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Frequently Asked Questions
Proper billing and coding can help ensure appropriate patients receive timely treatment. The following codes may be helpful to facilitate Injectafer reimbursement. The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider.
Billing and Coding
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Product and administration codes
Code Type Code Description Product Package Code NDC 00517-0650-01 Injectafer 750 mg iron/15 mL single-dose vial (individually boxed) NDC 0517-0602-01 Injectafer 100 mg iron/2 mL single-dose vial (individually boxed) Product-Specific Billing Code HCPCS† J1439 Injection, ferric carboxymaltose 1 mg Drug Administration Codes CPT®* 96374 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug or 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour *CPT® codes, 2019 American Medical Association (AMA). All rights reserved. CPT is a trademark of the AMA. No fee schedules, basic units, relative values, or related listings are included in the CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.
†Use this unique J code for Injectafer when billing for claims to insurance.
Abbreviations: CPT, Current Procedural Terminology; FARS/DFARS, Federal Acquisition Regulation/Defense Federal Acquisition Regulation Supplement; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code. -
Examples of IDA- and ID-related diagnosis codes
Injectafer claims forms require an appropriate ICD-10-CM code. The following table displays possible ICD-10-CM codes related to iron deficiency anemia (IDA) and iron deficiency (ID).1
Code Description D50.0 Iron deficiency anemia secondary to blood loss (chronic) K90.0 Celiac disease E61.1 Iron Deficiency (excludes iron deficiency anemia (D50.0)) D50.1 Sideropenic dysphagia D50.8 Other iron deficiency anemias D50.9 Iron deficiency anemia, unspecified D63.0 Anemia in neoplastic disease CODE NEOPLASM FIRST (Confirm iron deficiency) D63.1 Anemia in chronic kidney disease CODE CKD STAGE FIRST (Confirm iron deficiency) D63.8 Anemia in other chronic diseases classified elsewhere CODE UNDERLYING DISEASE FIRST (Confirm iron deficiency) D63.81 Antineoplastic chemotherapy-induced anemia (Confirm iron deficiency) Other codes may be appropriate.
Coding for Injectafer is dependent on the insurer and the care setting in which the drug will be administered. THESE TABLES ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY, AND YOU HAVE THE RESPONSIBILITY TO ENSURE THAT CLAIMS AND CODES SUBMITTED ARE ACCURATE, COMPLETE, and APPLICABLE. Healthcare providers need to make coding decisions based on the diagnosis and treatment of each patient and the specific insurer. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes.
†A joint effort between the healthcare provider and the coder is essential to achieve complete and accurate documentation, code assignment, and reporting of diagnoses and procedures. This information is provided to assist both the healthcare provider and the coder in identifying POTENTIAL diagnoses. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation, accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated. Abbreviation: ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification. -
A code specific to your HF and IDA patients*
The following table displays possible secondary ICD-10-CM codes that may be appropriate for patients prescribed Injectafer.‡
Code Description K50.0-K50.919 Crohn‘s disease (regional enteritis) K51.0-K51.919 Ulcerative colitis K90.4 Malabsorption due to intolerance not elsewhere classified K90.9 Intestinal malabsorption, unspecified N18.1 Chronic kidney disease, stage 1 N18.2 Chronic kidney disease, stage 2 N18.30 Chronic kidney disease, stage 3 unspecified N18.31 Chronic kidney disease, stage 3a N18.32 Chronic kidney disease, stage 3b We recommend verifying the coding policies for each individual health plan. Reimbursement specialists can provide information relating to payer-specific policies and can address other questions at 1-866-4-DSI-NOW. The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Daiichi Sankyo, Inc., makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided. ‡Secondary code suggestions only; appropriate codes not limited to those listed above. Injectafer is indicated to treat IDA; it is not indicated to treat the above listed underlying conditions. Some listed diagnosis codes may indicate a subcategory and be nonbillable. For reporting purposes, only codes with the full number of required characters are permissible. A joint effort between the healthcare provider and the coder is essential to achieve complete and accurate documentation, code assignment, and reporting of diagnoses and procedures. This information is provided to assist both the healthcare provider and the coder in identifying POTENTIAL diagnoses. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation, accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.Code Description N18.4 Chronic kidney disease, stage 4 N18.5 Chronic kidney disease, stage 5 N18.6 End-stage renal disease N18.9 Chronic kidney disease, unspecified N92.0 Excessive and frequent menstruation with regular cycle N92.5 Other specified irregular menstruation N92.6 Irregular menstruation, unspecified T45.4X5A Adverse effect of iron and its compounds, initial encounter T50.905A Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter -
A code specific for your HF with IDA patient's underlying condition*
The following table displays possible secondary ICD-10-CM codes that may be appropriate for patients prescribed Injectafer.†
Code Description I09.81 Rheumatic Heart Failure I11.0 Hypertensive Heart Disease with Heart Failure I50 Heart Failure I50.1 Left Ventricular Failure, Unspecified I50.2 Systolic (Congestive) Heart Failure I50.20 Unspecified Systolic (Congestive) Heart Failure I50.21 Acute Systolic (Congestive) Heart Failure I50.22 Chronic Systolic (Congestive) Heart Failure I50.23 Acute on Chronic Systolic (Congestive) Heart Failure I50.3 Diastolic (Congestive) Heart Failure I50.30 Unspecified Diastolic (Congestive) Heart Failure I50.31 Acute Diastolic (Congestive) Heart Failure I50.32 Chronic Diastolic (Congestive) Heart Failure I50.33 Acute on Chronic Diastolic (Congestive) Heart Failure I50.4 Combined Systolic and Diastolic (Congestive) Heart Failure Code Description I50.40 Unspecified Combined Systolic and Diastolic (Congestive) Heart Failure I50.41 Acute Combined Systolic and Diastolic (Congestive) Heart Failure I50.42 Chronic Combined Systolic and Diastolic Heart Failure I50.43 Acute on Chronic Combined Systolic and Diastolic Heart Failure I50.8 Other Heart Failure I50.81 Right Heart Failure I50.810 Right Heart Failure, Unspecified I50.811 Acute Right Heart Failure I50.812 Chronic Right Heart Failure I50.813 Acute on Chronic Right Heart Failure I50.814 Right Heart Failure Due to Left Heart Failure I50.82 Biventricular Heart Failure I50.83 High Output Heart Failure I50.84 End Stage Heart Failure I50.89 Other Heart Failure I50.9 Heart Failure, Unspecified
For help with reimbursement, contact Daiichi Sankyo Access Central at 1-866-4-DSI-NOW (1-866-437-4669), Monday–Friday,II 8:00 AM–6:00 PM ET. Click here to learn more.
https://injectaferhcp-cm.preprod.ds-sc.com/iron-injection-administrationSecondary code suggestions only; appropriate codes not limited to those listed above. Injectafer is indicated to treat IDA; it is not indicated to treat the above-listed underlying conditions. Some listed diagnosis codes may indicate a subcategory and be nonbillable. For reporting purposes, only codes with the full number of required characters are permissible.
†A joint effort between the healthcare provider and the coder is essential to achieve complete and accurate documentation, code assignment, and reporting of diagnoses and procedures. This information is provided to assist both the healthcare provider and the coder in identifying potential diagnoses. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation, accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.
Abbreviation: HF, heart failure.
IIExcludes holidays.
Frequently Asked Questions About Injectafer® (ferric carboxymaltose injection) IV Iron Infusions
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Which patients can receive Injectafer intravenous (IV) iron?
Injectafer is indicated for the treatment of 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(NDD-CKD). Injectafer is also indicated for ID in adult patients with heart failure (HF) and New York Heart Association (NYHA) class II/III to improve exercise capacity.
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What size infusion bag is needed?Dilute Injectafer in up to 250 mL (but not more) of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL.1 If you need further guidance, contact your Injectafer Territory Manager to arrange a consultation with an Oncology Clinical Educator.
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What size needle do I use?The infusion nurse or administering healthcare professional should assess the patient’s vein status and choose an appropriate gauge needle. If you need further guidance, contact your Injectafer Territory Manager to arrange a consultation with an Oncology Clinical Educator.
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Do I need filtered tubing?Filtered tubing is not necessary. If you need further guidance, contact your Injectafer Territory Manager to arrange a consultation with an Oncology Clinical Educator.
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How do I mix Injectafer?
Dilute up to 750 mg of Injectafer in up to 250 mL (but not more) of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL. Administer over at least 15 minutes.1
At concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.1
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.1
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What is the dosing for patients who weigh 50 kg or more?For patients weighing 50 kg (110 lb) or more: Give Injectafer in 2 doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose of 1500 mg of iron per course.1
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What is the dosing for patients who weigh less than 50 kg?For patients weighing less than 50 kg (110 lb): Give Injectafer in 2 doses separated by at least 7 days. Give each dose as 15 mg/kg body weight.1
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Can Injectafer be administered by IV push instead of infusion?Yes. Injectafer may be administered as an undiluted slow IV push. Give at the rate of approximately 100 mg (2 mL) per minute.1
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Are there any special precautions to keep in mind when administering Injectafer?Injectafer should only be administered when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.1
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How often can patients be retreated with Injectafer?Injectafer treatment may be repeated if IDA reoccurs, based on the clinical judgment of the healthcare provider. Note that in the 24 hrs following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer. Injectafer doses must be separated by at least 7 days.1
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How should Injectafer be stored prior to use?Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.1
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What should I do if extravasation occurs?Monitor for extravasation, and if it occurs, discontinue the Injectafer administration at that site immediately.1
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What are the most common side effects of Injectafer?
- The most common side effects of Injectafer in the pivotal trials (reported by ≥2% of study patients) were: nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); dizziness (2.1%); and vomiting (2%)
- In pivotal trials 1 and 2 for Injectafer, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer
- Pivotal trials for Injectafer included patients with a history of oral iron intolerance, drug allergies (with the exception of known hypersensitivity to study treatments), and hypotension2,3
Review the most common adverse events reported during pivotal trials.
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What reimbursement support and patient access options are available?
For eligible patients, Injectafer is covered under the medical benefit of most health insurance plans.For information on reimbursement and patient support options, call Daiichi Sankyo Access Central at 1-866-4-DSI-NOW, Monday–Friday, 8:00 AM–6:00 PM ET or visit dsiaccesscentral.com/hcp/injectafer.
References:
- Injectafer®. Package insert. American Regent, Inc.; 2025.
- 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.
- Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014;29(4):833-842.
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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, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). 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.
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.
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, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). 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.
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.
Choose Your Healthcare Specialty
Click on your specialty for specific content tailored to your practice.