Adult Dosing
Gastrointestinal stromal tumor
- 50 mg PO qd x 4 wks on treatment followed by 2 wks of rest
- Repeat cycle of 4 wks on and 2 wks off therapy; adjust dose in 12.5 mg increments or decrements based on individual safety and tolerability
- If co-administered with a strong CYP3A4 inhibitor (ketoconazole): Consider decreasing the dose to a minimum of 37.5 mg/day
- If used with a strong CYP3A4 inducer (rifampin): Consider increasing the dose to a maximum of 87.5 mg/day
Note:
- Carefully monitor for toxicity if the dose is increased
Advanced renal cell carcinoma
- 50 mg PO qd x 4 wks followed by 2 wks of rest
- Repeat cycle of 4 wks on and 2 wks off therapy; adjust dose in 12.5 mg increments or decrements based on individual safety and tolerability
- If co-administered with a strong CYP3A4 inhibitor (ketoconazole): Consider decreasing the dose to a minimum of 37.5 mg/day
- If used with a strong CYP3A4 inducer (rifampin): Consider increasing the dose to a maximum of 87.5 mg/day
Note:
- Carefully monitor for toxicity if the dose is increased
Pancreatic neuroendocrine tumors
- 37.5 mg PO qd, taken continuously without a scheduled off-treatment period
- Adjust dose in 12.5 mg increments or decrements based on individual safety and tolerability
- If co-administered with a strong CYP3A4 inhibitor (ketoconazole): Consider decreasing the dose to a minimum of 25 mg/day
- If used with a strong CYP3A4 inducer (rifampin): Consider increasing the dose to a maximum of 62.5 mg/day
Note:
- Carefully monitor for toxicity if the dose is increased
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Hepatotoxicity has been reported in clinical trials and post-marketing experience, which could be severe and fatal [US Black Box Warning]
- Observe for signs of hepatic failure, which include jaundice, elevated transaminases and/or hyperbilirubinemia in conjunction with encephalopathy, coagulopathy, and/or renal failure. Monitor LFTs (AST, ALT, and bilirubin) prior to treatment initiation, during each treatment cycle, and as clinically needed
- Discontinue treatment if grade 3 or 4 drug-related hepatic adverse events occur and if there is no resolution; do not restart if patients experience severe changes in LFTs or develop other signs and symptoms of hepatic failure
- Sunitinib inhibits angiogenesis, which is a critical component of embryonic and fetal development; apprise women of childbearing potential of the potential hazard to the fetus and advise them to avoid becoming pregnant during therapy
- Cardiovascular events such as heart failure, decline in left ventricular ejection fraction (LVEF), myocardial disorders and cardiomyopathy, some of which were fatal, have been reported during sunitinib therapy; discontinue therapy on occurrence of clinical signs and symptoms of CHF. Monitor closely for signs and symptoms of CHF during therapy. Left ventricular dysfunction may cause decrease in LVEF; perform baseline and periodic evaluations of LVEF during therapy
- QT interval prolongation and torsade de pointes have been reported during the therapy. Use with caution in susceptible patients at higher risk for developing QT interval prolongation; monitor regularly with ECG and electrolytes such as magnesium and potassium during treatment. Exercise caution and reduce the sunitinib dose during concomitant therapy with strong CYP3A4 inhibitors
- If severe hypertension occurs during treatment, discontinue the drug until hypertension is controlled; monitor for hypertension and institute standard anti-hypertensive therapy
- Hemorrhagic events such as GI, respiratory, tumor, urinary tract, brain hemorrhages, epistaxis, rectal, gingival, genital, and wound bleeding have been reported. Perform serial CBCs and physical examinations
- Osteonecrosis of the jaw has been reported in clinical trials and post-marketing experience in patients treated with sunitinib; exposure to risk factors (eg, dental disease, bisphosphonates) may increase the risk of ONJ
- Tumor lysis syndrome has been reported in post-marketing experience; closely monitor patients presenting with a high tumor burden prior to treatment and treat as clinically indicated
- Measure baseline thyroid function in patients with hypothyroidism or hyperthyroidism and treat as per standard medical practice prior to initiating sunitinib therapy and closely monitor for signs and symptoms of thyroid dysfunction during the therapy
- Closely observe for adrenal insufficiency in patients who experience stress (e.g., severe infection, surgery, trauma)
- Instances of impaired wound healing have been reported during treatment
- Perform CBCs with platelet count and serum chemistries including phosphate at the beginning of each treatment cycle in patients receiving sunitinib treatment
Cautions: Use Cautiously in
- History of QT interval prolongation
- Patients on antiarrhythmic agent
- Bradycardia
- Ischemic cardiac event within 1 year of treatment
- Thromboembolic event within 1 year
- Hypothyroidism
- Proteinuria
- Thyroid disorder
Pregnancy Category:D
Breastfeeding: Possibly unsafe. As per manufacturer's data, because many drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Sutent 50 MG CAPS [Bottle] (PFIZER U.S.)
28 mg = $10465.92
84 mg = $30651.87 - Sutent 25 MG CAPS [Bottle] (PFIZER U.S.)
28 mg = $5508.22
84 mg = $15833.17 - Sutent 12.5 MG CAPS [Bottle] (PFIZER U.S.)
28 mg = $2596.1
84 mg = $7729.69
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
