Feraheme

What is Feraheme and how is it used?

Feraheme is a prescription medicine used to treat iron deficiency anemia in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron or
• chronic kidney disease (CKD)

It is not known if Feraheme is safe and effective in children less than 18 years of age.

What are the possible side effects of Feraheme?

Feraheme can cause serious side effects, including:

• Low blood pressure (hypotension) is a common side effect of Feraheme and can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each Feraheme infusion.
• Iron overload. Your healthcare provider will do blood tests to check your iron levels during treatment with Feraheme.

The most common side effects of Feraheme include: diarrhea, headache, nausea, dizziness, constipation, and swelling of your legs, feet, arms, or hands.

These are not all of the possible side effects of Feraheme. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Feraheme may cause serious side effects including:

• Serious allergic reactions that can lead to death. Serious allergic reactions have happened in people after receiving the first dose of Feraheme or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to Feraheme. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms:
  • rash
  • itching
  • dizziness or lightheadedness
  • swelling of the tongue or throat
  • wheezing or trouble breathing

DESCRIPTION

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.

INDICATIONS

Feraheme 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).

DOSAGE AND 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 as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Feraheme does not contain antimicrobial preservatives. Discard unused portion. Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 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 (2-8° C) for up to 48 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 infusion. 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 infusion.

Allow at least 30 minutes between administration of Feraheme 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.

HOW SUPPLIED

Dosage Forms And Strengths

Feraheme Injection is available in single-dose vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL).

Storage And Handling

Feraheme is available in single-dose vials in the following package sizes (Table 6).

Table 6: 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: Feb 2018

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

• Serious Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Hypotension [see WARNINGS AND PRECAUTIONS]
• Iron Overload [see WARNINGS AND PRECAUTIONS]
• Magnetic Resonance (MR) Imaging Test Interference [see WARNINGS AND PRECAUTIONS]

Clinical Trial 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 Feraheme. 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 Feraheme 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 Feraheme was studied in a randomized, multicenter, double-blind clinical trial in patients with IDA (IDA Trial 3), [see Clinical Studies]. In this trial, patients were randomized to two intravenous infusions of 510 mg (1.02 g) of Feraheme (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 Feraheme 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 Feraheme-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 Feraheme and reported by ≥1% of Feraheme-treated patients in IDA Trial 3 are listed in Table 1.

Table 1: Adverse Reactions to Feraheme Reported in ≥1% of IDA Patients in IDA Trial 3

Adverse Reactions	Feraheme 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 Feraheme-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], patients were randomized to: two injections (rapid intravenous injection - prior method of administration no longer approved) of 510 mg of Feraheme (n=1,014), placebo (n=200), or five injections/infusions of 200 mg of iron sucrose (n=199). 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 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 Feraheme-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 Feraheme. Adverse reactions following this repeat Feraheme 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], 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 CKD randomized clinical trials are listed in Table 2 . Diarrhea (4%), constipation (2.1%) and hypertension (1%) have also been reported in Ferahemetreated patients.

Table 2: Adverse Reactions to Feraheme Reported in ≥1% of Patients with IDA and CKD Trials 1, 2 and 3

Adverse Reactions	Feraheme 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 Feraheme-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 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.

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 Feraheme: fatal, lifethreatening, and serious 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 usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.

DRUG INTERACTIONS

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

WARNINGS

Included as part of the "PRECAUTIONS" Section

PRECAUTIONS

Serious Hypersensitivity Reactions

Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme dose was tolerated.

Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients.

Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion [see ADVERSE REACTIONS].

In a clinical study in patients with IDA, regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of subjects receiving Feraheme administered as intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions.

In clinical studies predominantly in patients with IDA and CKD, serious hypersensitivity reactions were reported in 0.2% (4/1,806) of subjects receiving Feraheme (administered as a rapid intravenous injection – prior method of administration no longer approved). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.5% (63/1,806) of these subjects.

In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes [see BOX WARNING, ADVERSE REACTIONS and Use In Specific Populations].

Hypotension

Feraheme may cause clinically significant hypotension.

In a clinical study with Feraheme in patients with IDA, regardless of etiology, moderate hypotension was reported in 0.2% (2/997) of subjects receiving Feraheme administered as intravenous infusion over at least 15 minutes.

In clinical studies in patients with IDA and CKD, hypotension was reported in 1.9% (35/1,806) of subjects, including three patients with serious hypotensive reactions, who had received Feraheme as a rapid intravenous injection (prior method of administration no longer approved).

Hypotension has also been reported in the post-marketing experience [see ADVERSE REACTIONS]. Monitor patients for signs and symptoms of hypotension following each Feraheme administration [see DOSAGE AND ADMINISTRATION and Serious Hypersensitivity Reactions].

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 Test Interference

Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Conduct anticipated MR imaging studies 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.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).

Prior History Of Allergies To Parenteral Iron Products

Question patients regarding any prior history of allergies to parenteral iron products [see WARNINGS AND PRECAUTIONS].

Hypersensitivity Reactions

Advise patients to immediately report any symptoms of hypersensitivity that may develop during and following Feraheme administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see WARNINGS AND PRECAUTIONS].

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. In a pre and postnatal development study in rats, intravenous administration of ferumoxytol from gestation day 6 until lactation day 20 at doses up to 60 mg/kg/day (approximately 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person) had no effect on maternal delivery or numbers of liveborn offspring. Male offspring (F1) of pregnant rats (F0) administered ferumoxytol at a dose of 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence. Female offspring (F1) of pregnant rats (F0) administered ferumoxytol at doses of 30 mg/kg/day or 60 mg/kg/day had delayed sexual maturation and decreased reproductive competence. Doses of 30 mg/kg/day and 60 mg/kg/day are approximately 2 and 3 times the daily human dose based on body surface area comparisons assuming a 60-kg person, respectively.

Use In Specific Populations

Pregnancy

Risk Summary

Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy (see Clinical Considerations). In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose.

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 defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Untreated iron deficiency anemia (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.

Data

Animal Data

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 soft tissue fetal malformations and decreased fetal weights.

Lactation

Risk Summary

There are no data on the presence of ferumoxytol in human milk, the effects on the breastfed child, or the effects on milk production. Ferumoxytol has been detected in the milk of lactating rats. However, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Feraheme and any potential adverse effects on the breastfed child from Feraheme or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of Feraheme in pediatric patients (less than 18 years old) have not been established.

Geriatric Use

In controlled clinical trials, 833 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. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes. The potential risks and benefits of Feraheme administration should be carefully considered in these patients [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and Clinical Studies].

OVERDOSE

Limited 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]. Feraheme is not removed by hemodialysis.

CONTRAINDICATIONS

Feraheme is contraindicated in patients with:

• Known hypersensitivity to Feraheme or any of its components [see WARNINGS AND PRECAUTIONS]
• History of allergic reaction to any intravenous iron product [see WARNINGS AND PRECAUTIONS]

INDICATIONS

Feraheme 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).

DOSAGE AND 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 as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Feraheme does not contain antimicrobial preservatives. Discard unused portion. Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 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 (2-8° C) for up to 48 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 infusion. 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 infusion.

Allow at least 30 minutes between administration of Feraheme 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.

HOW SUPPLIED

Dosage Forms And Strengths

Feraheme Injection is available in single-dose vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL).

Storage And Handling

Feraheme is available in single-dose vials in the following package sizes (Table 6).

Table 6: 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: Feb 2018

PATIENT INFORMATION

Feraheme
(FER-uh-heem)
(ferumoxytol injection)

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

Feraheme may cause serious side effects including:

• Serious allergic reactions that can lead to death. Serious allergic reactions have happened in people after receiving the first dose of Feraheme or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to Feraheme. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms:
  • rash
  • itching
  • dizziness or lightheadedness
  • swelling of the tongue or throat
  • wheezing or trouble breathing

See “What are the possible side effects of Feraheme?” for more information about side effects.

What is Feraheme?

Feraheme is a prescription medicine used to treat iron deficiency anemia in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron or
• chronic kidney disease (CKD)

It is not known if Feraheme is safe and effective in children less than 18 years of age.

Who should not receive Feraheme?

Do not receive Feraheme if you:

• are allergic to Feraheme or any of the ingredients in Feraheme. See the end of this leaflet for a complete list of ingredients in Feraheme.
• have had an allergic reaction to any iron medicine given into your vein by intravenous (IV) infusion.

Before receiving Feraheme, tell your healthcare provider about all of your medical conditions, including if you:

• have allergies to many different medicines
• have iron overload
• have low blood pressure (hypotension).
• are pregnant or plan to become pregnant. It is not known if Feraheme will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Feraheme passes into your breast milk. You and your healthcare provider should decide if you will receive Feraheme or breastfeed.

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 Feraheme?

• Feraheme will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive Feraheme in 2 doses 3 to 8 days apart.
• Your healthcare provider will watch you during and for at least 30 minutes after you receive Feraheme.

What are the possible side effects of Feraheme?

Feraheme can cause serious side effects, including:

• See “What is the most important information I should know about Feraheme?”
• Low blood pressure (hypotension) is a common side effect of Feraheme and can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each Feraheme infusion.
• Iron overload. Your healthcare provider will do blood tests to check your iron levels during treatment with Feraheme.

The most common side effects of Feraheme include: diarrhea, headache, nausea, dizziness, constipation, and swelling of your legs, feet, arms, or hands.

These are not all of the possible side effects of Feraheme. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Feraheme.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Feraheme that is written for health professionals.

What are the ingredients in Feraheme?

Active ingredient: ferumoxytol

Inactive ingredient: mannitol

This Patient Information has been approved by the U.S. Food and Drug Administration.