Sunitinib Dosage

This dosage information may not include all the information needed to use Sunitinib safely and effectively. See additional information for Sunitinib.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Renal Cell Carcinoma

50 mg orally once a day with or without food.

Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

Usual Adult Dose for Gastrointestinal Stromal Tumor

50 mg orally once a day with or without food.

Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

Usual Adult Dose for Pancreatic Cancer

Pancreatic neuroendocrine tumors (pNET): 37.5 mg orally once daily continuously without a scheduled off treatment period.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Strong CYP450 3A4 inhibitors may increase sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for sunitinib to a minimum of 37.5 mg daily (GIST and RCC) or 25 mg daily (pNET) should be considered if sunitinib must be coadministered with a strong CYP450 3A4 inhibitor.

CYP450 3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for sunitinib to a maximum of 87.5 mg daily (GIST and RCC) or 62.5 mg daily (pNET) should be considered if sunitinib must be coadministered with a CYP450 3A4 inducer. If the dose is increased, the patient should be monitored carefully for toxicity.

The dose of sunitinib should be interrupted and/or reduced in patients without clinical evidence of congestive heart failure but with an ejection fraction <50% and >20% below baseline.

Precautions

Sunitinib related hepatotoxicity has been reported in clinical trials and postmarketing experience. Liver function tests (e.g., ALT, AST, bilirubin) are recommended prior to initiating therapy, during each cycle, and whenever clinically appropriate. The safety of sunitinib in patients with elevated liver enzymes (ALT or AST greater than 2.5 times the upper limit of normal or greater than 5 times the upper limit of normal in patients with liver metastases) has not been established. Therapy should be interrupted in patients who develop grade 3 or 4 sunitinib related hepatotoxicity and discontinued if symptoms do not resolve. Sunitinib should not be restarted in patients who subsequently exhibit severe changes in liver function tests or have other signs and symptoms of liver failure.

Baseline and periodic evaluations of LVEF should also be considered while the patient is receiving sunitinib. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.

In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended. The dose of sunitinib should be interrupted and/or reduced in patients without clinical evidence of CHF but with an ejection fraction less than 50% and greater than 20% below baseline.

Sunitinib has been shown to prolong the QT interval in a dose dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes. When using sunitinib, periodic monitoring of electrocardiograms and electrolytes (magnesium, potassium) should be considered.

Hypertension was reported in thirty four percent of RCC patients, fifteen percent of GIST patients and twenty seven percent of pNET patients on sunitinib. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. In cases of severe hypertension, temporary suspension of sunitinib is recommended until hypertension is controlled.

Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through postmarketing experience. Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on sunitinib treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.

Physicians prescribing sunitinib are advised to monitor for adrenal insufficiency in patients who experience stress such as surgery, trauma, or severe infection.

Complete blood counts with platelet count and serum chemistries including phosphate should be performed at the beginning of each treatment cycle for patients receiving treatment with sunitinib.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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