Posted on April 28th, 2009 by
Generic Name: Vorinostat (voe-RIN-oh-stat)
Trade Name: Zolinza™
For which conditions is this drug approved? Vorinostat is FDA-approved for the treatment of cutaneous T-cell lymphoma that has progressed or recurred following two systemic (full body) therapies. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Vorinostat belongs to a group of drugs called histone deacetylase (HDAC). Histone deacetylases impair structural integrity of a cell, ultimately preventing a cell from replicating.
How is vorinostat typically given (administered)? Vorinostat is administered orally, typically once per day with food. The dose may be modified if a patient cannot tolerate full doses of vorinostat. Pills or tablets of vorinostat should be swallowed whole and not opened or crushed.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with vorinostat. Typically, skin assessments will be made to monitor responses to treatment. Blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with vorinostat?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with vorinostat?
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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