आर्सेनिक ट्राइऑक्साइड और ट्रेटिनोइन का इंटरैक्शन

Hepatotoxicity: Elevated aspartate aminotransferase (AST), alkaline phosphatase and serum bilirubin have occurred in patients with newly-diagnosed low-risk APL treated with arsenic trioxide in combination with tretinoin.

When arsenic trioxide is used in combination with tretinoin, prophylaxis with prednisone is recommended during the induction cycle [see Dosage and Administration (2.1)].

In the clinical trials of patients with newly-diagnosed low-risk APL treated with arsenic trioxide in combination with tretinoin, 11% experienced QTc (Framingham formula) prolongation > 450 msec for men and > 460 msec for women throughout the treatment cycles.

Hepatotoxicity In the clinical trials, 44% of patients with newly-diagnosed low-risk APL treated with arsenic trioxide in combination with tretinoin experienced elevated aspartate aminotransferase (AST), alkaline phosphatase and/or serum bilirubin.

Withhold arsenic trioxide and/or tretinoin if elevations in AST or alkaline phosphatase occur to greater than 5 times the upper limit of normal and/or elevation in serum total bilirubin occurs to greater than 3 times the upper limit of normal and resume at reduced dose upon resolution [see Dosage and Administration ( 2.3 )].