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SUTENT is a brand name for Sunitinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Patients receiving therapy with SUTENT (sunitinib malate) should be monitored by a qualified physician experienced in the use of anti-cancer agents. Tumour Hemorrhage (see WARNINGS AND PRECAUTIONS, Hemorrhage) Decreases in left ventricular ejection fraction (LVEF), including fatal cases (see WARNINGS AND PRECAUTIONS, Left Ventricular Dysfunction) Hypertension (see WARNINGS AND PRECAUTIONS, Hypertension) QT Interval Prolongation, including fatality (see WARNINGS AND PRECAUTIONS, QT Interval Prolongation and DRUG INTERACTIONS).
Cardiomyopathy, including fatal cases (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions) Cases of cerebrovascular and cardiovascular events, including fatal cases (see WARNINGS AND PRECAUTIONS, Arterial Thromboembolic Events) Pulmonary embolism, including fatal cases (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions) Thrombotic Microangiopathy, including fatal cases (see WARNINGS AND PRECAUTIONS, Thrombotic Microangiopathy) SUTENT has not been studied in patients with severe hepatic impairment.
Fatal Hepatotoxicity (See WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and Thyroid Dysfunction, and ADVERSE REACTIONS, Post-Market Adverse Drug Reactions) Myopathy and/or rhabdomyolysis, including fatality (see ADVERSE REACTIONS, Post- Market Adverse Drug Reactions) Renal failure, including fatal cases (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions) Reversible Posterior Leukoencephalopathy Syndrome, including fatal cases (see WARNINGS AND PRECAUTIONS, Seizures and ADVERSE REACTIONS, Post- Market Adverse Drug Reactions) Pleural Effusion, including fatal cases (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions) Carcinogenesis and Mutagenesis The carcinogenic potential of sunitinib has been evaluated in rasH2 transgenic mice and in Sprague-Dawley rats.
3 times the AUC in patients administered the SUTENT Product Monograph Page 6 of 68 RDD). 7 times the AUC in patients administered the RDD). 8 times the AUC in patients administered the RDD). The relevance to humans of the neoplastic findings observed in the mouse (rasH2 transgenic) and rat carcinogenicity studies with sunitinib treatment is unclear.
(see TOXICOLOGY, Carcinogenicity). Sunitinib has been tested for genotoxicity in a series of in vitro assays (bacterial mutation [Ames Assay], human lymphocyte chromosome aberration) and an in vivo rat bone marrow micronucleus test and did not cause genetic damage.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cardiovascular Hypertension Blood pressure was monitored on a routine basis in the clinical studies. Hypertension was a very common adverse reaction reported in clinical trials in subjects with solid tumors, including primarily GIST and cytokine-refractory RCC1.
In the treatment-naïve MRCC study, two patients were discontinued due to treatment-related hypertension, including one with malignant hypertension, and one patient in the pancreatic NET study discontinued due to treatment-related Grade 3 hypertension.
In the GIST trial (Study A), hypertension (all grades) was reported as an adverse event in 51/257 (19%) patients on SUTENT and 7/102 (7%) patients on placebo. Severe hypertension (> 200 mmHg systolic or > 110 mmHg diastolic) occurred in 9/237 (4%) patients on SUTENT and no patients on placebo.
SUTENT dosing was neither delayed nor reduced due to hypertension in any of the GIST patients in the GIST pivotal trial. Treatment-related hypertension was reported in approximately 30% of patients receiving SUTENT for treatment-naïve MRCC compared to 2% of patients receiving interferon-alfa (IFN- α).
Severe hypertension (> 200 mmHg systolic or > 110 mmHg diastolic) occurred in 9% of treatment-naïve patients on SUTENT and 1% of patients on IFN-α. In the cytokine-refractory metastatic RCC (MRCC) trials, hypertension (all grades) was reported as an adverse event in 47/169 (28%) patients on SUTENT.
Hypertension (>150 mmHg systolic or >100 mmHg diastolic) occurred at least once during the study for 86/165 (52%) patients on SUTENT; severe hypertension (> 200 mmHg systolic or > 110 mmHg diastolic) occurred in 10/165 (6%) patients on SUTENT.
SUTENT dosing was delayed or reduced due to hypertension in 8/165 (4%) cytokine-refractory MRCC patients. 1 From initial clinical trials including primarily patients with GIST and cytokine-refractory MRCC. SUTENT Product Monograph Page 7 of 68 Of patients receiving SUTENT in the Phase 3 pancreatic NET study, 19/83 patients (23%) on SUTENT and 3/82 (4%) patients on placebo experienced treatment-related hypertension.
Grade 3 treatment-related hypertension was reported in 8/83 (10%) pancreatic NET patients on SUTENT, and 0/82 (0%) patients on placebo. SUTENT dosing was delayed or reduced due to hypertension in 6/83 (7%) of pancreatic NET patients.
Severe hypertension (> 200 mmHg systolic or > 110 mmHg diastolic) occurred in 8/80 (10%) of pancreatic NET patients on SUTENT and 2/76 (3%) patients on placebo. Patients should be monitored for hypertension and treated as appropriate with standard antihypertensive therapy.
Temporary suspension of SUTENT is recommended in patients with severe hypertension. Treatment may be resumed once hypertension is controlled. Patients with hypertension that is not controlled by medications should not be treated with […]