All Names： sonidegib，Odomzo
Indications：basal cell carcinoma (BCC)
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INDICATIONS AND USAGE
ODOMZO (sonidegib) is indicated 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.
Important Safety Information
Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO.
The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity.
Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients.
If a dose of ODOMZO is missed, resume dosing with the next scheduled dose.
Muscle Problems. Muscle spasms and muscle pain are common with ODOMZO, but can also sometimes be symptoms of serious muscle problems. ODOMZO can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment with ODOMZO.
Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking ODOMZO, during treatment, and if you develop muscle problems.
The most common side effects of ODOMZO include:
change in taste
stomach area (abdominal) pain
ODOMZO can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.
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