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.

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.

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-related diagnosis codes

Injectafer claims forms require an appropriate ICD-10-CM code. The following table displays possible ICD-10-CM codes related to IDA^†

Code	Description
D50.0	Iron deficiency anemia secondary to blood loss (chronic)
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)
D64.81	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 for your 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
K50.0-K50.919	Crohn‘s disease (regional enteritis)
K51.0-K51.919	Ulcerative colitis
K90.0	Celiac disease
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

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

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.

For help with reimbursement, contact Daiichi Sankyo Access Central at 1-866-4-DSI-NOW (1-866-437-4669), Monday–Friday,^II 9:00 AM–8:00 PM ET. Click here to learn more.

^IIExcludes holidays.

Which patients can receive Injectafer IV iron?

Injectafer is indicated for the treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease.¹

Learn more about Injectafer.
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.
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.
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.
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
What is the dosing for patients who weigh 50 kg or more?

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two 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
What is the dosing for patients who weigh less than 50 kg?

For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight.¹

Can Injectafer be administered by IV push instead of infusion?

Yes. Injectafer may be administered as an undiluted slow intravenous push. Give at the rate of approximately 100 mg (2 mL) per minute.¹
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
How often can patients be retreated with Injectafer?

Injectafer treatment may be repeated if iron deficiency anemia 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
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
What should I do if extravasation occurs?

Monitor for extravasation, and if it occurs, discontinue the Injectafer administration at that site immediately.¹
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 hypotension^2,3

Click here to review the most common adverse events reported in pivotal trials 1 and 2 for Injectafer.
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, 9:00 AM–8:00 PM ET or visit dsiaccesscentral.com/hcp/injectafer.

References:

Injectafer [package insert]. Shirley, NY: American Regent, Inc.; February 2022.
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.

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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Frequently Asked Questions

Billing and Coding

Product and administration codes

Examples of IDA-related diagnosis codes

A code specific for your IDA patient’s underlying condition^‡