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Sutent 50mg Capsule
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Indications & Clinical Uses
- Sutent 50 mg capsules contain sunitinib malate, an oral multi-targeted tyrosine kinase inhibitor that blocks VEGF and PDGF receptors and other kinases involved in tumor blood-vessel growth.
- It is approved in adults for gastrointestinal stromal tumor (GIST) after disease progression on, or intolerance to, imatinib; for advanced renal cell carcinoma (RCC); as adjuvant treatment after nephrectomy in adults at high risk of recurrent RCC; and for progressive, well-differentiated pancreatic neuroendocrine tumors that are unresectable, locally advanced or metastatic.
- For GIST and RCC the usual schedule is 50 mg once daily for four weeks followed by two weeks off treatment (Schedule 4/2); for pancreatic neuroendocrine tumors it is usually taken continuously every day at a lower dose.
- Sutent is self-administered orally at home, with or without food, and safety and effectiveness in children have not been established.
Side Effects
- Very common effects, each reported in 25 percent or more of patients, include fatigue, diarrhea, mouth soreness (mucositis or stomatitis), nausea, reduced appetite, vomiting, abdominal pain, hand-foot skin reaction, high blood pressure, bleeding, an altered sense of taste, indigestion and low platelet counts.
- Sutent carries a boxed warning for hepatotoxicity: liver injury can be severe and has been fatal in some patients, so liver function is checked before starting and during each cycle.
- Seek urgent medical care for yellowing of the skin or eyes, dark urine, severe or persistent abdominal pain, unusual bruising or bleeding, chest pain, sudden breathlessness or leg swelling (possible heart problems), fainting, or a severe skin reaction with blistering or peeling.
- Report high fevers, seizures or severe headache promptly, as these can signal other serious reactions.
Precautions & Warnings
- Because of the boxed hepatotoxicity warning, liver function tests are done before treatment and periodically during each cycle, and Sutent is interrupted, dose-reduced or stopped for signs of liver injury.
- Blood pressure, heart function (including left ventricular ejection fraction in at-risk patients) and the QT interval on ECG should be monitored, since sunitinib can cause hypertension, heart failure and QT prolongation; correct low potassium or magnesium before starting.
- Watch for bleeding, thyroid dysfunction, protein in the urine, unusual fatigue from adrenal insufficiency during periods of physical stress, and severe skin reactions such as Stevens-Johnson syndrome, which require stopping treatment.
- Sutent should be paused before planned surgery to allow wound healing, and effective contraception is required during treatment and for a period afterwards because of possible harm to a developing baby; avoid breastfeeding while taking it.
Avoid Interactions
- Avoid grapefruit and grapefruit juice, along with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin and ritonavir, because they raise sunitinib blood levels; if a strong inhibitor cannot be avoided, your doctor may lower the Sutent dose.
- Strong CYP3A4 inducers, including rifampin, phenytoin, carbamazepine and St John's Wort, reduce sunitinib levels and effectiveness and should be avoided, or the dose may need to be increased under close supervision.
- Because Sutent can prolong the QT interval, tell your doctor about other medicines that affect heart rhythm, such as certain antiarrhythmics or antipsychotics.
- Tell your healthcare provider and pharmacist about every prescription and over-the-counter medicine, herbal product and supplement you take before starting Sutent and at each visit.
References
Frequently Asked Questions
Sutent (sunitinib) treats gastrointestinal stromal tumor after imatinib fails, advanced kidney cancer, kidney cancer at high risk of returning after surgery, and advanced pancreatic neuroendocrine tumors. It works by blocking blood-vessel growth signals that tumors need to grow and spread.
Sutent capsules are swallowed once daily, with or without food, at about the same time each day. For most cancers the schedule is 4 weeks on treatment then 2 weeks off; pancreatic neuroendocrine tumors are usually treated continuously every day.
Fatigue, diarrhea, mouth soreness, nausea, hand-foot skin reaction and high blood pressure are very common. Sutent carries a boxed warning for hepatotoxicity, liver injury that can be severe or fatal. Get urgent care for yellowing skin, dark urine or severe abdominal pain.
Avoid grapefruit and grapefruit juice, and strong CYP3A4 inhibitors like ketoconazole or clarithromycin, which raise Sutent levels. Avoid strong inducers such as rifampin or St John's Wort, which lower its effect. Tell your doctor about every medicine and supplement you use.
If you miss a Sutent dose, take it as soon as you remember that day, but never double up or take two doses close together to make up for it. Skip the missed dose if it is almost time for the next one, and continue your usual schedule.
No. Sutent (sunitinib) can harm a developing baby, so effective contraception is required during treatment and for a period after the last dose, for both women and male partners. Avoid breastfeeding while taking Sutent, and discuss family planning with your oncologist first.
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