Sonidegib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Sonidegib is a hedgehog pathway inhibitor that is FDA approved for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Common adverse reactions include muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, and pruritus (≥10%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Sonidegib FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sonidegib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Sonidegib Contraindications in the drug label.
Warnings
There is limited information regarding Sonidegib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Sonidegib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Sonidegib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Sonidegib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sonidegib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sonidegib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sonidegib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sonidegib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sonidegib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sonidegib in geriatric settings.
Gender
There is no FDA guidance on the use of Sonidegib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sonidegib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sonidegib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sonidegib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sonidegib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sonidegib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Sonidegib Administration in the drug label.
Monitoring
There is limited information regarding Sonidegib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Sonidegib and IV administrations.
Overdosage
There is limited information regarding Sonidegib 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 Sonidegib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sonidegib Mechanism of Action in the drug label.
Structure
There is limited information regarding Sonidegib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sonidegib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sonidegib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sonidegib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sonidegib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Sonidegib How Supplied in the drug label.
Storage
There is limited information regarding Sonidegib 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 Sonidegib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sonidegib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Sonidegib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sonidegib 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.