Rolapitant
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Rolapitant is a substance P/neurokinin 1 (NK1) receptor antagonist that is FDA approved for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Common adverse reactions include neutropenia, hiccups, decreased appetite and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Rolapitant is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
Dosage
Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
The recommended dosage of rolapitant in adults in combination with a 5-HT3 receptor antagonist and dexamethasone is shown in TABLE 1. There is no drug interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required. Administer a dexamethasone dose of 20 mg on Day 1.
Administer rolapitant prior to the initiation of each chemotherapy cycle, but at no less than 2 week intervals.
Administer rolapitant without regards to meals.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Rolapitant in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rolapitant in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and efficacy of rolapitant have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Rolapitant in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rolapitant in pediatric patients.
Contraindications
There is limited information regarding Rolapitant Contraindications in the drug label.
Warnings
There is limited information regarding Rolapitant Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Rolapitant Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Rolapitant Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Rolapitant Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Rolapitant in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rolapitant in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rolapitant during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Rolapitant in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Rolapitant in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Rolapitant in geriatric settings.
Gender
There is no FDA guidance on the use of Rolapitant with respect to specific gender populations.
Race
There is no FDA guidance on the use of Rolapitant with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rolapitant in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rolapitant in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Rolapitant in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Rolapitant in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Rolapitant Administration in the drug label.
Monitoring
There is limited information regarding Rolapitant Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Rolapitant and IV administrations.
Overdosage
There is limited information regarding Rolapitant overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Rolapitant Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Rolapitant Mechanism of Action in the drug label.
Structure
There is limited information regarding Rolapitant Structure in the drug label.
Pharmacodynamics
There is limited information regarding Rolapitant Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Rolapitant Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Rolapitant Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Rolapitant Clinical Studies in the drug label.
How Supplied
There is limited information regarding Rolapitant How Supplied in the drug label.
Storage
There is limited information regarding Rolapitant 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 Rolapitant Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Rolapitant interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
VARUBI™
Look-Alike Drug Names
There is limited information regarding Rolapitant Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.