Posted on March 16th, 2015 by
Class: Biological Therapy
Generic Name: ceritinib
Trade Name: Zykadia™
For which conditions is this drug approved? Zykadia is approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase) whose disease has worsened after taking Xalkori® (crizotinib) or cannot tolerate Xalkori.
What is the mechanism of action? Zykadia is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, Zykadia targets ALK.
How is Zykadia typically given (administered)? Zykadia is given orally (capsule) once daily at a dose of 750 mg.
How are patients typically monitored? Zykadia can cause complications involving the liver, so patients will have liver function monitored at least monthly. Patients should also be monitored for high blood sugar (hyperglycemia) and have heart rate and blood pressure checked regularly.
What are the common (occur in 30% or more of patients) side effects of treatment with Zykadia?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Zykadia?
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?
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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