Drugs Details

Drugs Info of Feraheme
Drugs Details
  • Drugs Type  : Multum
  • Date : 30th Jan 2015 05:46 am
  • Brand Name : Feraheme
  • Generic Name : ferumoxytol (Pronunciation: FER ue MOX i tol)
Descriptions

Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme is Fe5874O8752C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa.

Feraheme injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.

What are the possible side effects of ferumoxytol (Feraheme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Call your doctor at once if you have serious side effects such as:

  • feeling like you might pass out;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • easy bruising;
  • swelling where the medicine was injected; or
  • worsening symptoms of kidney failure...

Read All Potential Side Effects and See Pictures of Feraheme »

What are the precautions when taking ferumoxytol injection (Feraheme)?

Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI...

Read All Potential Precautions of Feraheme »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).

Dosage Administration

The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme intravenously, either as an undiluted slow intravenous injection or by infusion.

 

Administration Rate of delivery Dilution
Undiluted intravenous injection 1 mL/sec (30 mg/sec) At least 17 seconds No Dilution
Diluted intravenous infusion At least 15 minutes Dilute in 50 to 200 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

Feraheme, when added to intravenous infusion bags containing either Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 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.

The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme injection. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

For patients receiving hemodialysis, administer Feraheme 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 Feraheme injection.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

How Supplied

Dosage Forms And Strengths

Feraheme Injection is available in single use vials. Each vial contains 510 mg of elemental iron in 17 mL.

Storage And Handling

Feraheme is available in single use vials in the following package sizes (Table 3).

Table 3: Feraheme Packaging Description

NDC Code Dose / Total volume per vial Vials / Carton
NDC 59338-775-01 510 mg/ 17 mL 1
NDC 59338-775-10 510 mg/ 17 mL 10
Stability And Storage

Store at 20° to 25°C (68°to 77°F). Excursions permitted to 15°– 30°C (59°– 86°F) [see USP controlled room temperature].

Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451. Revised: December 2013

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Feraheme injection may cause serious hypersensitivity reactions and hypotension [see WARNINGS AND PRECAUTIONS].

In clinical studies, 1,726 subjects were exposed to Feraheme; 1,562 of these had CKD and 164 did not have CKD. Of these subjects 46% were male and the median age was 63 years (range of 18 to 96 years).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.

Adverse Reactions In Clinical Studies

Across the three randomized clinical trials [Trial 1, 2, and 3, see Clinical Studies], a total of 605 patients were exposed to two injections of 510 mg of Feraheme and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days. Most patients received their second Feraheme injection 3 to 8 days after the first injection.

Adverse reactions related to Feraheme and reported by ≥ 1% of Feraheme-treated patients in the randomized clinical trials are listed in Table 1. Diarrhea (4.0%), constipation (2.1%) and hypertension (1.0%) have also been reported in Feraheme-treated patients.

Table 1: Adverse Reactions to Feraheme Reported in ≥ 1% of Patients with CKD

Adverse Reactions Feraheme 2 x 510 mg
(n = 605)
Oral Iron
(n = 280)
Nausea 3.10% 7.50%
Dizziness 2.60% 1.80%
Hypotension 2.50% 0.40%
Peripheral Edema 2.00% 3.20%
Headache 1.80% 2.10%
Edema 1.50% 1.40%
Vomiting 1.50% 5.00%
Abdominal Pain 1.30% 1.40%
Chest Pain 1.30% 0.70%
Cough 1.30% 1.40%
Pruritus 1.20% 0.40%
Pyrexia 1.00% 0.70%
Back Pain 1.00% 0%
Muscle Spasms 1.00% 1.40%
Dyspnea 1.00% 1.10%
Rash 1.00% 0.40%

In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Following completion of the controlled phase of the trials, 69 patients received two additional 510 mg intravenous injections of Feraheme (for a total cumulative dose of 2.04 g). Adverse reactions following this repeat Feraheme dosing were similar in character and frequency to those observed following the first two intravenous injections.

In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Feraheme. Adverse reactions reported by these patients were similar in character and frequency to those observed in other clinical trials.

Adverse Reactions From Post-Marketing Spontaneous Reports

The following adverse reactions have been identified during post-approval use of Feraheme. 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 serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, 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 occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

Read the Feraheme (ferumoxytol injection) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the absorption of concomitantly administered oral iron preparations.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see ADVERSE REACTIONS]. Anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience [see ADVERSE REACTIONS from Post-marketing Spontaneous Reports]. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects.

Hypotension

Severe adverse reactions of clinically significant hypotension have been reported. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Hypotension has also been reported in the post-marketing experience [see ADVERSE REACTIONS from Post-marketing Spontaneous Reports]. Monitor patients for signs and symptoms of hypotension following each Feraheme administration [see DOSAGE AND ADMINISTRATION].

Iron Overload

Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy [see DOSAGE AND ADMINISTRATION]. Do not administer Feraheme to patients with iron overload.

In the 24 hours following administration of Feraheme, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Feraheme complex.

Magnetic Resonance (MR) Imaging

Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Anticipated MR imaging studies should be conducted prior to the administration of Feraheme.

Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. If MR imaging is required within 3 months after Feraheme administration, use T1-or proton density-weighted MR pulse sequences to minimize the Feraheme effects; MR imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of Feraheme. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration [see CLINICAL PHARMACOLOGY].

Feraheme will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Ferumoxytol was not tested for carcinogenic effects. In standard genotoxicity tests, ferumoxytol showed no evidence of mutagenic activity in an in vitro Ames test or clastogenic activity in either an in vitro chromosomal aberration assay or an in vivo micronucleus assay.

No adverse effects on fertility or general reproductive performance were noted in animal studies. Ferumoxytol had no effect on male or female fertility or general reproductive function in rats.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no studies of Feraheme in pregnant women. In animal studies, ferumoxytol caused fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. Use Feraheme during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights. In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and/or soft tissue fetal malformations and decreased fetal weights.

Nursing Mothers

It is not known whether Feraheme is present in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to avoid Feraheme, taking into account the importance of Feraheme to the mother and the known benefits of nursing.

Pediatric Use

The safety and effectiveness of Feraheme in pediatric patients have not been established.

Geriatric Use

In controlled clinical trials, 330 patients ≥ 65 years of age were treated with Feraheme. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see DOSAGE AND ADMINISTRATION and Clinical Studies].

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No data are available regarding overdosage of Feraheme in humans. Excessive dosages of Feraheme may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Feraheme to patients with iron overload [WARNINGS AND PRECAUTIONS].

ContrainDications

Feraheme is contraindicated in patients with:

  • Known hypersensitivity to Feraheme or any of its components

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

Pharmacodynamics

Cardiac Electrophysiology

In a randomized, positive- and placebo-controlled, parallel-group study, healthy subjects received a supratherapeutic regimen of Feraheme (1.02 g given as two 510 mg doses within 24 hours), placebo or a single dose of 400 mg moxifloxacin (positive control). Results demonstrated no effect of Feraheme on QT interval durations. No clinically meaningful effect of Feraheme on heart rate was observed.

Pharmacokinetics

The pharmacokinetic (PK) behavior of Feraheme has been examined in healthy subjects and in patients with CKD stage 5D on hemodialysis. Feraheme exhibited dose-dependent, capacity-limited elimination from plasma with a half life of approximately 15 hours in humans. The clearance (CL) was decreased by increasing the dose of Feraheme. Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (Cmax) and terminal half-life (t½) values increased with dose. The estimated values of CL and Vd following two 510 mg doses of Feraheme administered intravenously within 24 hours were 69.1 mL/hr and 3.16 L, respectively. The Cmax and time of maximum concentration (tmax) were 206 mcg/mL and 0.32 hr, respectively. Rate of infusion had no influence on Feraheme PK parameters. No gender differences in Feraheme PK parameters were observed. Feraheme is not removed by hemodialysis.

Clinical Studies

The safety and efficacy of Feraheme for the episodic treatment of iron deficiency anemia in patients with CKD were assessed in three randomized, open-label, controlled clinical trials (Trial 1, 2 and 3). These trials also included an uncontrolled, follow-up phase in which patients with persistent iron deficiency anemia could receive two additional 510 mg intravenous injections of Feraheme. The major efficacy results from the controlled phase of each study are shown in Table 2.

In all three trials, patients with CKD and iron deficiency anemia were randomized to treatment with Feraheme or oral iron. Feraheme was administered as two 510 mg intravenous single doses and oral iron (ferrous fumarate) was administered as a total daily dose of 200 mg elemental iron daily for 21 days. The major trial outcomes assessed the change in hemoglobin from baseline to Day 35. Trial 1 and 2 enrolled patients with non-dialysis dependent CKD and Trial 3 enrolled patients who were undergoing hemodialysis.

In Trial 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races. In the Feraheme and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at baseline.

In Trial 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races. In the Feraheme and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at baseline.

In Trial 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races. All patients were receiving ESAs.

Table 2 shows the Baseline and mean change to Day 35 in hemoglobin (Hgb, g/dL), transferrin saturation (TSAT, %) and ferritin (ng/mL) in each treatment group for Trial 1, 2, and 3.

Table 2: Changes from Baseline to Day 35 in Hemoglobin, Transferrin Saturation and Ferritin (Intent to Treat Population)

View Enlarged Table

Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anemic could receive two additional 510 mg intravenous injections of Feraheme for a total cumulative dose of 2.04 g. Overall, 69 patients received two additional 510 mg intravenous injections of Feraheme, and on Day 35 following these additional injections, the majority of these patients (70%) experienced an increase in hemoglobin and iron parameters (TSAT and ferritin). The mean change (±SD) in hemoglobin level from the retreatment baseline for patients with an increase in hemoglobin was 0.86 (± 0.68) g/dL and was 0.5 (± 0.8) g/dL for all patients.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Prior To Feraheme administration

  • Question patients regarding any prior history of reactions to parenteral iron products.
  • Advise patients of the risks associated with Feraheme.
  • Advise patient to report any signs and symptoms of hypersensitivity that may develop during and following Feraheme administration, such as rash, itching, dizziness, lightheadedness, swelling and breathing problems [see WARNINGS AND PRECAUTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This 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 for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FERUMOXYTOL - INJECTION

 

(FER-ue-MOX-i-tol)

 

COMMON BRAND NAME(S): Feraheme

 

USES: This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. It is a form of iron that must be given by injection. You may need extra iron because of blood loss during kidney dialysis treatment.

Iron is an important part of your red blood cells and is needed to carry oxygen throughout the body. Many patients with kidney disease cannot get enough iron from food and require injections.

 

HOW TO USE: This medication will be given by a health care professional. It is given slowly into a vein (IV), usually in a clinic or in a hospital. Treatment involves receiving two doses of ferumoxytol, given 3 to 8 days apart during dialysis.

The dosage is based on your medical condition and response to treatment. Your doctor will take blood tests to monitor your treatment.

Consumer Overview Side Effect

SIDE EFFECTS: Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness or fainting, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bruising, skin darkens (bronze tone), swelling of hands/feet/lower legs, chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Feraheme (ferumoxytol injection) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI scan.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other iron products.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (such as complete blood count, iron level) should be performed periodically to monitor your progress or check for side effects. Make sure you keep all your medical and laboratory appointments.

It is important to eat a well-balanced diet to get enough iron, vitamins, and minerals. Good sources of iron include meats (especially liver), eggs, raisins, figs, broccoli, brussels sprouts, beans, lentils, and iron-fortified or enriched cereals. Follow diet recommendations for your condition.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Feraheme

Generic Name: ferumoxytol (Pronunciation: FER ue MOX i tol)

  • What is ferumoxytol (Feraheme)?
  • What are the possible side effects of ferumoxytol (Feraheme)?
  • What is the most important information I should know about ferumoxytol (Feraheme)?
  • What should I discuss with my healthcare provider before receiving ferumoxytol (Feraheme)?
  • How is ferumoxytol given (Feraheme)?
  • What happens if I miss a dose (Feraheme)?
  • What happens if I overdose (Feraheme)?
  • What should I avoid while using ferumoxytol (Feraheme)?
  • What other drugs will affect ferumoxytol (Feraheme)?
  • Where can I get more information?

What is ferumoxytol (Feraheme)?

Ferumoxytol is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Ferumoxytol is used to treat iron deficiency anemia in people with chronic kidney disease. Anemia is a lack of red blood cells caused by having too little iron in the body.

Ferumoxytol may also be used for purposes not listed in this medication guide.

What are the possible side effects of ferumoxytol (Feraheme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Call your doctor at once if you have serious side effects such as:

  • feeling like you might pass out;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • easy bruising;
  • swelling where the medicine was injected; or
  • worsening symptoms of kidney failure (urinating less than usual or not at all, confusion, mood changes, increased thirst, loss of appetite, swelling, weight gain, feeling short of breath).

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • headache, dizziness;
  • swelling in your hands or feet;
  • chest pain; or
  • cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Feraheme (ferumoxytol injection) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about ferumoxytol (Feraheme)?

You should not use this medication if you have ever had an allergic reaction to an injectable form of iron (including ferumoxytol), or if you have iron overload syndrome or any type of anemia that is not caused by iron deficiency.

Before you receive ferumoxytol, tell your doctor if you are on dialysis.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with ferumoxytol. Visit your doctor regularly.

Ferumoxytol can cause unusual results with magnetic resonance imaging (MRI) tests for up to 3 months after you receive this medication. Tell any doctor who treats you that you have received a ferumoxytol injection within the past 3 months.

Ferumoxytol will not affect other types of X-rays, CT scans, ultrasounds, or nuclear radiation imaging.

Side Effects Centers
  • Feraheme

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving ferumoxytol (Feraheme)?

You should not use this medication if you have ever had an allergic reaction to an injectable form of iron (including ferumoxytol), or if you have:

  • iron load syndrome; or
  • any type of anemia that is not caused by iron deficiency.

Before you receive ferumoxytol, tell your doctor if you are on dialysis.

FDA pregnancy category C. It is not known whether ferumoxytol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ferumoxytol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ferumoxytol.

How is ferumoxytol given (Feraheme)?

Ferumoxytol is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

You will be watched closely for at least 30 minutes after receiving ferumoxytol, to make sure you do not have an allergic reaction to the medication.

Ferumoxytol is usually given as a single injection followed by a second injection 3 to 8 days later.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with ferumoxytol. Visit your doctor regularly.

Ferumoxytol can cause unusual results with magnetic resonance imaging (MRI) tests for up to 3 months after you receive this medication. Tell any doctor who treats you that you have received a ferumoxytol injection within the past 3 months.

Ferumoxytol will not affect other types of X-rays, CT scans, ultrasounds, or nuclear radiation imaging.

Side Effects Centers
  • Feraheme

Patient Detailed Avoid Taking

What happens if I miss a dose (Feraheme)?

Call your doctor for instructions if you miss an appointment for your ferumoxytol injection.

What happens if I overdose (Feraheme)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using ferumoxytol (Feraheme)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Do not take any vitamin or mineral supplements that your doctor has not prescribed or recommended.

What other drugs will affect ferumoxytol (Feraheme)?

Tell your doctor if you are also taking an oral iron supplement (including ferrous gluconate, ferrous fumarate, or ferrous sulfate). Treatment with ferumoxytol can make it harder for your body to absorb iron supplements taken by mouth.

There may be other drugs that can interact with ferumoxytol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ferumoxytol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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