Posted on November 4th, 2015 by
Class: Biological Therapy
Generic Name: Odomzo®
Trade Name: Sonidegib
For which conditions is this drug approved? Odomzo is approved for the treatment of adults with a type of skin cancer called basal cell carcinoma (BCC). Specifically, Odomzo is used in BCC that has come back following surgery or radiation or that cannot be treated with surgery or radiation.
What is the mechanism of action? Odomzo works by blocking the activity of a cell-signaling pathway known as the hedgehog pathway, which plays a role in the growth and spread of BCC.
How is Odomzo typically given (administered)? Odomzo is a pill that you’ll take by mouth once daily. Take Odomzo on an empty stomach at least one hour before or two hours after a meal.
How are patients typically monitored? Before you start taking Odomzo, your doctor will do a blood test to make sure you don’t have any muscle problems and that your kidneys are functioning normally. Your doctor will also perform these tests during treatment and if you develop muscle problems.
What are the common (occur in 30% or more of patients) side effects of treatment with Odomzo?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Odomzo?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
If you think that you or your female partner may have been exposed to Odomzo during pregnancy, talk to your doctor right away.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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