injectafer
Injectafer (Ferric Carboxymaltose) is a parenteral iron replacement.
Ferric Carboxymaltose · by Am Regent
Key facts
- Active ingredient
- Ferric Carboxymaltose
- Drug class
- Parenteral Iron Replacement
- Form
- Injectable
- Strength
- Ferric Carboxymaltose 100MG IRON/2ML (50MG IRON/ML) · Ferric Carboxymaltose 1GM IRON/20ML (50MG IRON/ML) · Ferric Carboxymaltose 500MG IRON/10ML (50MG IRON/ML) · Ferric Carboxymaltose 750MG IRON/15ML (50MG IRON/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Am Regent
- FDA application
- NDA203565
What is Injectafer?
From the FDA label: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(R),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula: [FeO x (OH) y (H 2 O) z ] n [{(C 6 H 10 O 5 ) m (C 6 H 12 O 7 )} l ] k , where n ≈ 10 3 , 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 2 mL, 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. New structure
How to use
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. ( 2.1 ) 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. ( 2.1 ) See Section 2.1, Table 1 for dosage in patients with iron deficiency and heart failure. ( 2.1 ) Injectafer treatment may be repeated if IDA or iron deficiency in heart failure reoccurs. ( 2.3 ) 2.1 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…
Side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypophosphatemia [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…
Warnings
Important safety information
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of each administration. ( 5.1 ) Symptomatic Hypophosphatemia: Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment. ( 5.2 ) Hypertension: Monitor patients closely for signs and symptoms of hypertension following each Injectafer administration. ( 5.3 ) 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 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 [see Dosage and Administration ( 2.3 )] . Treat hypophosphatemia as medically indicated. 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.
Who should not take Injectafer
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.
Overdose — what happens if you take too much
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. In the postmarketing setting, hypophosphatemic osteomalacia has been reported in patients who have received repeated high-cumulative courses of Injectafer.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Storing Injectafer, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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.”
Drug class
How this class works, per Iron Dextran - StatPearls - NCBI Bookshelf.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Use copay cards
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Frequently asked questions
- How does Injectafer work?
- Injectafer is a parenteral iron replacement. Given by injection or IV, these supply iron directly into the bloodstream wrapped in a protective carbohydrate shell. The iron is gradually released, picked up by the protein transferrin, and delivered to the bone marrow, where it is used to build hemoglobin and treat iron-deficiency anemia.
- Is there a coupon or discount for Injectafer?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Injectafer. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Injectafer?
- Injectafer is marketed by Am Regent. You can see Am Regent's full profile, rating, and other products on pharmaranks.
- Is Injectafer a brand-name or generic drug?
- Injectafer is a brand-name product with the active ingredient Ferric Carboxymaltose.
- Is Injectafer available over the counter?
- No. Injectafer is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Injectafer come in?
- Injectafer is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Injectafer?
- Injectafer is classified as parenteral iron replacement, phosphate binder, per the FDA's Established Pharmacologic Class.
- Is Injectafer FDA-registered?
- Injectafer is on record with the U.S. FDA under application number NDA203565. You can verify this on its official FDA label.
- Is Injectafer safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Injectafer. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Injectafer?
- Injectafer's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypophosphatemia [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Labo… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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