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ferumoxytol (Rx)Brand and Other Names:Feraheme

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 510mg/17mL vial (ie, 30mg/mL)
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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

Safety and efficacy not established

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Adverse 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

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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

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Pregnancy & 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.

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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

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)

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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)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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