Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 510mg/17mL vial (30mg/mL)
- Concentration expressed in terms of elemental Fe
Iron Deficiency Anemia
Indicated for iron deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron
Also, indicated for IDA in adults who have chronic kidney disease (CKD)
510 mg IV infused over 15 min once, followed by a second dose 3-8 days later
Also see Administration
MRI of Brain Tumors (Orphan)
For use in MR imaging for the management of brain tumors
Orphan indication sponsor
- Oregon Health & Science University; 3181 SW Sam Jackson Pk Road, Mailcode L603; Portland, OR 97239
Dosage Modifications
Renal impairment
Hemodialysis
- Administer dose once blood pressure stable and patient has completed at least 1 hr of hemodialysis
- Monitor for hypotension
- Not removed by hemodialysis; dose adjustment not necessary
<18 years: Safety and efficacy not established
Adverse Effects
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
Warnings
Black Box Warnings
Serious hypersensitivity/ anaphylaxis reactions
- Fatal and serious hypersensitivity reactions including anaphylaxis have occurred
- Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest
- Only administer as IV infusion over at least 15 minutes when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following infusion, including monitoring of blood pressure and pulse during and after administration
- Hypersensitivity reactions have occurred in patients in whom a previous dose was tolerated
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 & Lactation
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.Pharmacology
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
Administration
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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Feraheme intravenous - | 510 mg/17 mL (30 mg/mL) vial | ![]() | |
Feraheme intravenous - | 510 mg/17 mL (30 mg/mL) vial | ![]() |
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