Sunitinib
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Fulminant liver failure (first report) in an elderly patient: case report A 75-year-old woman with metastatic renal cell carcinoma developed fulminant liver failure after receiving a cycle of sunitinib therapy. Two months after a right nephrectomy for newly diagnosed clear-cell variant, grade 3 renal cell carcinoma, the woman began treatment with sunitinib [dosage not stated], with each cycle comprising 4 weeks of sunitinib followed by 2 weeks without sunitinib. During treatment she experienced grade 1 fatigue, arthralgia and xerostomia (all 5 cycles), grade 2 thrombocytopenia and grade 4 neutropenia (cycle 2), right lower quadrant pain (cycle 2 and between cycles 3 and 4), diarrhoea (end of cycle 4) and CT-confirmed hepatic cysts (between cycles 4 and 5). Before initiating sunitinib and during 5 cycles of therapy, her AST, ALT, ALP, total bilirubin and blood urea nitrogen (BUN) levels were within normal limits and her serum creatinine levels were 1.3–1.4 mg/mL (normal 0.5–1.2). Four days after completing the active drug phase of cycle 5 (9 months after starting sunitinib), she presented with a 3-day history of severe diarrhoea and dehydration, as well as increasing lethargy and changes in her mental status. Laboratory testing on admission revealed decreased WBC and platelet counts (3.0 and 56 × 103/mm3, respectively), elevated levels of AST, ALT and creatine kinase (3872, 3332 and 21 729 U/L, respectively) and elevated levels of BUN, serum creatinine, total bilirubin and ammonia (84, 2.7 and 5.9 mg/dL and 897 µg/dL [27–90], respectively). Testing also revealed an INR of 4.8, her coagulation factors V and VII were < 25% and her factor VIII level was increased to 286% of normal. These results were indicative of abnormal hepatic function. Viral serology testing was negative. An ultrasound scan of her right upper quadrant showed increased echogenicity of her liver and a hyperechoic lesion was seen within her gallbladder, suggestive of gallstones. Doppler evaluation showed reversed flow in the hepatic veins, indicating venous reflux with normal vessel patency. These findings were not considered consistent with metastatic disease. Fulminant liver failure and associated acute renal failure secondary to sunitinib was diagnosed and the woman was rehydrated with IV saline and received fresh frozen plasma, lactulose and rifaximin. Her mental status returned to baseline over 5 days, her hyperammonaemia resolved and her AST and ALT levels improved, as did her coagulopathy. She was discharged on day 7. Repeat testing at 1 and 6 months postdischarge showed that her liver function had returned to normal. Author comment: "[T]he patient had a score of 12 on the drug-related hepatotoxicity clinical diagnostic scale, suggesting probable sunitinib-related hepatotoxicity. Further, a possible relationship was indicated by the patient’s score of 3 on the Naranjo adverse drug reaction probability scale". Mueller EW, et al. Sunitinib-related fulminant hepatic failure: case report and review of the literature. Pharmacotherapy 28: 106
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