tients (1%) receiving sorafenib. Fatal pulmonary embolism was reported in 1/359 patients (<1%) receiving Inlyta and none of the patients receiving sorafenib. In clinical trials with Inlyta, venous thromboembolic events were reported in 22/715 patients (3%), with two deaths secondary to pulmonary embolism.
Use Inlyta with caution in patients who are at risk for, or who have a history of, these events. Inlyta has not been studied in patients who had a venous thromboembolic event within the previous 6 months.
Hemorrhage
In a controlled clinical study with Inlyta for the treatment of patients with RCC, hemorrhagic events were reported in 58/359 patients (16%) receiving Inlyta and 64/355 patients (18%) receiving sorafenib. Grade 3/4 hemorrhagic events were reported in 5/359 (1%) patients receiving Inlyta (including cerebral hemorrhage, hematuria, hemoptysis, lower gastrointestinal hemorrhage, and melena) and 11/355 (3%) patients receiving sorafenib. Fatal hemorrhage was reported in 1/359 patients (<1%) receiving Inlyta (gastric hemorrhage) and 3/355 patients (1%) receiving sorafenib.
Inlyta has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the Inlyta dose.
Gastrointestinal Perforation and Fistula Formation
In a controlled clinical study with Inlyta for the treatment of patients with RCC, gastrointestinal perforation was reported in 1/359 patients (<1%) receiving Inlyta and none of the patients receiving sorafenib. In clinical trials with Inlyta, gastrointestinal perforation was reported in 5/715 patients (1%), including one death. In addition to cases of gastrointestinal perforation, fistulas were reported in 4/715 patients (1%).
Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment with Inlyta.
Thyroid Dysfunction
In a controlled clinical study with Inlyta for the treatment of patients with RCC, hypothyroidism was reported in 69/359 patients (19%) receiving Inlyta and 29/355 patients (8%) receiving sorafenib. Hyperthyroidism was reported in 4/359 patients (1%) receiving Inlyta and 4/355 patients (1%) receiving sorafenib. In patients who had thyroid stimulating hormone (TSH) <5 μU/mL before treatment, elevations of TSH to ≥10 μU/mL occurred in 79/245 patients (32%) receiving Inlyta and 25/232 patients (11%) receiving sorafenib [see Adverse Reactions (6.1)].
Monitor thyroid function before initiation of, and periodically throughout, treatment with Inlyta. Treat hypothyroidism and hyperthyroidism according to standard medical practice to maintain euthyroid state.
Wound Healing Complications
No formal studies of the effect of Inlyta on wound healing have been conducted.
Stop treatment with Inlyta at least 24 hours prior to scheduled surgery. The decision to resume Inlyta therapy after surgery should be based on clinical judgment of adequate wound healing.
Reversible Posterior Leukoencephalopathy Syndrome
In a controlled clinical study with Inlyta for the treatment of patients with RCC, reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 1/359 patients (<1%) receiving Inlyta and none of the patients receiving sorafenib [see Adverse Reactions (6.1)]. There were two additional reports of RPLS in other clinical tri |
