Ferumoxytol

Ferumoxytol is an FDA-registered drug product whose active ingredient is FERUMOXYTOL. It is labelled by Sandoz Inc taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0781-3154, application ANDA206604, label effective 20260814. It is one of 2 FDA drug label records sharing the active ingredient FERUMOXYTOL. 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 FERUMOXYTOL are most often described in connection with: oral iron, deficiency anemia, ida adult, unsatisfactory response, chronic kidney, disease ckd, usage ferumoxytol, replacement product. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Ferumoxytol 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 or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product 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 ( 1 ) or • who have chronic kidney disease (CKD). ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dose of ferumoxytol injection is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Take measures to avoid extravasation, as this can lead to skin discoloration or staining, which may be long lasting. If extravasation occurs, discontinue Ferumoxytol administration at that site. Administer while the patient is in a reclined or semi-reclined position. Ferumoxytol injection does not contain antimicrobial preservatives. Discard unused portion. Ferumoxytol injection, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2 to 8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2 to 8° C) for up to 48 hours The dosage is expressed in terms of mg of elemental iron, with each mL of ferumoxytol containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second ferumoxytol infusion. The recommended ferumoxytol injection dose may be readministered to patients with persistent or recurrent iron deficiency anemia. For patients receiving hemodialysis, administer ferumoxytol once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each ferumoxytol infusion. Allow at least 30 minutes between administration of ferumoxytol and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. • The recommended dose of ferumoxytol is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. ( 2 ) • Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. ( 2 )

4 CONTRAINDICATIONS Ferumoxytol injection is contraindicated in patients with: • Known hypersensitivity to ferumoxytol injection or any of its components [see Warnings and Precautions ( 5.1 )] . • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to ferumoxytol injection or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Iron Overload [see Warnings and Precautions ( 5.3 )] • Magnetic Resonance (MR) Imaging Test Interference [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema. (6.1) To report SUSPECTED ADVERSE REACTIONS with ferumoxytol injection, contact Sandoz Inc., at 1-800-525-8747, 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, 3,968 subjects were exposed to ferumoxytol. Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years). The data described below reflect exposure to ferumoxytol in 997 patients exposed to a 1.02 g course of ferumoxytol administered as two 510 mg intravenous (IV) doses: 992 subjects (99.5%) received at least 1 complete dose of ferumoxytol and 946 subjects (94.9%) received 2 complete doses. The mean cumulative IV Iron exposure was 993.80 ±119.085 mg. The safety of ferumoxytol was studied in a randomized, multicenter, double-blind clinical trial in patients with IDA (IDA Trial 3), [see Clinical Studies (14.1)]. In this trial, patients were randomized to two intravenous infusions of 510 mg (1.02 g) of ferumoxytol (n=997), or two intravenous infusions of 750 mg (1.500 g) of ferric carboxymaltose (FCM) (n=1000). Both intravenous irons were infused over a period of at least 15 minutes. Most patients received their second infusion of ferumoxytol and FCM 7(+1) days after Dose 1. The mean (SD) age of the study population (N=1997) was 55.2 (17.16) years. The majority of patients were female (76.1%), white (71.4%) and non-Hispanic (81.8%). The mean (SD) hemoglobin at baseline for all patients was 10.4 (1.5) g/dl. Serious adverse events were reported in 3.6% (71/1997) of ferumoxytol-and FCM-treated patients. The most common (≥2 subjects) serious AEs reported in ferumoxytol-treated patients were syncope, gastroenteritis, seizure, pneumonia, hemorrhagic anemia, and acute kidney injury. In FCM-treated patients the most common (≥2 subjects) serious AEs were syncope, cardiac failure congestive, angina pectoris, and atrial fibrillation. Adverse reactions related to ferumoxytol and reported by ≥ 1% of ferumoxytol-treated patients in IDA Trial 3 are listed in Table 1 . Table 1: Adverse Reactions to Ferumoxytol Reported in ≥1% of IDA Patients in IDA Trial 3 Adverse Reactions Ferumoxytol 2 x 510 mg (N = 997) % Ferric Carboxymaltose 2 x 750 mg (N = 1000) % Headache 3.4 3.1 Nausea 1.8 3.4 Dizziness 1.5 1.6 Fatigue 1.5 1.2 Diarrhea 1 0.8 Back Pain 1 0.4 In IDA Trial 3, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 ferumoxytol-treated patients included arthralgia (0.3%), dyspnea (0.3%), flushing (0.2%), chest discomfort (0.2%), chest pain (0.2%), nausea (0.2%), back pain (0.2%), dizziness (0.2%) and headache (0.2%). Across two clinical trials in patients with IDA (IDA Trial 1 and 2), [see Clinical Studies ( 14.1 )], patients were randomized to: two injections (rapid intravenous injection -prior method of administration no longer approved) of 510 mg of ferumoxytol (n=1,014), placebo (n=200), or five injections/infusions of 200 mg of iron sucrose (n=199). Most patients received their second ferumoxytol injection 3 to 8 days after the first injection. Adverse reactions related to ferumoxytol and reported by ≥ 1% of ferumoxytol-treated patients in these trials were similar to those seen in Trial 3. In Trials 1 and 2, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 ferumoxytol-treated patients included hypersensitivity (0.6%), hypotension (0.3%), and rash (0.2%). In addition, a total of 634 subjects enrolled in and completed participation in a Phase 3 open label extension study. Of these, 337 subjects met IDA treatment criteria and received ferumoxytol. Adverse reactions following this repeat ferumoxytol dosing were generally similar in type and frequency to those observed after the first two intravenous injections. Across three randomized clinical trials in patients with IDA and CKD (CKD Trials 1, 2, and 3), [see Clinical Studies ( 14.2 )], a total of 605 patients were exposed to two injections of 510 mg of ferumoxytol and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days. Most patients received their second ferumoxytol injection 3 to 8 days after the first injection. Adverse reactions related to ferumoxytol and reported by ≥ 1% of ferumoxytol-treated patients in the CKD randomized clinical trials are listed in Table 2 . Diarrhea (4%), constipation (2.1%) and hypertension (1%) have also been reported in ferumoxytol-treated patients. Table 2: Adverse Reactions to Ferumoxytol Reported in ≥1% of Patients with IDA and CKD Trials 1, 2 and 3 Adverse Reactions Ferumoxytol 2 x 510 mg (n = 605) % Oral Iron (n = 280) % Nausea 3.1 7.5 Dizziness 2.6 1.8 Hypotension 2.5 0.4 Peripheral Edema 2 3.2 Headache 1.8 2.1 Edema 1.5 1.4 Vomiting 1.5 5 Abdominal Pain 1.3 1.4 Chest Pain 1.3 0.7 Cough 1.3 1.4 Pruritus 1.2 0.4 Pyrexia 1 0.7 Back Pain 1 0 Muscle Spasms 1 1.4 Dyspnea 1 1.1 Rash 1 0.4 In these clinical trials in patients with IDA and CKD, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 ferumoxytol-treated patients included hypotension (0.4%), chest pain (0.3%), and dizziness (0.3%). Following completion of the controlled phase of the trials, 69 patients received two additional 510 mg intravenous injections of ferumoxytol (for a total cumulative dose of 2.04 g). Adverse reactions following this repeat ferumoxytol dosing were similar in character and frequency to those observed following the first two intravenous injections. 6.2 Postmarketing Experience Because adverse 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 serious adverse reactions have been reported from the post-marketing experience with ferumoxytol: fatal, life-threatening, and serious anaphylactic-type reactions, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of ferumoxytol. Reactions have occurred following the first dose or subsequent doses of ferumoxytol. Extravasation of ferumoxytol at the injection site that may lead to irritation of the skin and potentially long lasting brown discoloration at the site of injection has been reported.

FDA lists 2 drug label records with FERUMOXYTOL 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 Ferumoxytol used for?
1 INDICATIONS AND USAGE Ferumoxytol 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 or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to …

Who makes Ferumoxytol?
Sandoz Inc is the labeler of record for Ferumoxytol. 2 FDA label records share the active ingredient FERUMOXYTOL, 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 Ferumoxytol 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 Ferumoxytol 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 FERUMOXYTOL?
Yes. 2 FDA drug label records list FERUMOXYTOL 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 Ferumoxytol 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.