Fosaprepitant

Fosaprepitant
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

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

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• EMEND® for Injection is a substance P/neurokinin-1 (NK1) receptor antagonist indicated in adults for use in combination with other antiemetic agents for the:

• Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.

• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Limitations of Use

• EMEND for Injection has not been studied for the treatment of established nausea and vomiting.

• Chronic continuous administration is not recommended

Dosage

Prevention of Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy (HEC)

EMEND for Injection 150 mg (Single Dose Regimen of EMEND):

• EMEND for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. No capsules of EMEND are administered on Days 2 and 3. EMEND for Injection should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 1. The recommended dosage of dexamethasone with EMEND for Injection 150 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 115 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

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This image is provided by the National Library of Medicine.

EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

• EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 2. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

• Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

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This image is provided by the National Library of Medicine.

Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy (MEC)

EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

• EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 3. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

• Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

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This image is provided by the National Library of Medicine.

Preparation of EMEND for Injection

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This image is provided by the National Library of Medicine.

• The reconstituted final drug solution is stable for 24 hours at ambient room temperature (at or below 25°C).

• Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

• Caution: EMEND for Injection should not be mixed or reconstituted with solutions for which physical and chemical compatibility have not been established. EMEND for Injection is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Lactated Ringer's Solution and Hartmann's Solution.

DOSAGE FORMS AND STRENGTHS

• One 150-mg single dose glass vial: White to off-white lyophilized solid (Sterile lyophilized powder for intravenous use only after reconstitution and dilution).

• One 115-mg single dose glass vial: White to off-white lyophilized solid (Sterile lyophilized powder for intravenous use only after reconstitution and dilution).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Fosaprepitant in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Fosaprepitant Contraindications in the drug label.

Warnings

There is limited information regarding Fosaprepitant Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fosaprepitant 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 Fosaprepitant 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 Fosaprepitant in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Fosaprepitant01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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