TM Owner Pfizer
Sunitinib 25mg Capsule
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Indications & Clinical Uses
- Sunitinib (Sutent, sunitinib malate) 25 mg capsules are a multi-targeted tyrosine kinase inhibitor used in adults for gastrointestinal stromal tumour (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 tumours that are unresectable or metastatic. 'Sunitinib' on this catalogue entry is the active ingredient name rather than a distinct marketed brand; the approved originator brand is Sutent, marketed by Pfizer, and various generic sunitinib malate capsules are approved in other countries.
- Sunitinib capsules are taken by mouth, once daily, with or without food, usually on a 4-weeks-on/2-weeks-off cycle for GIST and RCC or continuously for pancreatic neuroendocrine tumours, and treatment is directed and monitored by a cancer specialist.
Side Effects
- Sunitinib (Sutent) carries a boxed warning: hepatotoxicity may be severe and has been fatal in some patients, so liver function is checked before starting and periodically during treatment, and the dose is interrupted or stopped if significant liver injury occurs.
- Very common side effects, affecting 25% or more of patients, include fatigue, diarrhoea, mouth sores, nausea, decreased appetite, vomiting, abdominal pain, hand-foot skin reactions, high blood pressure, bleeding, altered taste, indigestion and low platelet counts.
- Other serious reactions include heart failure, QT interval prolongation and abnormal heart rhythms, severe high blood pressure, thyroid problems, and a rare brain-swelling condition called reversible posterior leukoencephalopathy syndrome.
- Seek urgent medical attention for yellowing of the skin or eyes, dark urine, unusual bleeding or bruising, worsening chest pain, sudden severe headache with vision changes, or swelling with breathlessness, and report skin blistering or peeling promptly.
Precautions & Warnings
- Because of the boxed hepatotoxicity warning, liver function tests are performed regularly throughout treatment with Sunitinib (Sutent), and treatment is withheld or discontinued for grade 3 or 4 liver test abnormalities or signs of liver failure.
- Blood pressure, heart function and thyroid function are monitored, and QT-prolonging effects mean caution is needed with a personal or family history of QT prolongation or with other QT-prolonging medicines.
- Sunitinib can cause fetal harm, so effective contraception is required during treatment and for a period after the last dose for both women and men, and it should not be used in pregnancy.
- Adrenal function should be assessed under stress such as surgery or serious illness.
- Wound healing may be impaired, so treatment is usually interrupted around major surgery.
- Renal function and urine protein are checked periodically, and dose reductions are used in significant hepatic or renal impairment.
Avoid Interactions
- Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and grapefruit or grapefruit juice, raise sunitinib blood levels and toxicity, so a dose reduction is usually needed, and grapefruit products should generally be avoided.
- Strong CYP3A4 inducers, including rifampin, phenytoin, carbamazepine and St John's Wort, lower sunitinib levels and can reduce its effectiveness, so an alternative or dose increase may be required; St John's Wort should be avoided altogether.
- Other medicines that prolong the QT interval, such as certain antiarrhythmics, antipsychotics and some antibiotics, should be used cautiously with sunitinib because of added abnormal-heart-rhythm risk.
- Tell your cancer specialist about every prescription medicine, over-the-counter product, herbal remedy and supplement you take, since many can affect sunitinib levels or add to its side effects, including bleeding risk when combined with anticoagulants or antiplatelet drugs.
References
Frequently Asked Questions
Sunitinib, sold under the brand Sutent, is a targeted cancer capsule used for gastrointestinal stromal tumours after imatinib fails, advanced kidney cancer, kidney cancer after surgery in high-risk patients, and certain pancreatic neuroendocrine tumours. It blocks signals cancer cells use to grow and form blood vessels.
Sunitinib capsules are swallowed whole, once daily, with or without food, at about the same time each day. Depending on your cancer type, you take it for 4 weeks then have a 2-week break, or continuously, following your cancer specialist's exact schedule.
Sunitinib carries a boxed warning for serious, sometimes fatal liver damage, so blood tests check your liver regularly. Very common effects include fatigue, diarrhoea, mouth sores, nausea, high blood pressure and hand-foot skin reactions. Get urgent care for yellowing skin, dark urine or unusual bleeding.
Avoid grapefruit and grapefruit juice, which raise sunitinib levels, and St John's Wort, which lowers them. Tell your specialist about all other medicines, since strong CYP3A4 inhibitors or inducers, and QT-prolonging drugs, change how sunitinib works or add to heart risks.
While taking Sunitinib, you need regular blood tests for liver function, blood counts and thyroid function, plus blood pressure checks and sometimes heart scans. This monitoring catches the boxed-warning liver risk and other serious effects early, so keep every scheduled appointment.
No. Sunitinib can harm an unborn baby, so effective contraception is needed during treatment and for a period afterwards for both women and men. Tell your cancer specialist immediately if you are or could be pregnant, or are planning pregnancy, before starting treatment.
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