Ivacaftor

Ivacaftor
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: 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)

Cystic Fibrosis

• Dosage: One 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food. Examples of appropriate fat-containing foods include eggs, butter, peanut butter, cheese pizza,

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)

Cystic Fibrosis

• Dosage: One 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food. Examples of appropriate fat-containing foods include eggs, butter, peanut butter, cheese pizza,

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

None

Warnings

Transaminase (ALT or AST) Elevations

Elevated transaminases have been reported in patients with CF receiving KALYDECO. It is recommended that ALT and AST be assessed prior to initiating KALYDECO, every 3 months during the first year of treatment, and annually thereafter. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal (ULN). Following resolution of transaminase elevations, consider the benefits and risks of resuming KALYDECO dosing.

5.2 Concomitant Use with CYP3A Inducers Use of KALYDECO with strong CYP3A inducers, such as rifampin, substantially decreases the exposure of ivacaftor, which may reduce the therapeutic effectiveness of KALYDECO. Therefore, co-administration of KALYDECO with strong CYP3A inducers (e.g., rifampin, St. John's Wort) is not recommended [see DRUG INTERACTIONS (7.2) and CLINICAL PHARMACOLOGY (12.3)].

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.