Treatment Option In Metastatic Breast Cancer

Sunday, March 1, 2009

Treatment Option In Metastatic Breast Cancer (NAPSA)—Breast canceris the second leading cause of cancer deaths in women in the United States. Metastatic breast canceris the most advanced stage of breast cancer. For more than 60 years, chemotherapy has been, and continues to be, one of the founda- tions in the treatment of cancer. Most breast cancer patients will receive chemotherapy at some time during the course of their disease. However, resistance to chemotherapy is a major cause of treatment failure in patients with metastatic breast cancer. Drug resistance is associated with >90 percent of treatment failures in patients with metastatic breast cancer. In October 2007, the U.S. Food and Drug Administration (FDA) granted approval of the first epothilone chemotherapy, IXEMPRA”(ixabepilone), as a monotherapy for the treatment of patients with metastatic or locally advanced breast cancer resistant or refractory to anthracyclines, taxanes, and capecitabine. Anthracycline resistance is defined as progression while on therapy or within six monthsin the adjuvant setting or three months in the metastatic setting. Taxane resis- tance is defined as progression while on therapy or within 12 months in the adjuvant setting or four monthsin the metastatic setting. IXEMPRAwasalso granted approval in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose can- cer is taxane resistant and for whom further anthracycline therapy is contraindicated. Your healthcare provider should do blood tests to check your liver function before receiving IXEMPRAand as needed while receiving IXEMPRA. If blood tests show that you have liver problems, do not receive injections of IXEMPRAalong with the medicine capecitabine. With liver problems, taking these medicines together could increase your chance of serious infection and death due to a very low white blood cell count (neutropenia). @ The most commonside effects with IXEMPRA used alone or with capecitabine may include: tiredness; loss of appetite; disorders of toenails and fingernails; hair loss; fever; decreased red blood cells (anemia); joint and muscle pain; headache; decreased platelets (thrombocytopenia); nausea, vomiting, diarrhea, constipation, and abdominal pain; sores on thelip, in the mouth and esophagus; tender, red palms andsoles of feet (handfoot syndrome) that look like a sunburn, the skin may become dry and peel or feel numbandtingle. “Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options,” said Linda Vahdat, M_D., Associate Professor of Clinical Medicine, Director Breast Cancer Research Program, Weill Cornell Medical Center. “The approval of IXEMPRA means that we have an important option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies.” ween nee eee nee eee eee eee WOE ee eee eee eee eee eee eee eee eee eee Important Safety Information Indications and Usage: IXEMPRA™(ixabepilone} is a prescription medicine usedto treat breast cancer, when certain other medicines have not worked or no longer work. IXEMPRA is used alone or with another cancer medicine called capecitabine. Important Safety Information about IXKEMPRA Your healtheare provider should do blood tests to check your liver function before receiving IXEMPRA andas needed while receiving IXEMPRA.If blood tests show that you haveliver problems, do not receive injections of IXEMPRA along with the medicine capecitabine. With liver problems, taking these medicines together could increase your chanceof serious infection and death due to a very low white blood cell count (neutropenia). You should not receive IXEMPRA (ixabepilone),if you are: * Allergic to a medicine that i a hy EL’or pol: i castor oil. * Have low white blood ceil or platelet counts. Before you receive treatment with IXEMPRA,a medicinegiven by injection directly into your vein (intravenous infusion), you should tell your healthcare provider aboutall your medical conditions, includingif you: * Haveliver problems. * Have heart problemsor a history ofheart problems. * Have had an allergic reaction to IXEMPRA. To lower the chance of an allergic reaction, you will receive other medicines about 1 hour before each dose ofIXEMPRA. * Are pregnant or plan to become pregnant. IXEMPRA may harm your unborn baby. * Are breast-feeding. It is not known ifIXEMPRA passes into breast milk. * Take any medicines, including prescription and non-prescription medicines, vitamins and herbal supplements, including St. John’s Wort. IXEMPRA and certain other medicines may affect each other causing side effects. * Have diabetes. * Have had numbness, tingling, or burning in the hands orfeet (neuropathy) Things to avoid while taking IXEMPRA: * IXEMPRA contains alcohol and may cause dizzt or di Avoid that may be dangerous, such as driving or operating machinery. * Do not drink grapefruit juice because it may cause you to have too much IXEMPRA in your blood which can lead to side effects. IXEMPRA maycauseseriousside effects. Tell your healthcare provider if you have the following: * Numbness, tingling, or burning in the handsor feet (neuropathy). These symptoms may be new or get worse and often occur early during treatment. Your dose ofIXEMPRA may need to be decreased, stopped until your symptoms get better, or totally stopped. * White blood cells help protect the body fram infections caused by bacteria. Ifyou get a fever or infection when your white blood ceils are very low, you can become seriously Ul and die. Symptoms may include, fever (temperature over 100.5), chills, cough, burning, or pain when you urinate. You may need treatmentin the hospital with antibiotic medicines. * Severe allergic reactions can occur and in rare cases cause death. Allergic reactions are most likely to occur when IXEMPRA is being injected. You may experience liching, hives, rash, flushed face, sudden swelling offace, throat or tongue, chest tightness, trouble breathing, feel dizzy or faint, feel your heart beating (palpitations). * Chest pain, difficulty breathing, palpitations, or unusual weight gain can be caused by decreased blood flow to the heart, problems with heart function and abnormal heart beat. The most commonside effects with IXEMPRA used alone or with capecitabine may include:tiredness; loss ofappetite; disorders of toenails and fingernails; hair loss; fever; decreased red blood cells (anemia); joint and muscle pain; headache; decreased platelets (throm boc: ia); nausea, ing, diarrhea, ipation, and pain; sores on the lip, in the mouth and esophagus; ten der, red palms and soles offeet (hand-foot syndrome)that look like a sunburn, the skin may become dry and peelor feel numb and tingle. Ifyou have any questions about your health or medicines, talk to your healthcare provider. Please see accompanying full prescribing information including boxed WARNINGregardingliver disease. *Cremophoris a registered trademark ofBASF AG. Brought to you by Bristol-Myers Squibb.

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