Important Safety Information
Women of childbearing potential should be advised of the potential hazard to the
fetus and to avoid becoming pregnant.
Given the potential for serious adverse reactions in nursing infants, a decision
should be made whether to discontinue nursing or SUTENT.
Left ventricular ejection fraction declines to below the lower limit of normal have
occurred. Monitor patients for signs and symptoms of congestive heart failure (CHF)
and, in the presence of clinical manifestations, discontinuation is recommended.
Patients who presented with cardiac events, pulmonary embolism, or cerebrovascular
events within the previous 12 months were excluded from clinical studies.
SUTENT has been shown to prolong QT interval in a dose-dependent manner, which may
lead to an increased risk for ventricular arrhythmias including torsade de pointes,
which has been seen in <0.1% of patients. Monitoring with on-treatment electrocardiograms
and electrolytes should be considered.
Hypertension may occur. Monitor blood pressure and treat as needed.
There have been rare (<1%) reports of subjects with seizures and radiological
evidence of reversible posterior leukoencephalopathy syndrome (RPLS). None resulted
in a fatal outcome.
Hemorrhagic events including tumor-related hemorrhage have occurred. Perform serial
complete blood counts (CBCs) and physical examinations.
In an ongoing clinical trial of patients with metastatic non-small cell lung cancer
(NSCLC), fatal pulmonary hemorrhage occurred in 2 patients, both with squamous cell
histology. SUTENT is not approved for use in patients with NSCLC.
Thyroid dysfunction may occur. Monitor thyroid function in patients with signs and/or
symptoms of hypothyroidism or hyperthyroidism and treat per standard medical practice.
Adrenal hemorrhage was observed in animal studies. Monitor adrenal function in case
of stress such as surgery, trauma, or severe infection.
CBCs and serum chemistries should be performed at the beginning of each treatment
cycle.
Dose adjustments are recommended when administered with CYP3A4 inhibitors or inducers.
The most common adverse reactions (ARs) occurring in ≥20% of patients receiving
SUTENT for treatment-naïve metastatic RCC (all grades, vs IFNα) were fatigue (58%
vs 55%), diarrhea (58% vs 20%), nausea (49% vs 38%), altered taste (44% vs 14%),
mucositis/stomatitis (43% vs 4%), anorexia (38% vs 40%), bleeding, all sites (30%
vs 8%), hypertension (30% vs 4%), vomiting (28% vs 14%), dyspepsia (28% vs 4%),
rash (27% vs 11%), abdominal pain (22% vs 12%), asthenia (21% vs 24%), and hand-foot
syndrome (21% vs 1%). The most common grade 3/4 ARs (occurring in ≥5% of SUTENT
patients) were hypertension (10% vs <1%), fatigue (9% vs 14%), asthenia (7% vs
6%), diarrhea (6% vs 0%), and hand-foot syndrome (5% vs 0%).
The most common grade 3/4 lab abnormalities occurring in ≥8% of patients with treatment-naïve
metastatic RCC receiving SUTENT (vs IFNα) included lipase (16% vs 6%), uric acid
(12% vs 8%), neutrophils (12% vs 7%), lymphocytes (12% vs 22%), and platelets (8%
vs 0%).
The most common ARs occurring in ≥20% of patients with GIST and more commonly with
SUTENT than placebo (all grades, vs placebo) were diarrhea (40% vs 27%), anorexia
(33% vs 29%), skin discoloration (30% vs 23%), mucositis/stomatitis (29% vs 18%),
asthenia (22% vs 11%), altered taste (21% vs 12%), and constipation (20% vs 14%).
The most common grade 3/4 ARs (occurring in ≥4% of SUTENT patients) were asthenia
(5% vs 3%), hand-foot syndrome (4% vs 3%), diarrhea (4% vs 0%), and hypertension
(4% vs 0%).
The most common grade 3/4 lab abnormalities occurring in ≥5% of patients with GIST
receiving SUTENT (vs placebo) included lipase (10% vs 7%), neutrophils (10% vs 0%),
amylase (5% vs 3%), and platelets (5% vs 0%).