Applies to the following strength(s): 200 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Basal Cell Carcinoma
200 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
-This drug should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.
-Prior to treatment initiation, serum creatinine kinase (CK) levels and renal function tests should be obtained from all patients, and the pregnancy status of females of reproductive potential should be verified.
Use: 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.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
-Mild Hepatic Impairment (total bilirubin at the upper limit of normal or less and AST greater than ULN OR total bilirubin greater than 1 to 1.5 x ULN): No adjustment recommended
-Moderate and Severe Hepatic Impairment: Data not available
For the Following Conditions, Interrupt Treatment Until Resolution of Clinical Signs and Symptoms then Resume Treatment at 200 mg/day:
-Severe or intolerable musculoskeletal adverse reactions
-First occurrence of serum CK elevation between 2.5 and 10 x ULN
-Recurrent serum CK elevation between 2.5 and 5 x ULN
Permanently Discontinue Treatment for the Following Conditions:
-Serum CK elevation greater than 2.5 x ULN with worsening renal function
-Serum CK elevation greater than 10 x ULN
-Recurrent serum CK elevation greater than 5 x ULN
-Recurrent severe or intolerable musculoskeletal adverse reactions
US BOXED WARNING:
-This drug can cause embryofetal death or severe birth defects when administered to pregnant women, and is embryotoxic, fetotoxic, and teratogenic in animals.
-Females of reproductive potential should have their pregnancy status verified before treatment initiation, and be advised to use effective contraception during treatment and for at least 20 months after the last dose.
-Males should be advised of the potential risk of exposure through semen, and to use condoms during treatment and for at least 8 months after the last dose to avoid potential drug exposure in female partners who are pregnant or of reproductive potential.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-A missed dose should be skipped; treatment should be resumed with the next scheduled dose.
-Embryofetal Toxicity: Pregnancy test (before treatment initiation)
-Musculoskeletal: Baseline serum CK and creatinine levels (before treatment initiation, periodically during treatment, and as clinically indicated; at least weekly during treatment in patients with musculoskeletal adverse reactions with concurrent serum CK elevations greater than 2.5 x ULN)
-Renal: Renal function tests (before treatment initiation)
-This drug can interact with a variety of medications. Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements.
More about sonidegib
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- During Pregnancy
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- Drug class: hedgehog pathway inhibitors
Other brands: Odomzo