Injectafer

Injectafer is an FDA-registered drug product whose active ingredient is FERRIC CARBOXYMALTOSE INJECTION. It is labelled by American Regent, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0517-0602, application NDA203565, label effective 20260819. It is one of 2 FDA drug label records sharing the active ingredient FERRIC CARBOXYMALTOSE INJECTION. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FERRIC CARBOXYMALTOSE INJECTION are most often described in connection with: iron deficiency, adult patients, anemia ida, year age, either intolerance, unsatisfactory response, non-dialysis dependent, chronic kidney. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Injectafer 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. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Injectafer is an iron replacement product 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. ( 1 ) adult patients who have non-dialysis dependent chronic kidney disease. ( 1 ) • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. ( 1 )

2 DOSAGE AND ADMINISTRATION 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. For adult patients weighing 50 kg or more, an alternative dose of Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. ( 2.2 ) 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. ( 2.2 ) See Section 2.2, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.2 ) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 ) 2.1 Laboratory Testing 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 repeat course of therapy within three months [see Boxed Warning and Dosage and Administration (2.3)]. Correct pre-existing hypophosphatemia prior to administering Injectafer [see Warnings and Precautions (5.1)]. 2.2 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia 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. In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per 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. Recommended Dosage in Patients with Iron Deficiency with Heart Failure See Table 1 for recommended dosage for treatment of iron deficiency in patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Table 1: Recommended Dosage in Patients with Iron Deficiency with Heart Failure Weight less than 70 kg Weight 70 kg or more Hb (g/dL) Hb (g/dL) < 10 10 to 14 > 14 to < 15 < 10 10 to 14 > 14 to < 15 Day 1 1,000 mg 1,000 mg 500 mg 1,000 mg 1,000 mg 500 mg Week 6 500 mg No dose No dose 1,000 mg 500 mg No dose Administer a maintenance dose of 500 mg at 12, 24 and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%. There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL. 2.3 Repeat Dosage Courses Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. 2.4 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 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 a single dose. When administering Injectafer 500 or 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.

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 ) ]. Hypersensitivity to Injectafer or any of its inactive components.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. ( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. Adults 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 2. Adverse reactions reported in ≥1% of Study Patients in Clinical Trials 1 and 2 Injectafer (N=1,775) % Pooled Comparators a (N=1,783) % Oral iron (N=253) % Nausea 7.2 2 1.2 Hypertension* 4 2 0.4 Flushing* 4 0.2 0 Injection site reactions* 3 3.2 0 Erythema* 3 0.6 0 Hypophosphatemia 2.1 0.1 0 Dizziness* 2.1 1.3 0.4 Vomiting 2 1 0.4 Injection Site Discoloration** 1.4 0.3 0 Headache* 1.3 1.2 0.4 Hepatic enzyme increased* 1.2 0.2 0 Dysgeusia* 1.2 2.1 0 Hypotension 1 2 0 Rash* 1 0.3 0 Constipation 0.5 0.9 3.2 a Includes oral iron and all formulations of IV iron other than Injectafer *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 3). Table 3. Adverse Reactions (≥1% in any Treatment Group) In Patients Receiving Two Doses of 15 mg/kg to a Maximum of 750 mg to a Cumulative Dose of 1,500 mg or a Single Dose of Injectafer 15 mg/kg to a Maximum of 1,000 mg Injectafer 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg Injectafer 15 mg/kg to a maximum of 1,000 mg single dose IVIT09030 and IVIT09031 b (N=1,775) % IVIT07017 and IVIT07018 a (N=1,200) % Any Adverse Reaction 24 12 Injection site reactions* 3 4 Injection site extravasation** 0.2 2 Hepatic enzyme increased* 1.2 1.2 Rash* 1 1.2 Headache* 1.3 1 Dizziness* 2.1 1 Dysgeusia* 1.2 1 Nausea 7.2 1 Hypertension* 4 1 Hypophosphatemia 2.1 1 Erythema* 3 0.3 Flushing* 4 0.3 Vomiting 2 0.2 Injection site discoloration** 1.4 <0.1 Hypotension 1 <0.1 ab 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. Pediatric Patients The safety of Injectafer in pediatric patients was evaluated in study 1VIT17044 (NCT03523117; Study 3). Study 1VIT17044 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 1,500 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. Table 4 summarizes the adverse reactions in Study 3. Table 4. Adverse Reactions of any Grade in Pediatric Patients Receiving Injectafer in Study 3 Injectafer (N=40) % Oral Ferrous Sulfate (N=38) % Any Adverse Reactions 35 26 Hypophosphatemia* 13 0 Injection site reactions* 8 0 Rash* 8 0 Headache 5 3 Vomiting 5 3 Nasopharyngitis 3 5 Flushing 3 0 Gastrointestinal infections 3 0 Liver function test increased 3 0 Platelet count decreased 3 0 White blood cell count decreased 3 0 *Grouped Terms Injection site reactions include infusion site hematoma, infusion site hypoesthesia and injection site pain. Hypophosphatemia includes hypophosphatemia and blood phosphorus decreased. Rash includes rash, exanthema and urticaria. 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 1,016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications. 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: 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

FDA lists 2 drug label records with FERRIC CARBOXYMALTOSE INJECTION as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Injectafer used for?
1 INDICATIONS AND USAGE Injectafer 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. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class …

Who makes Injectafer?
American Regent, Inc. is the labeler of record for Injectafer. 2 FDA label records share the active ingredient FERRIC CARBOXYMALTOSE INJECTION, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Injectafer come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Injectafer prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FERRIC CARBOXYMALTOSE INJECTION?
Yes. 2 FDA drug label records list FERRIC CARBOXYMALTOSE INJECTION as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Injectafer been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.