year or older who are commercially insured. Please see full Terms and Conditions at DSIAccessCentral.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. 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.
  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; 2023.
  2. Venofer®. Package insert. American Regent, Inc; 2022.
  3. Ferrlecit®. Package insert. sanofi-aventis U.S. LLC; 2022.
  4. INFeD®. Package insert. Allergan USA, Inc; 2021.
  5. Feraheme®. Package insert. AMAG Pharmaceuticals, Inc; 2022.
  6. Monoferric®. Package insert. Pharmacosmos Therapeutics Inc; 2022.
  7. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/ HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(17):e263-e421. doi:10.1016/j. jacc.2021.12.012
  8. Data on file. Daiichi Sankyo Inc., Basking Ridge, NJ.
  9. Koch TA, Myers J, Goodnough LT. Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations. Anemia. 2015. doi:10.1155/2015/763576
  10. 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
  11. 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.
  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.(cont'd)
  19. Heart failure. MedlinePlus website. https://medlineplus.gov/ency/article/000158.htm.Updated April 2, 2021. 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