Dr. Saltiel received his Pharm.D. from the University of California, San Francisco, in 1980, following undergraduate work at UCLA. At UCSF, he was the recipient of the Outstanding Service Award and the Bowl of Hygeia Award. He completed a residency in clinical pharmacy practice at the University of Illinois, in Chicago.
Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.
June 17, 2005 - The Food and Drug Administration (FDA) approved new
labeling for gefitinib
(Iressa). AstraZeneca will distribute the drug under restrictions as part of the
Iressa Access Program.
Prescriptions for Iressa will be limited the following patient populations:
patients currently receiving and benefiting from Iressa;
patients who have previously received and benefited from Iressa; and
previously enrolled patients or new patients in non-Investigational New
Drug Application (non-IND) clinical trials approved by an IRB (Institutional
Review Board) prior to June 17, 2005.
DRUG CLASS AND MECHANISM: Gefitinib is a drug that is used to treat several types of lung cancer. It works by preventing lung cancer cells from growing and multiplying.
Many cells, including cancer cells, have receptors on their surfaces for epidermal growth factor (EGF), a protein that is normally produced by the body and that promotes the growth and multiplication of cells. When EGF attaches to epidermal growth factor receptors (EGFRs), it causes an enzyme called tyrosine kinase to become active within the cells. Tyrosine kinase triggers chemical processes that cause the cells, including cancer cells, to grow, multiply, and spread. Gefitinib attaches to EGFRs and thereby blocks the attachment of EGF and the activation of tyrosine kinase. This mechanism for stopping cancer cells from growing and multiplying is very different from the mechanisms of chemotherapy and hormonal therapy. Gefitinib was approved by the FDA in May of 2003.
PRESCRIPTION: Yes .
GENERIC AVAILABLE: No.
PREPARATIONS: Clear capsules of 50 mg.
STORAGE: Capsules should be stored at room temperature, 15-30°C (59-86°F).
PRESCRIBED FOR: Gefitinib is used alone (monotherapy) for the treatment of patients with a certain type of lung cancer (non-small cell lung cancer or NSCLC) that has not responded to chemotherapy.
Lung cancer is the second most common cancer in both men and women and is the leading cause of deaths from cancer in the US. Lung cancer is divided into two major types: small cell lung cancer and NSCLC. NSCLC is the most common type, accounting for almost 80% of lung cancers. There are five subtypes of NSCLC, each of which is made up of different kinds of cancer cells. The cancer cells of each type differ in size, shape, and chemical make-up, and grow and spread in different ways. The three most common types of NSCLC are squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. About one in ten people with NSCLC who receive gefitinib will have a substantial reduction in the size of their cancers, even after other drugs have failed; however, the cancer is not cured.
DOSING: Gefitinib is taken by mouth. The dose is 250 mg once daily. The dose is the same for men or women of any age or weight, and gefitinib can be taken with or without food
DRUG INTERACTIONS: Gefitinib may increase the blood-thinning effects of warfarin (Coumadin) and increase the risk of bleeding. Therefore, patients receiving gefitinib and warfarin at the same time should have more frequent testing of the "thinness" of their blood. Patients who receive drugs that increase an enzyme in the liver called CYP 3A4 that destroys gefitinib (e.g., rifampin or phenytoin (Dilantin) may need a higher dose of gefitinib to maintain the effectiveness of gefitinib. Similarly, patients who receive drugs that reduce CYP 3A4, e.g.,
ketoconazole (Nizoral), itraconazole (Sporanox), fluconazole (Diflucan), erythromycin, clarithromycin (Biaxin), ritonavir (Norvir), nelfinavir (Viracept), indinavir (Crixivan), nefazodone (Serzone), as well as grapefruit juice, may need a lower dose of gefitinib to prevent side effects from increased levels of gefitinib.
Lung cancer kills more men and women than any other form of cancer. Eight out of 10 lung cancers are due
to tobacco smoke. Lung cancers are classified as either small cell or non-small
cell cancers.
Cancer is a disease caused by an abnormal growth of cells, also called malignancy. It is a group of 100 different diseases, and is not contagious. Cancer can be treated through chemotherapy, a treatment of drugs that destroy cancer cells.
Though it's difficult to say why some people develop cancer while others don't, research shows that certain risk factors increase a person's odds of developing cancer. These risk factors include growing older, family history of cancer, diet, alcohol and tobacco use, and exposure to sunlight, ionizing radiation, certain chemicals, and some viruses and bacteria.
Cancer is the uncontrolled growth of abnormal cells anywhere
in a body. The abnormal cells are termed cancer cells, malignant cells, or tumor
cells. Many cancers and the abnormal cells that compose the cancer tissue are
further identified by the name of the tissue that the abnormal cells originated
from (for example, breast cancer, lung cancer, colon cancer). Cancer is not
confined to humans; animals and other living organisms can get cancer. Below is
a schematic that shows normal cell division and how when a cell is damaged or
altered without repair to its system, the cell usually dies. Also shown is what
can occur when such damaged or unrepaired cells do not die and become cancer
cells and proliferate with uncontrolled growth; a mass of cancer cells develop.
Frequently, cancer cells can break away from this original mass of cells, travel
through the blood and lymph systems, and lodge in other organs where they can
again repeat the ...
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