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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Telehealth Resource Center

Share this information during your virtual visits with patients to help discuss iron deficiency anemia (IDA) and Injectafer® (ferric carboxymaltose injection).
  • WHAT IS IDA?
  • IDA SYMPTOMS
  • IDA LAB MARKERS
  • IDA TREATMENT OPTIONS
  • PREPARING FOR INFUSIONS
  • SAVINGS & SUPPORT

What is IDA?

IDA is the most common type of anemia1

commonAnemia1

Iron helps produce hemoglobin, a part of red blood cells, which is a molecule that carries oxygen in your blood.1

commonAnemia2

Without enough iron, your body starts using the iron it has stored. Soon, the stored iron gets used up.1

commonAnemia3

Without iron, your body cannot produce the number of normal red blood cells needed to keep you in good health.2

What causes IDA?

  • Low iron levels (iron deficiency) cause IDA1
  • IDA occurs when iron in your body becomes depleted or you aren’t adequately replenishing what your body uses1
  • Your iron deficiency is the difference between the amount of iron you have and the amount you need to keep you in good health3,4
  • If your iron deficiency progresses, you may have IDA4

IDA can coexist with many different diseases or conditions

  • IDA and gastrointestinal conditions

    Gastrointestinal conditions4

  • women

    Women’s health conditions4

  • IDA and cancer

    Cancer4

  • IDA and non-dialysis dependent chronic kidney disease

    Chronic kidney disease5

  • heart fail

    Heart failure6

  • Blood Loss

    Blood loss from injury or surgery7

References:

  1. Anemia. American Society of Hematology. https://www.hematology.org/education/patients/anemia. Accessed May 11, 2021.
  2. Anemia. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/anemia/symptoms-causes/syc-20351360.
    Accessed May 11, 2021.
  3. Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; February 2022.
  4. Bermejo F, García-López S. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive disease. World J Gastroenterol. 2009;15(37):4638-4643.
  5. Anemia in chronic kidney disease. National Institute of Diabetes and Digestive and Kidney Diseases website.
    https://www.niddk.nih.gov/health-information/kidney-disease/anemia. Accessed May 11, 2021.
  6. Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011;58(12):1241-1251.
  7. Iron-deficiency anemia. American Society of Hematology website.
    https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed May 11, 2021.

IDA symptoms

The symptoms of IDA are often nonspecific and may be underreported. Some people may not experience any symptoms1

The signs and symptoms of IDA can overlap with those of other conditions. If you are experiencing any of these symptoms, it’s important to discuss them with your doctor.1-4

Some of the symptoms of IDA5*:

  • 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
  • Irregular heartbeat
  • Dizziness or lightheadedness
  • Brittle nails
  • Coldness in extremities
  • Pica (craving nonfood items such as dirt or ice)

*Injectafer has not been studied or approved for treating symptoms of IDA.6

References:

  1. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website.
    https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed May 11, 2021.
  2. 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.
  3. Dumitru I. Heart failure clinical presentation. Medscape website. http://emedicine.medscape.com/article/163062-clinical. Updated March 2, 2021. Accessed May 11, 2021.
  4. Colorectal cancer symptoms. Cancer Treatment Centers of America® website.
    https://www.cancercenter.com/cancer-types/colorectal-cancer/symptoms. Accessed May 11, 2021.
  5. Iron deficiency anemia. Mayo Clinic website.
    https://www.mayoclinic.org/diseases-conditions/iron-deficiency-anemia/symptoms-causes/syc-20355034. Accessed April 13, 2021.
  6. Injectafer [package insert]. Shirley, NY: American Regent, Inc.; February 2022. 

IDA lab markers

Common lab markers for monitoring IDA and normal iron levels in adults

microscope

Your lab results are the results of your blood test. They are used to diagnose iron deficiency anemia (IDA) and monitor and manage your condition during treatment.

Chart
Chart
Hb, hemoglobin; TSAT, transferrin saturation.

An additional test for total iron binding capacity (TIBC) may be required to diagnose IDA. Normal values for TIBC range from 240 to 450 μg/dL in healthy patients.6,7 Please note TIBC values were not measured in Injectafer clinical trials.

*Injectafer has not been studied or approved for treating people with chronic kidney disease (CKD) who are on dialysis or people 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. Please consult the NKF guidelines for a complete list of recommendations for IDA lab values when starting treatment.8,9

References:

  1. 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.
  2. Kaitha S, Bashir M, Ali T. Iron deficiency anemia in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2015;6(3):62-72.
  3. Staff hemoglobin test. Mayo Clinic website.
    https://www.mayoclinic.org/tests-procedures/hemoglobin-test/about/pac-20385075. Accessed May 11, 2021.
  4. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website. https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed May 11, 2021.
  5. Serum iron test. MedlinePlus website. https://medlineplus.gov/ency/article/003488.htm. Accessed April 13, 2021.
  6. Iron-deficiency anemia. American Society of Hematology website. https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed May 11, 2021.
  7. Total iron binding capacity. MedlinePlus website. https://medlineplus.gov/ency/article/003489.htm. Accessed May 11, 2021.
  8. 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.
  9. Injectafer [package insert]. Shirley, NY: American Regent, Inc.; February 2022.

IDA treatment options

  • About
    oral iron

    Learn more

  • About
    IV iron

    Learn more

Your doctor will most likely prescribe an oral iron treatment for you first.

For some people with IDA, iron pills may not be the right option. There are several reasons why this might be. The most common reasons are1,2:

  • Iron in oral form can cause hard-to-tolerate side effects
  • Oral iron can fail to replenish iron levels to where the body needs them because the digestive system has trouble absorbing it
health

EVEN IN HEALTHY PATIENTS, LESS THAN 10% OF ORAL IRON IS ABSORBED3*

*Less than 10% absorption of oral iron is based on a regimen of 300-mg or 320-mg tablets 3 to 4 times a day.4

Patients with IDA may require IV iron therapy. This kind of treatment is done in an infusion center.

Some of the reasons your doctor may prescribe IV iron to treat your IDA could include:

  • Oral iron is not absorbing well in the digestive system
  • Blood loss—which can be caused by a number of things including, but not limited to, heavy periods, major surgery or physical trauma, and some gastrointestinal diseases

WITH IV IRON,

100

  • About
    oral iron

    Learn more

    Your doctor will most likely prescribe an oral iron treatment for you first.

    For some people with IDA, iron pills may not be the right option. There are several reasons why this might be. The most common reasons are1,2:

    • Iron in oral form can cause hard-to-tolerate side effects
    • Oral iron can fail to replenish iron levels to where the body needs them because the digestive system has trouble absorbing it
    Less than 10% of oral iron is absorbed

    EVEN IN HEALTHY PATIENTS, LESS THAN 10% OF ORAL IRON IS ABSORBED3*

    *Less than 10% absorption of oral iron is based on a regimen of 300-mg or 320-mg tablets 3 to 4 times a day.4

  • About
    IV iron

    Learn more

    Patients with IDA may require IV iron therapy. This kind of treatment is done in an infusion center.

    Some of the reasons your doctor may prescribe IV iron to treat your IDA could include:

    • Oral iron is not absorbing well in the digestive system
    • Blood loss—which can be caused by a number of things including, but not limited to, heavy periods, major surgery or physical trauma, and some gastrointestinal diseases

    WITH IV IRON,

    With IV Iron 100% is delivered into the bloodstream

    Delivered into the bloodstream

Injectafer: An IV iron

  • Injectafer is used to treat adults and pediatric patients 1 year of age and older with iron deficiency anemia5:
    • When oral iron treatments haven't worked, or side effects from oral iron couldn't be tolerated, or
    • For adults with non-dialysis dependent chronic kidney disease
  • Unlike with pills, 100% of the iron in Injectafer goes directly into the bloodstream5
  • Proven in clinical studies in more than 8800 patients, Injectafer demonstrated greater increases in hemoglobin at follow-up than either oral iron or another intravenous (IV) iron6,7

Injectafer provides the most iron per course of treatment—up to 1500 mg in 2 doses of 750 mg separated by at least 7 days.5,8-12† Injectafer is also available as a 100 mg iron/2 mL single-dose vial.5

Two Injectafer 750 mg IV Vials Artist's rendering.

1500 mgठin one course of treatment

Artist's rendering. Two Injectafer 750 mg IV Vials
IV infusion over at least 15 minutes IV infusion over at least 15 minutes

IV infusion over at least 15 minutes

Slow IV push over 7.5 minutes Slow IV push over 7.5 minutes

Slow IV push over 7.5 minutes

Injectafer treatment may be repeated if IDA reoccurs. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.5

†Compared to the dosing regimens of other IV iron treatments.5,8-12 ‡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.1

§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.5

  • Potential side effects with Injectafer include, but are not limited to, allergic reactions, nausea, temporary hypertension, and flushing5

    If you weigh less than 110 pounds, you may be given a smaller amount of Injectafer. Your doctor will decide on the most appropriate way to give you your treatment5:
  • Each Injectafer infusion takes about 15 minutes. After your infusion, your healthcare provider will monitor you for signs and symptoms of an allergic reaction—usually for about 30 minutes
  • If you are at risk for low serum phosphate, your doctor may monitor your serum phosphate levels if you require a second course of treatment of Injectafer (beyond 2 administrations of up to 750 mg each). Your doctor can discuss risk factors for low serum phosphate with you

Over 2 million people have been treated with Injectafer in the United States alone.7 II

Not an actual patient.
patient-lady
IISource: Injectafer forecast model, Jan 22 demand, Feb 22 forecast.
patient brochure icon

Download helpful information and track your progress with the Injectafer patient brochure

Download Brochure

If you take Injectafer, follow up with your doctor after your infusion(s) to see how Injectafer works for you.

References:

  1. Iron-deficiency anemia. American Society of Hematology website.
    https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed May 11, 2021.
  2. Iron-deficiency anemia. National Heart, Lung, and Blood Institute website.
    https://www.nhlbi.nih.gov/health-topics/iron-deficiency-anemia. Accessed May 11, 2021.
  3. Zhu A, Kaneshiro M, Kaunitz JD. Evaluation and treatment of iron deficiency anemia: a gastroenterological perspective. Dig Dis Sci. 2010;55(3):548-559.
  4. Fernández-Bañares F, Monzón H, Forné M. A short review of malabsorption and anemia. World J Gastroenterol. 2009;15(37):4644-4652.
  5. Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; February 2022.
  6. 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.
  7. Data on file. Daiichi Sankyo Inc., Basking Ridge, NJ.
  8. Venofer® (iron sucrose) injection, USP [package insert]. Shirley, NY: American Regent, Inc.; 2020.
  9. Ferrlecit® (sodium ferric gluconate complex in sucrose injection) [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; 2020.
  10. INFeD® (Iron Dextran Injection USP) [package insert]. Parsippany, NJ: Allergan, Inc; 2020.
  11. Feraheme® (ferumoxytol injection) [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc; 2020.
  12. Monoferric® (ferric derisomaltose) [package insert]. Holbaek, Denmark: Pharmacosmos A/S; 2020.

Preparing for Injectafer infusions

Injectafer is given by IV infusion, usually at an infusion center, where a healthcare professional can administer it directly into the bloodstream through a vein. Infusion centers are medical facilities equipped and staffed for administering infusions.1

location icon

Find an infusion center that provides Injectafer by using the Injectafer Infusion Center Locator

Find an infusion center

How long do Injectafer infusions take?

stopwatch
  • Each Injectafer infusion may take about 15 minutes2
  • Afterward, your healthcare provider will monitor you for about 30 minutes for signs of allergic reaction2

  • Before your first Injectafer infusion

    • Call ahead to confirm that the infusion center can provide Injectafer IV iron
    • Ask about Injectafer by name. Injectafer is the only FDA-approved IV iron that can provide up to 1500 mg of iron in just 2 doses of 750 mg separated by at least 7 days2
    • Dress comfortably and eat as you normally would. There are no special dietary requirements
    • Bring insurance coverage identification and any other information your doctor has asked you to bring

  • During your infusion

    • The usual dosage is 1500 mg, administered in 2 separate doses of 750 mg each separated by at least 7 days. Your dosage may vary based on your weight2
    • Your infusion may take about 15 minutes, and your doctor or nurse will monitor your response during and after your infusion2

  • After each infusion

    • Your iron stores are replenished over time, so it’s important for you to follow up with your doctor and retest your levels3
    • In some patients, an increase in blood pressure with dizziness, nausea, or flushing of the face may occur right after a dose of Injectafer. It usually goes away within 30 minutes. Tell your doctor right away if symptoms persist or worsen2
    • Be sure to follow up with your physician to see how Injectafer is working for you
patient brochure icon

Download helpful information and track your progress with the Injectafer patient brochure

Download Brochure

References:

  1. National Infusion Center Association. Infusion therapy: frequently asked questions. https://infusioncenter.org/faqs. Accessed May 11, 2021.
  2. Injectafer® [package insert]. Shirley, NY: American Regent, Inc.; February 2022. 
  3. Nall R. Iron infusion: uses, benefits, and what to expect. Medical News Today website.
    https://www.medicalnewstoday.com/articles/318827.php. Accessed May 11, 2021.

Injectafer savings & support

injectconnect
injectconnect

Two financial assistance programs for eligible Injectafer patients*

*Restrictions apply.
1

If Injectafer is covered by your commercial insurance, but you have a copay

icon_hand 

Injectafer Savings Program

For eligible patients

  • Assistance of up to $500 per dose
  • Enrollment is valid for 2 courses of treatment per 12-month period

Financial Assistance†

PATIENTS RECEIVE EACH
DOSE FOR AS LITTLE AS

$50‡
†The Injectafer Savings Program is only available for adults 18 years or older who are commercially insured. Please see full Terms and Conditions below. ‡Insurance out-of-pocket payment must be over $50. Other restrictions may apply.

Download the Patient Savings Program Brochure for more information and see the eligibility requirements below.

Download the Patient Savings Program Brochure
2

If you do not have insurance to cover treatment or are commercially underinsured

icon_lady 

Patient Assistance Program

The Patient Assistance Program was created to help patients who lack health insurance or are commercially underinsured and cannot afford therapy.

Call Daiichi Sankyo Access Central at 1-866-437-4669 to find out if you are eligible.

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, and a $1,000 program limit per course of treatment. 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, 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 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 copay 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.

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.

  • 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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