Simeprevir
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
Simeprevir is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Simeprevir FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Simeprevir in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Simeprevir in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Simeprevir FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Simeprevir in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Simeprevir in pediatric patients.
Contraindications
There is limited information regarding Simeprevir Contraindications in the drug label.
Warnings
There is limited information regarding Simeprevir Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Simeprevir Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Simeprevir Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Simeprevir Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Simeprevir in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Simeprevir in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Simeprevir during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Simeprevir in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Simeprevir in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Simeprevir in geriatric settings.
Gender
There is no FDA guidance on the use of Simeprevir with respect to specific gender populations.
Race
There is no FDA guidance on the use of Simeprevir with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Simeprevir in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Simeprevir in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Simeprevir in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Simeprevir in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Simeprevir Administration in the drug label.
Monitoring
There is limited information regarding Simeprevir Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Simeprevir and IV administrations.
Overdosage
There is limited information regarding Simeprevir 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 Simeprevir Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Simeprevir Mechanism of Action in the drug label.
Structure
There is limited information regarding Simeprevir Structure in the drug label.
Pharmacodynamics
There is limited information regarding Simeprevir Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Simeprevir Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Simeprevir Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Simeprevir Clinical Studies in the drug label.
How Supplied
There is limited information regarding Simeprevir How Supplied in the drug label.
Storage
There is limited information regarding Simeprevir 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 Simeprevir Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Simeprevir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Simeprevir Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Simeprevir 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.