Ferumoxytol Injection

Unless your doctor tells you otherwise, continue your normal diet.

Ferumoxytol injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• nausea
• vomiting
• stomach pain
• headache
• swelling of the hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience the following symptom or those symptoms listed in the IMPORTANT WARNINGS section, call your doctor immediately or get emergency medical treatment:

• chest pain

Ferumoxytol injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure and order certain lab tests to check your body's response to ferumoxytol injection.

Before having any magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body), tell your doctor and the testing personnel that you are receiving ferumoxytol injection. Ferumoxytol injection may affect MRI studies for up to 3 months after your last dose of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• 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.

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.

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

Feraheme administration 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

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.

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, life-threatening, 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.

Read the entire FDA prescribing information for Feraheme (Ferumoxytol Injection)