Ferumoxytol: Difference between revisions

Ferumoxytol
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 15:09, 24 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

WARNING:

See full prescribing information for complete Boxed Warning.

RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS:

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [SEE WARNINGS AND PRECAUTIONS (5.1)]. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [SEE WARNINGS AND PRECAUTIONS (5.1)].

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated

Overview

Ferumoxytol is a iron replacement product that is FDA approved for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD)

Dosage

The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours.

The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme infusion. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme infusion.

Allow at least 30 minutes between administration of Feraheme and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ferumoxytol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ferumoxytol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and efficacy not established in pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ferumoxytol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ferumoxytol in pediatric patients.

Contraindications

Condition1

Warnings

WARNING:

See full prescribing information for complete Boxed Warning.

RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS:

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [SEE WARNINGS AND PRECAUTIONS (5.1)]. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [SEE WARNINGS AND PRECAUTIONS (5.1)].

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ferumoxytol in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ferumoxytol in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ferumoxytol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ferumoxytol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ferumoxytol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ferumoxytol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ferumoxytol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ferumoxytol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ferumoxytol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ferumoxytol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ferumoxytol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ferumoxytol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ferumoxytol in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Ferumoxytol in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Ferumoxytol in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ferumoxytol in the drug label.

Pharmacology

There is limited information regarding Ferumoxytol Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ferumoxytol01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ferumoxytol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ferumoxytol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ferumoxytol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ferumoxytol in the drug label.

How Supplied

Storage

There is limited information regarding Ferumoxytol Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ferumoxytol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ferumoxytol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ferumoxytol in the drug label.

Precautions with Alcohol

Alcohol-Ferumoxytol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

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[1]

[2]

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