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| Prescribing Information | Medication Guide | Important Safety Information | ||||||||||||
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U.S. Headquarters OfficeActelion Pharmaceuticals US, Inc.5000 Shoreline Court, Suite 200 South San Francisco, CA 94080 Tel.: 1-650-624-6900 PAH Pathways®PAH Pathways is Actelion's patient service and support program.For questions about Tracleer, insurance coverage or financial assistance, please contact PAH Pathways. Phone: 1-866-ACTELION (1-866-228-3546)—Monday—Friday, 9 am—8 pm (ET) Fax: 1-866-279-0669 (for Tracleer Enrollment and Renewal form and HIPAA form) Medical QuestionsFor medical questions about Tracleer or PAH, please call the medical information hotline at 1-866-ACTELION (1-866-228-3546).Sure Steps™ Patient SupportFor information on ongoing patient education and support, contact PAH Pathways atEnglish: 1-866-ACTELION (1-866-228-3546)—Monday—Friday, 8 am—11 pm (ET) Español: 1-877-783-7791 —lunes—viernes, 9 am—5 pm (ET) IMPORTANT SAFETY INFORMATION Because of the risks associated with Tracleer, this medication may be prescribed by your doctor only through the Tracleer Access Program. Liver damage: Tracleer can cause serious liver damage, including in rare cases liver failure and, in situations with regular liver testing, unexplained liver cirrhosis. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Call your doctor right away if you have any of these symptoms of liver problems: nausea, vomiting, fever, unusual tiredness, abdominal (stomach area) pain, or yellowing of the skin or the whites of your eyes (jaundice). Serious birth defects: Tracleer is very likely to cause serious birth defects. It is important not to be or to become pregnant while taking Tracleer or one month after stopping treatment and to have a pregnancy test before you start the drug and each month thereafter. It is very important for you to use reliable forms of birth control while taking Tracleer. Hormonal contraceptives should not be used alone because they may not be effective in patients taking Tracleer. Do not take Tracleer with glyburide because it may increase your chance of liver injury. Do not take Tracleer with cyclosporine-A because it may increase your chance of side effects. Please see Additional Safety Information. Please see full Prescribing Information, including BOXED WARNING and Medication Guide. |
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