Ivacaftor
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Ivacaftor is a cystic fibrosis transmembrane conductance regulator that is FDA approved for the treatment of cystic fibrosis. Common adverse reactions include headache, oropharyngeal pain, upper respiratory tract infection, nasal congestion, abdominal pain, nasopharyngitis, diarrhea, rash, nausea, and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Ivacaftor 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 Ivacaftor in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ivacaftor in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ivacaftor 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 Ivacaftor in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ivacaftor in pediatric patients.
Contraindications
There is limited information regarding Ivacaftor Contraindications in the drug label.
Warnings
There is limited information regarding Ivacaftor Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ivacaftor Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ivacaftor Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ivacaftor Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ivacaftor in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ivacaftor in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ivacaftor during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ivacaftor in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ivacaftor in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ivacaftor in geriatric settings.
Gender
There is no FDA guidance on the use of Ivacaftor with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ivacaftor with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ivacaftor in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ivacaftor in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ivacaftor in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ivacaftor in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ivacaftor Administration in the drug label.
Monitoring
There is limited information regarding Ivacaftor Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ivacaftor and IV administrations.
Overdosage
There is limited information regarding Ivacaftor 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 Ivacaftor Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ivacaftor Mechanism of Action in the drug label.
Structure
There is limited information regarding Ivacaftor Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ivacaftor Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ivacaftor Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ivacaftor Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ivacaftor Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ivacaftor How Supplied in the drug label.
Storage
There is limited information regarding Ivacaftor 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 Ivacaftor Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ivacaftor 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 Ivacaftor Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ivacaftor 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.