Posted on January 7th, 2016 by
Class: Biological therapy
Generic Name: Obinutuzumab
Trade Name: Gazyva®
For which conditions is this drug approved? Gazyva is approved for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with the chemotherapy drug Leukeran® (chlorambucil). Gazyva is also indicated for patients with follicular lymphoma (FL) in combination with Treanda® (bendamustine), followed by therapy with Gazyva alone. This regimen is for adults with FL who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
What is the mechanism of action? Gazyva works by helping certain cells in the immune system attack cancer cells. Specifically, by targeting an antibody known as CD20, which is found on B-cells, Gazyva helps the immune system recognize and destroy cancer cells.
How is Gazyva typically given (administered)? Gazyva is given as an intravenous (into the vein) infusion over the course of several cycles.
How are patients typically monitored? During treatment with Gazyva, your doctor will watch for the following:
What are the common (occur in 30% or more of patients) side effects of treatment with Gazyva?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Gazyva?
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?
Tell your doctor if you experience the following:
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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