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Stivarga was developed and reviewed under the fast track program and received priority review designation from the FDA. These designations are granted by the FDA to expedite the development and review of drugs to treat serious diseases and fill an unmet medical need (fast track), and given to drugs that provide a treatment where no adequate therapy exists (priority review).
For full prescribing information, including BOXED WARNINGS, visit www.Stivarga-us.com. Bayer offers patient assistance through the Bayer REACH® (Resources for Expert Assistance and Care Helpline) program. Patients may contact the REACH Program at 1-866-639-2827 for additional information.
Important Safety Information for Stivarga (regorafenib)
WARNING: HEPATOTOXICITY: Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values.
In clinical trials, Stivarga was associated with an increased incidence of hemorrhage, including fatal hemorrhage. Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.
Hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and rash are the most frequently observed dermatological reactions with Stivarga. Temporarily hold and then reduce or permanently discontinue Stivarga depending on the severity and persistence of dermatologic toxicity.
An increased incidence of hypertension has been observed with Stivarga. Do not initiate Stivarga until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension.
Stivarga has been associated with an increased incidence of myocardial ischemia and infarction. Withhold Stivarga in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events.
Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported with Stivarga. Confirm the diagnosis of RPLS with MRI and discontinue Stivarga in patients who develop RPLS.
Gastrointestinal perforation and fistula have been reported in patients treated with Stivarga. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.
Treatment with Stivarga should be stopped at least 2 weeks prior to scheduled surgery. The decision to resume regorafenib after surgery should be based on clinical judgment of adequate wound healing. Stivarga should be discontinued in patients with wound dehiscence.
Stivarga can cause fetal harm when administered to a pregnant woman. If this drug is used duri |
