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Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be doneSuch signs and symptoms may include unusual fatigueanorexianausea and/or vomitingabdominal painjaundicedark urine or pale stoolssee WARNINGS section

Hepatobiliary Disordersserious hepatotoxicity including hepatitis cholestaticbiopsy-confirmed hepatic necrosiscirrhosishepatic failure including cases resulting in transplantation or death.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Co-administration of ketoconazole with the following agents was shown or is expected to result in increased exposure to these drugsThereforecareful monitoring of plasma concentrations or adverse events of these drugs is recommendedAdjustment of dosage of these drugs may be needed.

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