INDICATIONS:Treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH: Avoid coadministration with other products known to cause hepatotoxicity. Avoid concomitant use of CYP3A inhibitors, CYP3A inducers and UGT inhibitors or reduce dose. Avoid concomitant use of proton pump inhibitors.
PREGNANCY: May cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment. Advise male patients with female partners of reproductive potential to use effective contraception during treatment.
CAN CAUSE SERIOUS AND POTENTIALLY FATAL LIVER INJURY. MONITOR LIVER TESTS PRIOR TO AND DURING TREATMENT. WITHHOLD AND DOSE REDUCE OR PERMANENTLY DISCONTINUE TREATMENT BASED ON SEVERITY OF HEPATOTOXICITY.
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