ferumoxytol (Rx)

1-10%

Headache (1.8-3.4%)

Nausea (1.8-3.1%)

Dizziness (1.5-2.6%)

Hypotension (2.5%)

Peripheral edema (2%)

Edema (1.5%)

Vomiting (1.5%)

Fatigue (1.5%)

Abdominal pain (1.3%)

Chest pain (1.3%)

Cough (1.3%)

Pruritus (1.2%)

Pyrexia (1%)

Diarrhea (1%)

Back pain (1%)

Muscle spasms (1%)

Dyspnea (1%)

Rash (1%)

<1%

Hypotension (0.4%)

Chest pain (0.2-0.3%)

Arthralgia (0.3%)

Dyspnea (0.3%)

Flushing (0.2%)

Chest discomfort (0.2%)

Nausea (0.2%)

Back pain (0.2%)

Dizziness (0.2%)

Headache (0.2%)

Frequency Not Defined

Life-threatening anaphylactic/anaphylactoid reactions

Cardiac/cardiorespiratory arrest

Clinically significant hypotension

Loss of consciousness

Unresponsiveness

Tachycardia/rhythm abnormalities

Angioedema

Ischemic myocardial events

Congestive heart failure

Pulse absent

Cyanosis

Syncope

Postmarketing Reports

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

Acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of hypersensitivity reactions

Congestive heart failure

Absent pulse

Cyanosis

Contraindications

Known hypersensitivity to ferumoxytol or any of its components

History of allergic reaction to any intravenous iron product

Cautions

May cause life-threatening hypersensitivity reactions such as anaphylaxis and/or anaphylactoid reactions (see Black Box Warnings)

Elderly patients (>65 years) or patients with multiple comorbidities who experience a serious hypersensitivity reaction due to ferumoxytol may have more severe outcomes

Risk of anaphylaxis increases in patients with multiple drug allergies

Anaphylactic reactions presenting with cardiac/cardiorespiratory arrest, syncope, hypotension and unresponsiveness have been identified in post-marketing reports

Clinically significant hypotension may occur; in a clinical study with ferumoxytol in patients with IDA, regardless of etiology, moderate hypotension was reported in 0.2% (2/997) of subjects

Excessive therapy with IV iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis; monitor the hematologic response during IV iron therapy; do not administer ferumoxytol to patients with iron overload; within 24 hr following administration, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring iron in the ferumoxytol

Monitor hematologic responses during therapy, do not administer if evidence of iron overload

Can alter magnetic resonance imaging (MRI) studies

Pregnancy

Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes

In animal studies, 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

Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia as well as risks to the fetus associated with maternal severe hypersensitivity reactions

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products, which may cause fetal bradycardia, especially during second and third trimester

Lactation

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

Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ferumoxytol and any potential adverse effects on the breastfed child from ferumoxytol or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Iron-carbohydrate complex released within macrophage vesicles; either enters intracellular iron storage (eg, ferritin) or transferred to plasma transferrin for transport to erythroid precursor cells for hemoglobin incorporation

Absorption

Peak plasma concentration: 206 mcg/mL

Peak plasma time: 0.32 hr

Distribution

Vd: 3.16 L (two 510 mg-dose administered IV within 24 hr)

Excretion

Half-life: 15 hr

Clearance: 3.16 L

IV Compatibility

0.9% NaCl

D5W

IV Preparation

Dilute dose in 50-200 mL 0.9% NaCl or D5W

Inspect visually for particulate matter and discoloration prior to administration

IV Administration

Should only be administered as a diluted IV infusion over a minimum period of 15 minutes

Administer while the patient is in a reclined or semi-reclined position

Allow at least 30 minutes between administration of ferumoxytol and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension (eg, chemotherapeutic agents, monoclonal antibodies)

Diluted solutions immediately but may be stored at controlled room temperature (25°C) for up to 4 hours or refrigerated (2-8°C) for up to 48 hours

Storage

Unused vials: Store at room temperature (20-25°C [68-77°F]); excursions permitted to 15-30°C (5-86°F)

Diluted solutions: Stored at room temperature (25°C) for up to 4 hr or refrigerated (2-8°C) for up to 48 hr