Risk of ILD/pneumonitis; HTN; hepatotoxicity; hemorrhagic events; impaired wound healing. Do not initiate treatment in patients w/ uncontrolled HTN. Monitor BP 1 wk after treatment initiation, at least mthly thereafter & as clinically indicated. Monitor AST & ALT prior to initiating treatment, every 2 wk during the 1st 3 mth, then mthly thereafter & as clinically indicated. Patients may be at risk of tumor lysis syndrome if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Withhold, reduce dose or permanently discontinue Gavreto based on severity of confirmed ILD, HTN, or hepatotoxicity. Permanently discontinue in patients w/ severe or life-threatening hemorrhage. Withhold treatment for at least 5 days prior to elective surgery. Do not administer for at least 2 wk following major surgery & until adequate wound healing. Avoid co-administration w/ known combined P-gp & strong CYP3A inhibitors, or w/ strong CYP3A inducers. Has not been studied in patients w/ moderate or severe hepatic impairment. Can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraception during treatment & for 2 wk after the final dose. Advise males w/ female partners of reproductive potential to use effective contraception during treatment & for 1 wk after the final dose. Advise women not to breastfeed during treatment & for 1 wk after the final dose. Safety & effectiveness have not been established in ped patients w/
RET fusion +ve NSCLC.
Sign Out
