NDC 0517-0620 Injectafer

Ferric Carboxymaltose Injection, Solution Intravenous

NDC Product Code 0517-0620

NDC CODE: 0517-0620

Proprietary Name: Injectafer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ferric Carboxymaltose What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat "iron-poor" blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease. Iron is an important mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.

NDC Code Structure

NDC 0517-0620-01

Package Description: 1 VIAL, SINGLE-DOSE in 1 BOX > 20 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Injectafer with NDC 0517-0620 is a human prescription drug product labeled by American Regent, Inc.. The generic name of Injectafer is ferric carboxymaltose. The product's dosage form is injection, solution and is administered via intravenous form.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Injectafer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates multiple concept unique identifiers (RXCUI) are associated with this product:

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Regent, Inc.
Labeler Code: 0517
FDA Application Number: NDA203565 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2023 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Injectafer Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Recent Major Changes

Warnings and Precautions, Symptomatic Hypophosphatemia. (5.2)     02/2020

1 Indications And Usage

  • Injectafer is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:who have intolerance to oral iron or have had unsatisfactory response to oral iron, orwho have non-dialysis dependent chronic kidney disease.

For patients weighing 50 kg or more, the recommended dosage is Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course.  Alternatively, for patients weighing 50 kg or more, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single dose treatment course.For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course.Each mL of Injectafer contains 50 mg of elemental iron.

2.2 Preparation And Administration

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion.  When administered via infusion, dilute up to 1,000 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 less than 2 mg of iron per mL and administer over at least 15 minutes.When added to an infusion bag containing 0.9% sodium chloride injection, USP, 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.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-dose only.When administering Injectafer 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute.  For Injectafer 1,000 mg, administer as a slow intravenous push over 15 minutes.  Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long lasting.  Monitor for extravasation.  If extravasation occurs, discontinue the Injectafer administration at that site.Discard unused portion.

2.3  Repeat Treatment Monitoring Safety Assessment

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 [see Warnings and Precautions (5.2)].

3 Dosage Forms And Strengths

  • Injection: 50 mg/mL, dark brown, non-transparent, sterile, aqueous solution.750 mg iron/15 mL single-dose vial1,000 mg iron/20 mL single-dose vial

4 Contraindications

Injectafer is contraindicated in patients with a history of hypersensitivity to Injectafer or any of its components [see Warnings and Precautions (5.1)].

5.1 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. [see Adverse Reactions (6.1, 6.2)].  In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1,775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1,775) of these subjects.

5.2  Symptomatic Hypophosphatemia

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 [see Dosage and Administration (2.3)].

5.3 Hypertension

In clinical studies, hypertension was reported in 4% (67/1,775) 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% (106/1,775) 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 [see Dosage and Administration (2)].

5.4 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.

6 Adverse Reactions

  • The following adverse reactions are discussed in greater detail in other sections of the labeling:Hypersensitivity Reactions [see Warnings and Precautions (5.1)]Hypertension [see Warnings and Precautions (5.2)]Laboratory Test Alterations [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.In two randomized clinical studies [Studies 1 and 2, see Clinical Studies (14)], a total of 1,775 patients were exposed to Injectafer 15 mg/kg 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 1,500 mg of iron.Adverse reactions reported by ≥1% of treated patients are shown in the following table.   Table 1.   Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2Injectafer(N=1,775)%Pooled ComparatorsIncludes oral iron and all formulations of IV iron other than Injectafer (N=1,783)%Oraliron(N=253)%Nausea7.221.2Hypertension*420.4Flushing*40.20Injection site reactions*33.20 Eythema*30.60 Hypophosphatemia2.10.10Dizziness* Site Discoloration**1.40.30Headache* enzyme increased*1.20.20Dysgeusia*1.22.10Hypotension120 Rash*10.30Constipation0.50.93.2*Grouped Terms:Hypertension includes hypertension, blood pressure increased, and hypertensive crisis.Flushing includes flushing and hot flush.Injection site reactions include injection site extravasation, injection site discoloration, injection site pain, injection site irritation, injection site bruising, injection site reaction, injection site discomfort, injection site erythema, injection site hematoma, injection site hemorrhage, injection site pruritus, injection site rash, and injection site swelling.Erythema includes erythema and injection site erythema.Dizziness includes dizziness, balance disorder, and vertigo.**Injection site discoloration was also included in the injection site local administration reactions grouped term.Headache includes headache and migraine.Hepatic enzyme increased includes alanine aminotransferase increased and aspartate aminotransferase increased.Dysgeusia includes dysgeusia and ageusia.Rash includes rash, urticaria, skin exfoliation, blister, erythema multiforme, injection site rash, rash maculo-papular, and rash pruritic.Other adverse reactions reported by ≥0.5% of treated patients include abdominal pain, diarrhea, gamma glutamyl transferase increased, paresthesia, and sneezing. Transient decreases in laboratory blood phosphorus levels (< 2 mg/dL) have been observed in 27% (440/1,638) of patients in clinical trials.Pooled data from two Phase 3 studies 1VIT09030 (NCT00981045) and 1VIT09031 (NCT00982007) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg of iron were analyzed to compare rates of adverse reactions in two Phase 3 parallel group studies 1VIT07017 (NCT00548860) and 1VIT07018 (NCT00548691) with a dosing regimen of Injectafer 15 mg/kg up to a maximum of 1,000 mg single dose (Table 2).Table 2. Adverse Reactions (≥1% in any Treatment Group) In Patients Receiving a Single dose of Injectafer 15 mg/kg to a Maximum of 1,000 mg or Two Doses of 15 mg/kg to a Maximum of 750 mg to a Cumulative dose of 1,500 mgInjectafer 15 mg/kg to a maximum of 750 mg x 2 dosesto a cumulative dose of 1,500 mgInjectafer 15 mg/kg to a maximum of 1,000 mg single doseIVIT09030 and IVIT09031b (n=1,775)%IVIT07017 and IVIT07018a(n=1,200)%Any Adverse Reaction2412Injection site reactions* 34Injection site extravasation**0.22Hepatic enzyme increased* 1.21.2Rash* 11.2Headache*1.31Dizziness* 2.11Dysgeusia* 1.21Nausea 7.21Hypertension*41Hypophosphatemia2.11Erythema*30.3Flushing*40.3Vomiting 20.2Injection site discoloration**1.4<0.1Hypotension1<0.1ab Included studies 1VIT07017, 1VIT07018, 1VIT09030 and 1VIT09031*Grouped Terms **Injection site extravasation and injection site discoloration were also included in the injection site reactions grouped term.

6.2 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:  urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope. One case of hypophosphatemic osteomalacia was reported in a subject who received 500 mg of Injectafer every 2 weeks for a total of 16 weeks.  Partial recovery followed discontinuation of Injectafer. Cardiac disorders: TachycardiaGeneral disorders and administration site conditions: Chest discomfort, chills, pyrexiaMetabolism and nutrition disorders: HypophosphatemiaMusculoskeletal and connective tissue disorders: Arthralgia, back pain, hypophosphatemic osteomalacia (rarely reported event)Nervous system disorders: SyncopeRespiratory, thoracic and mediastinal disorders: DyspneaSkin and subcutaneous tissue disorders: Angioedema, erythema, pruritus, urticariaPregnancy: Fetal bradycardia

8.1 Pregnancy

Risk SummaryParenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant women of the potential risk to a fetus.  Published studies and available data from postmarketing reports with intravenous Injectafer are insufficient to assess the risk of major birth defects and miscarriage.  There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations).In animal reproduction studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused adverse developmental outcomes including fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area).   The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Clinical ConsiderationsDisease-associated maternal and/or embryo/fetal riskUntreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia.  Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.Fetal/Neonatal adverse reactionsSevere 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.DataHuman DataPublished data from randomized controlled studies, prospective observational studies and retrospective studies on the use of ferric carboxymaltose in pregnant women have not reported an association with intravenous ferric carboxymaltose and major birth defects and miscarriage.  However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy.   Animal DataAdministration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal findings.  This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area.  In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day.  Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg).  Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose of 750 mg based on body surface area).  Pre-implantation loss was at the highest dose.  Adverse embryonic or fetal effects were observed in the presence of maternal toxicity.A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg based on body surface area).  There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters.

8.2 Lactation

Risk SummaryThe available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk.  Among the breastfed infants, adverse reactions included constipation and diarrhea but none of the adverse reactions reported were considered related to ferric carboxymaltose exposure through breastmilk. There is no information on the effects of ferric carboxymaltose on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Injectafer in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

8.5 Geriatric Use

Of the 1,775 subjects in clinical studies of Injectafer, 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

10 Overdosage

Excessive dosages of Injectafer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. A patient who received Injectafer 18,000 mg over 6 months developed hemosiderosis with multiple joint disorder, walking disability, and asthenia. Hypophosphatemic osteomalacia was reported in a patient who received Injectafer 4,000 mg over 4 months. Partial recovery followed discontinuation of Injectafer.

11 Description

Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula:[FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k,  where n ≈ 103, m ≈ 8, l ≈ 11, and k ≈ 4(l represents the mean branching degree of the ligand). The chemical structure is presented below:Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection.  Injectafer is available in 15 mL and 20 mL single-dose vials.  Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex.

12.1 Mechanism Of Action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

12.2 Pharmacodynamics

Using positron emission tomography (PET) it was demonstrated that red cell uptake of 59Fe and 52Fe from Injectafer ranged from 61% to 99%. In patients with iron deficiency, red cell uptake of radio-labeled iron ranged from 91% to 99% at 24 days after Injectafer dose. In patients with renal anemia, red cell uptake of radio-labeled iron ranged from 61% to 84% at 24 days after Injectafer dose.

12.3 Pharmacokinetics

After administration of a single dose of Injectafer of 100 to 1,000 mg of iron in iron deficient patients, maximum iron concentration of 37 µg/mL to 333 µg/mL were obtained respectively after 15 minutes to 1.21 hours post dose. The volume of distribution was estimated to be 3 L.The iron injected or infused was rapidly cleared from the plasma, the terminal half-life ranged from 7 to 12 hours. Renal elimination of iron was negligible.

13.1 Carcinogenesis And Mutagenesis And Impairment Of Fertility

Carcinogenicity studies have not been performed with ferric carboxymaltose.Ferric carboxymaltose was not genotoxic in the following genetic toxicology studies: in vitro microbial mutagenesis (Ames) assay, in vitro chromosome aberration test in human lymphocytes, in vitro mammalian cell mutation assay in mouse lymphoma L5178Y/TK+/- cells, in vivo mouse micronucleus test at single intravenous doses up to 500 mg/kg.  In a combined male and female fertility study, ferric carboxymaltose was administered intravenously over one hour to male and female rats at iron doses of up to 30 mg/kg.  Animals were dosed 3 times per week (on Days 0, 3, and 7).  There was no effect on mating function, fertility or early embryonic development.  Based on body surface area, the dose of 30 mg/kg in animals is approximately 40% of the human dose of 750 mg.

14 Clinical Studies

The safety and efficacy of Injectafer for treatment of IDA were evaluated in two randomized, open-label, controlled clinical trials (Trial 1 and Trial 2).  In these two trials, Injectafer was administered at a dose of 15 mg/kg 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 1,500 mg of iron.

14.1 Trial 1: Iron Deficiency Anemia In Patients Who Are Intolerant To Oral Iron Or Have Had Unsatisfactory Response To Oral Iron

Trial 1: A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients with Iron Deficiency Anemia (IDA), (NCT00982007) was a randomized, open-label, controlled clinical study in patients with IDA who had an unsatisfactory response to oral iron (Cohort 1) or who were intolerant to oral iron (Cohort 2) during the 14-day oral iron run-in period. Inclusion criteria prior to randomization included hemoglobin (Hb) <12 g/dL, ferritin ≤100 ng/mL or ferritin ≤300 ng/mL when transferrin saturation (TSAT) ≤30%. Cohort 1 subjects were randomized to Injectafer or oral iron for 14 more days.  Cohort 2 subjects were randomized to Injectafer or another IV iron per standard of care [90% of subjects received iron sucrose]. The mean age of study patients was 43 years (range, 18 to 94); 94% were female; 42% were Caucasian, 32% were African American, 24% were Hispanic, and 2% were other races. The primary etiologies of IDA were heavy uterine bleeding (47%) and gastrointestinal disorders (17%).Table 3 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 35 or time of intervention.  Table 3. Mean Change in Hemoglobin From Baseline to the Highest Value Between Day 35 or Time of Intervention (Modified Intent‑to‑Treat Population)Hemoglobin (g/dL)Mean (SD)Cohort 1Cohort 2Injectafer(N=244)Oral Iron(N=251)Injectafer(N=245)IV SCa(N=237)Baseline           10.6 (1.0)10.6 (1.0)9.1 (1.6)9.0 (1.5)Highest Value12.2 (1.1)11.4 (1.2)12.0 (1.2)11.2 (1.3)Change (from baseline to highest value)1.6 (1.2)0.8 (0.8)2.9 (1.6)2.2 (1.3)p-value0.0010.001SD=standard deviation; a: Intravenous iron per standard of careIncreases from baseline in mean ferritin (264.2 ± 224.2 ng/mL in Cohort 1 and 218.2 ± 211.4 ng/mL in Cohort 2), and transferrin saturation (13 ± 16% in Cohort 1 and 20 ± 15% in Cohort 2) were observed at Day 35 in Injectafer-treated patients.

14.2 Trial 2: Iron Deficiency Anemia In Patients With Non-Dialysis Dependent Chronic Kidney Disease

Trial 2: REPAIR-IDA, Randomized Evaluation of efficacy and safety of Ferric Carboxymaltose in Patients with Iron Deficiency Anemia and Impaired Renal function, (NCT00981045) was a randomized, open-label, controlled clinical study in patients with non-dialysis dependent chronic kidney disease. Inclusion criteria included hemoglobin (Hb) ≤11.5 g/dL, ferritin ≤ 100 ng/mL or ferritin ≤300 ng/mL when transferrin saturation (TSAT) ≤ 30%.  Study patients were randomized to either Injectafer or Venofer. The mean age of study patients was 67 years (range, 19 to 101); 64% were female; 54% were Caucasian, 26% were African American, 18% Hispanics, and 2% were other races. Table 4 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 56 or time of intervention.  Table 4. Mean Change in Hemoglobin From Baseline to the Highest Value Between Baseline  and Day 56 or Time of Intervention (Modified Intent‑to‑Treat Population)Hemoglobin (g/dL)Mean (SD)Injectafer(N=1,249)Venofer(N=1,244)Baseline10.3 (0.8)10.3 (0.8)Highest Value 11.4 (1.2)11.3 (1.1)Change (from baseline to highest value)1.1 (1.0)0.9 (0.92)Treatment Difference (95% CI)0.21 (0.13, 0.28)Increases from baseline in mean ferritin (734.7 ± 337.8 ng/mL), and transferrin saturation (30 ± 17%) were observed prior to Day 56 in Injectafer-treated patients.

16 How Supplied/Storage And Handling

Injectafer (ferric carboxymaltose injection) is a dark brown, non-transparent, sterile, aqueous solution.NDC 0517-0650-01           750 mg iron/15 mL Single-Dose Vial        Individually BoxedNDC 0517-0620-01           1,000 mg iron/20 mL Single-Dose Vial        Individually BoxedStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature].  Do not freeze.

17 Patient Counseling Information

Prior History of Reactions to Parenteral Iron ProductsQuestion patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions (5.1)].Serious Hypersensitivity ReactionsAdvise patients to report any signs and symptoms of hypersensitivity that may develop during and following Injectafer administration, such as rash, itching, dizziness, lightheadedness, swelling, and breathing problems [see Warnings and Precautions (5.1)].PregnancyAdvise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].Injectafer is manufactured under license from Vifor (International) Inc, Switzerland.AMERICANREGENT, INC.SHIRLEY, NY  11967RQ1052-D

Patient Information

  • INJECTAFER (in-jekt-a-fer)(ferric carboxymaltose injection)What is INJECTAFER?INJECTAFER is a prescription iron replacement medicine used to treat IDA in adults who have:intolerance to oral iron or who have not responded well to treatment with oral iron, ornon-dialysis dependent chronic kidney disease It is not known if INJECTAFER is safe and effective for use in children. Who should not receive INJECTAFER?Do not receive INJECTAFER if you are allergic to ferric carboxymaltose or any of the ingredients in INJECTAFER. See the end of this leaflet for a complete list of ingredients in INJECTAFER.Before receiving INJECTAFER, tell your healthcare provider about all of your medical conditions, including if you:have had an allergic reaction to iron given into your veinhave high blood pressure are pregnant or plan to become pregnant. It is not known if INJECTAFER will harm your unborn baby.are breastfeeding or plan to breastfeed. INJECTAFER passes into your breast milk.  It is unknown whether INJECTAFER would pose a risk to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with INJECTAFER.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive INJECTAFER?INJECTAFER is given intravenously (into your vein) by your healthcare provider in 2 doses at least 7 days apart or given as a single dose.What are the possible side effects of INJECTAFER?INJECTAFER may cause serious side effects, including:Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive INJECTAFER. Other serious reactions including itching, hives, wheezing, and low blood pressure also have happened during treatment with INJECTAFER. Tell your healthcare provider if you have ever had any unusual or allergic reaction to any iron given by vein.High blood pressure (hypertension). High blood pressure, sometimes with face flushing, dizziness, or nausea, has happened during treatment with INJECTAFER. Your healthcare provider will check your blood pressure and check for any signs and symptoms of high blood pressure after you receive INJECTAFER. The most common side effects of INJECTAFER include:nauseahigh blood pressureflushinglow levels of phosphorous in your blooddizzinessThese are not all the possible side effects of INJECTAFER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about INJECTAFERMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about INJECTAFER that is written for health professionals. What are the ingredients in INJECTAFER?Active ingredient: ferric carboxymaltoseInactive ingredients: water for injection. Sodium hydroxide and/or hydrochloric acid may have been added to adjust pH to 5.0-7.0.For more information go to www.injectafer.com or call 1-800-734-9236.This Patient information has been approved by the U.S. Food and Drug Administration.AMERICANREGENT, INC.SHIRLEY, NY  11967Revised: 04/2021

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