Dosing and uses of Feraheme (ferumoxytol)
Adult dosage forms and strengths
IV solution
- 510mg/17mL vial (ie, 30mg/mL)
Iron Deficiency Anemia in Chronic Kidney Disease
Should only administer as intravenous infusion in 50-200 mL of 0.9% sterile sodium chloride or 5% sterile dextrose over a minimum period of 15 minutes following dilution
May readminister dose if iron deficiency anemia persists or reoccurs
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
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
Pediatric dosage forms and strengths
Safety and efficacy not established
Feraheme (ferumoxytol) adverse (side) effects
1-10%
Abdominal pain
Diarrhea
Nausea
Vomiting
Dizziness
Hypotension
Constipation
Edema
Peripheral edema
Back pain
Chest pain
Cough
Dyspnea
Headache
Muscle spasms
Pruritus
Pyrexia
Rash
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
Warnings
Black box warnings
Initial symptoms of hypersensitivity may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred
Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest
Only administer 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)
Observe for signs and symptoms of hypersensitivity for at least 30 minutes following administration; elderly patients (> 65 years of age) 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
May cause severe adverse reactions of clinically significant hypotension (monitor blood pressure during/following administration)
Monitor hematologic responses during therapy, do not administer if evidence of iron overload
Can alter magnetic resonance imaging (MRI) studies
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
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 of Feraheme (ferumoxytol)
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
Pharmacokinetics
Half-Life: 15 hr
Vd: 3.16 L
Peak Plasma Time: 0.32 hr
Peak Plasma Concentration: 206 mcg/mL
Clearance: 69.1 mL/hr
Distribution: Liver, spleen, lymph node, RBC (by 24 hr)
Excretion: Insignificant iron excretion (incorporated into heme)
Administration
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)
Storage
Store vials at room temperature (20-25°C [68-77°F]); excursions permitted to 15-30°C (5-86°F)
