Posted on October 14th, 2010 by
Class: Biological Therapy
Generic Name: everolimus (ever-OH-li-mus)
Trade Name: Afinitor®
How is this drug used? Afinitor is FDA-approved for the treatment of advanced renal cell carcinoma (kidney cancer) among patients whose cancer has recurred or progressed following treatment with either Sutent® (sunitinib) or Nexavar® (sorafenib); for the treatment of a benign brain tumor—subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis—in children and adults who require treatment but are not candidates for surgical removal of the tumor; for the treatment of progressive, locally advanced or metastatic, pancreatic neuroendocrine tumors (PNET) that cannot be surgically removed and for adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic; for the treatment of renal angiomyolipoma (a benign kidney tumor) in people with tuberous sclerosis; and in combination with Aromasin® (exemestane) for the treatment of advanced, hormone receptor-positive, HER2-negative breast cancer in postmenopausal women who have already been treated with certain other medications.
What is the mechanism of action? Afinitor belongs to a group of drugs referred to kinase inhibitors. Afinitor inhibits the serine-threonine kinase referred to as the mammalian target of rapamycin (mTOR). MTOR is involved in cellular replication, growth, and metabolism. Inhibition of mTOR with Afinitor has demonstrated a reduction in the replication and spread of cancer cells.
How is Afinitor given (administered)? Afinitor is given orally in the form of a tablet. You should not drink grapefruit juice or eat grapefruit during treatment with Afinitor.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Afinitor. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the liver or kidneys. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the most common (occur in 30% or more of patients) side effects of treatment with Afinitor?
Among patients with advanced PNET, breast cancer, or renal cell cancer:
Among patients with SEGA:
Among patients with renal angiomyolipoma:
What are some of the less common but potentially serious side effects of treatment with Afinitor?
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 any side effects that bother you or don’t go away. Also tell 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.
Copyright © 2016 CancerConnect Last updated 08/16.
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