Inlyta Disease Interactions

Fatal hemorrhagic events, including cerebral hemorrhage, hematuria, hemoptysis, lower gastrointestinal hemorrhage, and melena have been reported with the use of axitinib. Therapy with axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in these patients. If any bleeding requires medical intervention, it is recommended to temporarily interrupt the axitinib dose and to stop treatment at least 24 hours prior to scheduled surgery. The decision to resume therapy after surgery should be based on clinical judgment of adequate wound healing.

Cardiac failure, including fatal events have been reported in patients receiving axitinib. It is recommended to monitor for signs or symptoms of cardiac failure throughout treatment. Management of cardiac failure may require permanent discontinuation of therapy. Care should be taken when using this agent in patients at risk.

Therapy with axitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation, such as those with a history of diverticulitis. Patients presenting with new onset of abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation. It is recommended to monitor for symptoms of gastrointestinal perforation or fistula periodically throughout the treatment.

The systemic exposure to axitinib is higher in subjects with moderate hepatic impairment. Dose adjustment is recommended in patients with moderate hepatic impairment. No dose adjustment is required in patients with mild hepatic impairment. The use of axitinib has not been studied in subjects with severe hepatic impairment. It is recommended to monitor liver enzymes and bilirubin before the start of therapy and periodically thereafter.

The use of axitinib may causes hypertension. Blood pressure should be well-controlled prior to initiating axitinib and treated as needed with standard anti-hypertensive therapy. It is recommended to reduce the dose in case of persistent hypertension despite use of anti-hypertensive medications and to discontinue therapy if hypertension is severe and persistent despite these measures. Discontinuation of therapy should be considered if there is evidence of hypertensive crisis. Close monitoring is recommended.

Proteinuria has been reported in patients taking axitinib. It is recommended to monitor for proteinuria before initiation of therapy, and periodically thereafter. Reduce dose or temporarily interrupt therapy in patients who develop moderate to severe proteinuria.

Based on population pharmacokinetic analyses no starting dose adjustment is needed for patients with mild to severe renal impairment. It is recommended to take caution in patients with end-stage renal disease.

Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in patients receiving axitinib. Consider this syndrome in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. It is recommended to discontinue therapy in patients developing RPLS. The safety of reinitiating therapy in patients previously experiencing RPLS is not known. Care and close monitoring should be considered in these patients.

Arterial and venous thromboembolic events, including transient ischemic attack, cerebrovascular accident, myocardial infarction, pulmonary embolism, deep vein thrombosis, retinal occlusion, vein thrombosis, and deaths have been reported with the use of axitinib. Use with caution in patients who are at risk for, or who have a history of, these events. The use of axitinib has not been studied in patients who had an arterial or venous thromboembolic event within the previous 12 months. It is recommended to monitor closely for signs and symptoms of thromboembolism.

Thyroid level fluctuations that include hypothyroidism and hyperthyroidism have been reported with the use of axitinib. It is recommended to monitor thyroid function before initiation of, and periodically throughout treatment and to maintain euthyroid state according to standard medical practice.

The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.