| dailymed-drugs:1485 | dailymed-instance:boxedWarn... | WARNING: RISK FOR HEPATOTOXICITY: PROMACTA may cause hepatotoxicity: ���Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation. ���Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels. ���Discontinue PROMACTA if ALT levels increase to���3X the upper limit of normal (ULN) and are: Because of the risk for hepatotoxicity and other risks [see Warnings and Precautions (5.1-5.6)], PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA [see Warnings and Precautions (5.8)]. | lld:dailymed |
