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)

#1

IV iron treatment by volume
among gastroenterologists1*†

Injectafer provides
the most iron per
course of treatment‡§

  • #1 IV iron treatment in worldwide sales1||
  • Over 1.7 million US patients treated
  • The most studied IV iron in the world1#
*Source: Symphony Health Solutions PHAST Non-Retail December 2019 - November 2020 (MAT Nov 2020). Source: IQVIA IV Iron Landscape (Dx and CDM Data - Jul-Oct 2020). Compared to the dosing regimens of other IV iron treatments.2-7 §One course of treatment is 2 doses of 750 mg separated by at least 7 days. ||Source: Vifor Pharma Group (Annual Report 2020). Source: Injectafer forecast model, Dec 20 demand. Jan 21 forecast. #Source: Trialtrove®, Mar 2021.

Injectafer for Gastroenterologists—Fully replenish your patient's iron deficit with Injectafer

When oral iron fails, it may be time to consider an IV iron

Choose Injectafer, the only FDA-approved IV iron that restores up to 1500 mg in 1 course of therapy. Injectafer is dosed in 2 administrations of 750 mg separated by at least 7 days.2 100% of IV iron is delivered into your patient's bloodstream.

Two Injectafer 750 mg IV Vials Artist's rendering.

1500 mg**†† in one course of treatment

Artist's rendering. Two Injectafer 750 mg IV Vials
15 Minutes Stopwatch 15 Minutes Stopwatch

IV infusion over at least 15 minutes

7.5 Minutes Stopwatch 7.5 Minutes Stopwatch

Slow IV push over 7.5 minutes

**For patients weighing less than 50 kg (110 lb), give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course of treatment. ††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.2

Injectafer treatment may be repeated if 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

Gastroenterology:

Underlying gastrointestinal (GI) conditions may put patients at risk for IDA 

Approximately 6.5 million adults in the United States have IDA1

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

Absorption is impaired in many patients with GI conditions, limiting the efficacy of oral iron therapy8,9

Condition IDA prevalence Oral iron challenge
IBD (Crohn‘s disease and ulcerative colitis) 36% to 76% of patients8 Impaired intestinal absorption due to associated inflammation10
 Bariatric surgery 33% to 49% of patients11 Impaired gastric capacity and absorption after surgery12
Celiac disease Approximately 46% of adult patients13‡‡
Impaired absorption due to villous atrophy of the intestinal mucosa14
‡‡Study conducted in Italy and included only Italian subjects.

GI bleeding is found in approximately 50% of patients with IDA.15 GI bleeding can be caused by conditions such as16

Diagram displaying GI bleeding can be caused by conditions such as Peptic ulcers and Colon cancer
Diagram displaying GI bleeding can be caused by conditions such as Peptic ulcers and Colon cancer
clinical consideration

Clinical Consideration

Some common GI medications, such as proton pump inhibitors, antacids, and H2 blockers, reduce stomach acid, which may interfere with absorption of oral iron.15

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.

 

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 for adults 18 years or older who are commercially insured. Please see full Terms and Conditions above. IIIIInsurance 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]. Shirley, NY: American Regent, Inc.; November 2021.
  3. Venofer® (iron sucrose) injection, USP [package insert]. Shirley, NY: American Regent, Inc.; 2020.
  4. Ferrlecit® (sodium ferric gluconate complex in sucrose injection) [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; 2020.
  5. INFeD® (Iron Dextran Injection USP) [package insert]. Parsippany, NJ: Allergan, Inc; 2020.
  6. Feraheme® (ferumoxytol injection) [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc; 2020.
  7. Monoferric® (ferric derisomaltose) [package insert]. Holbaek, Denmark: Pharmacosmos A/S; 2020.
  8. 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.
  9. Cançado RD, Muñoz M. Intravenous iron therapy: how far have we come? Rev Bras Hematol Hemoter. 2011;33(6):461-469.
  10. Reinisch W, Staun M, Bhandari S, Muñoz M. State of the iron: how to diagnose and efficiently treat iron deficiency anemia in inflammatory bowel disease. J Crohn's Colitis. 2013;7(6):429-440.
  11. Knight T, D’Sylva L, Moore B, Barish CF. Burden of iron deficiency anemia in bariatric surgery population in the United States. J Manag Care Spec Pharm. 2015;21(10):946-954.
  12. Ruz M, Carrasco F, Rojas P, et al. Iron absorption and iron status are reduced after Roux-en-Y gastric bypass. Am J Clin Nutr. 2009;90(3):527-532.
  13. Bottaro G, Cataldo F, Rotolo N, Spina M, Corazza GR. The clinical pattern of subclinical/silent celiac disease: an analysis on 1026 consecutive cases. Am J Gastroenterol. 1999;94(3):691-696.
  14. Fernàndez-Bañares F, Monzón H, Forné M. A short review of malabsorption and anemia. World J Gastroenterol. 2009;15(37):4644-4652.
  15. Zhu A, Kaneshiro M, Kaunitz JD. Evaluation and treatment of iron deficiency anemia: a gastroenterological perspective. Dig Dis Sci. 2010;55(3):548-559.
  16. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed April 29, 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 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.


    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.


Please see Full Prescribing Information

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