(37) 1 (1)
Phosphorus decreased 81 29 (36) 6 (7) 77 17 (22) 4 (5)
Calcium decreased 82 28 (34) 0 (0) 80 15 (19) 0 (0)
Sodium decreased 82 24 (29) 2 (2) 80 27 (34) 2 (3)
Creatinine increased 82 22 (27) 4 (5) 80 22 (28) 4 (5)
Glucose decreased 82 18 (22) 2 (2) 80 12 (15) 3 (4)
Potassium decreased 82 17 (21) 3 (4) 80 11 (14) 0 (0)
Magnesium decreased 52 10 (19) 0 (0) 39 4 (10) 0 (0)
Potassium increased 82 15 (18) 1 (1) 80 9 (11) 1 (1)
Hematology
Neutrophils decreased 82 58 (71) 13 (16) 80 13 (16) 0 (0)
Hemoglobin decreased 82 53 (65) 0 (0) 80 44 (55) 1 (1)
Platelets decreased 82 49 (60) 4 (5) 80 12 (15) 0 (0)
Lymphocytes decreased 82 46 (56) 6 (7) 80 28 (35) 3 (4)
6.4Venous Thromboembolic Events
Seven patients (3%) on SUTENT and none on placebo in the double-blind treatment phase of GIST Study A experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT), and two were Grade 1 or 2. Four of these seven GIST patients discontinued treatment following first observation of DVT.
Thirteen (3%) patients receiving SUTENT for treatment-naïve RCC had venous thromboembolic events reported. Seven (2%) of these patients had pulmonary embolism, one was Grade 2 and six were Grade 4, and six (2%) patients had DVT, including three Grade 3. One patient was permanently withdrawn from SUTENT due to pulmonary embolism; dose interruption occurred in two patients with pulmonary embolism and one with DVT. In treatment-naïve RCC patients receiving IFN-α, six (2%) venous thromboembolic events occurred; one patient (<1%) experienced a Grade 3 DVT and five patients (1%) had pulmonary embolism, all Grade 4. One patient (1%) receiving SUTENT for pNET had a venous thromboembolic event reported compared to 5 patients (6%) receiving placebo. The SUTENT patient had Grade 2 thrombosis. Two placebo patients had DVT, one was Grade 3, two placebo patients had pulmonary embolism, one was Grade 3 and one was Grade 4, and one placebo patient had Grade 3 jugular thrombosis.
6.5Reversible Posterior Leukoencephalopathy Syndrome
There have been rare (<1%) reports of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS). None of these subjects had a fatal outcome to the event. Patients with seizures and signs/symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness should be controlled with medical management including control of hypertension. Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.
6.6Pancreatic and Hepatic Function
If symptoms of pancreatitis or hepatic failure are present, patients should have SUTENT discontinued. Pancreatitis was observed in 5 (1%) patients receiving SUTENT for treatment-naïve RCC compared to 1 (<1%) patient receiving IFN-α. Pancreatitis was observed in 1 (1%) patient receiving SUTENT for pNET and 1 (1%) patient receiving placebo. Hepatotoxicity was observed in patients receiving SUTENT [See Boxed Warning and Warnings and Precautions (5.1)].
6.7Post-marketing Experience
The following adverse reactions have been identified during post-approval use of SUTENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possib |
