Posted on April 24th, 2015 by
Class: Biological Therapy
Generic Name: Nivolumab
Trade Name: Opdivo®
For which conditions is this drug approved? Opdivo is approved to treat melanoma that: a) can’t be removed by surgery; or b) metastatic melanoma that’s progressed after treatment with Yervoy® (ipilimumab) or, if BRAF V600 mutation positive, progressed after treatment with a BRAF inhibitor. Opdivo is also approved to treat a type of advanced stage lung cancer (squamous non-small cell lung cancer [NSCLC]) that has spread or grown after treatment with platinum-based chemotherapy and advanced renal cell carcinoma that has progressed after anti-angiogenic treatment. Furthermore, Opdivo is approved to treat classical Hodgkin’s lymphoma (cHL) that has progressed following a hematopoietic stem cell transplant (HSCT) which has been followed by the chemotherapy/biologic drug Adcetris®.
What is the mechanism of action? Opdivo works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer.
How is Opdivo typically given (administered)? Opdivo is given as an intravenous infusion over 60 minutes usually every two weeks.
How are patients typically monitored? Opdivo is designed to work with your immune system to treat melanoma, lung cancer, kidney cancer, or blood cancer, but it can also cause your immune system to attack normal organs and tissues. Your doctor will monitor you (using blood tests and exams) for these complications: lung, intestinal, liver, kidney, and thyroid problems.
What are the most common side effects of treatment with Opdivo?
What are the less common but serious side effects of treatment with Opdivo?
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?
Tell your doctor about all of your medical conditions, particularly the following:
When should patients notify their physician? Contact your doctor if you experience any of 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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