Sunitinib Malate
Pronunciation: (soo-NIH-tih-nib).
- Generic name
- sunitinib malate
- Brand names
- Suninat, Sutent, Sutinat
- Drug class
- Tyrosine kinase inhibitor (antineoplastic agent)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What sunitinib malate is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how sunitinib malate works
Sunitinib is a multi-targeted receptor tyrosine kinase inhibitor. It blocks several cellular receptors, including vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs), KIT, FLT3, and RET. By inhibiting these kinases, sunitinib disrupts tumor cell proliferation and angiogenesis, leading to reduced tumor growth and metastasis. (1)
What sunitinib malate is used for
Treatment of gastrointestinal stromal tumor (GIST) after disease progression on, or intolerance to, imatinib; advanced renal cell carcinoma (RCC), including as adjuvant treatment after nephrectomy in patients at high risk of recurrence; and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) that are unresectable, locally advanced, or metastatic.
Sunitinib is a tyrosine kinase inhibitor prescribed by an oncology specialist, with dosing that differs by indication. (1)
Before taking sunitinib malate
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to sunitinib or any excipients. (Contraindication) (1)
- Not recommended during pregnancy or breastfeeding. (Contraindication) (1)
Tell your clinician about
(1)How to take sunitinib malate
- General Instructions: Take sunitinib exactly as prescribed, usually once daily with or without food. Do not change your dose or schedule without consulting your doctor.. Adult Dosing: Typical starting dose for most cancers is 50 mg by mouth once daily for 4 weeks, followed by 2 weeks off (6-week cycle). Dose may be adjusted based on response and side effects.. Pediatric Dosing: Safety and effectiveness in children have not been established. Use in pediatric patients is not routinely recommended.. Administration: Swallow capsules or tablets whole with water. Do not crush, chew, or open the capsules.. When To Stop: Do not stop taking sunitinib unless instructed by your doctor. Stopping suddenly may affect treatment outcomes.. Storage: Store at room temperature (20–25°C/68–77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.
Overdose
In case of overdose, seek emergency medical attention or call your local poison control center immediately. Symptoms may include severe fatigue, confusion, or heart rhythm changes. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Fatigue
Incidence: Very common — one of the most frequently reported effects across GIST, renal cell carcinoma, and pancreatic neuroendocrine tumor studies (reported by roughly a third to two-thirds of patients depending on tumor type)
Diarrhea
Incidence: Very common (reported in up to 66% of patients in advanced renal cell carcinoma trials)
Hand-foot syndrome (redness, pain, or peeling of the palms and soles)
Incidence: Common (roughly 14-50% depending on tumor type)
Unusual bruising or bleeding, blood in stool or urine, or coughing up blood
Incidence: Uncommon but serious — sunitinib carries a labeled bleeding risk
Chest pain, swelling of the legs, or an irregular or rapid heartbeat
Incidence: Uncommon but serious — sunitinib is associated with heart failure and rhythm abnormalities requiring monitoring
Serious warnings
May cause serious heart problems, including heart failure and abnormal heart rhythms — serious
Symptoms: May cause serious heart problems, including heart failure and abnormal heart rhythms. Can increase blood pressure; regular monitoring is required. Risk of severe bleeding and gastrointestinal perforation. May cause liver damage; liver function tests are necessary. Can affect thyroid function; thyroid tests may be needed.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with hypersensitivity to sunitinib or any excipients. Use with caution in patients with pre-existing cardiac disease, uncontrolled hypertension, liver impairment, or risk factors for bleeding and gastrointestinal perforation. Not recommended during pregnancy or breastfeeding.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Sunitinib can interact with drugs that affect liver enzymes (CYP3A4), such as ketoconazole, rifampin, and certain anti-seizure medications. These interactions may increase or decrease sunitinib levels in your body, affecting its effectiveness and risk of side effects. Always inform your healthcare provider about all medications, supplements, and herbal products you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Sunitinib can cause fetal harm based on its mechanism of action and animal reproduction data; the FDA label advises against use during pregnancy. Effective contraception should be discussed with the oncology team before, during, and for a period after treatment. (1)
Breastfeeding
Breastfeeding is not recommended during treatment with sunitinib and for a period after the last dose, because of the potential for serious adverse reactions in a breastfed infant. (1)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (1)
Renal_impairment
Renal: no starting-dose adjustment required for mild, moderate, or severe renal impairment; subsequent modifications are based on safety/tolerability. Hepatic: no dose adjustment required for mild or moderate (Child-Pugh Class A or B) hepatic impairment; sunitinib has not been studied in patients with severe (Child-Pugh Class C) hepatic impairment, so use in that population should be individualised with caution. (1)
Hepatic_impairment
Renal: no starting-dose adjustment required for mild, moderate, or severe renal impairment; subsequent modifications are based on safety/tolerability. Hepatic: no dose adjustment required for mild or moderate (Child-Pugh Class A or B) hepatic impairment; sunitinib has not been studied in patients with severe (Child-Pugh Class C) hepatic impairment, so use in that population should be individualised with caution. (1)
Monitoring
(1)Storage
Store sunitinib capsules at 20-25°C (68-77°F); excursions permitted to 15-30°C, per the FDA label. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Recorded indication
Dose summary: 50 mg orally once daily.
Renal context: No adjustment to the starting dose is required when administering sunitinib to patients with mild, moderate, or severe renal impairment. Subsequent dose modifications should be based on individual safety and tolerability. (1)
Frequently asked questions
What types of cancer does sunitinib treat?
Sunitinib is used to treat advanced renal cell carcinoma (kidney cancer), gastrointestinal stromal tumors (GIST) that cannot be removed or have spread, and pancreatic neuroendocrine tumors (pNET).
How long will I need to take sunitinib?
The duration of treatment depends on your cancer type, response to therapy, and side effects. Your doctor will determine the best schedule for you, often in cycles of 4 weeks on and 2 weeks off.
Can I take sunitinib with food?
Yes, sunitinib can be taken with or without food. Take it at the same time each day for best results.
What should I do if I develop severe side effects?
Contact your healthcare provider immediately if you experience severe or unusual symptoms, such as chest pain, severe headache, yellowing of the skin or eyes, or signs of infection.
Are there any foods or drinks I should avoid?
Avoid grapefruit and grapefruit juice, as they can increase the risk of side effects by raising sunitinib levels in your blood.
Is sunitinib safe during pregnancy or breastfeeding?
Sunitinib may harm an unborn baby and is not recommended during pregnancy or breastfeeding. Use effective contraception during treatment and discuss risks with your doctor.
How will my doctor monitor my treatment?
Your doctor will regularly check your blood pressure, heart function, liver and thyroid tests, and blood counts to monitor for side effects and adjust your treatment as needed.
What happens if I take too much Sunitinib?
Taking too much Sunitinib can lead to an exacerbation of side effects, potentially including severe fatigue, gastrointestinal issues, and cardiovascular complications. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Do not attempt to manage an overdose at home, as professional medical intervention may be required to stabilize your condition and mitigate serious health risks.
Can I drink alcohol while taking Sunitinib?
It is generally advisable to limit or avoid alcohol consumption while taking Sunitinib. Alcohol can potentially worsen some of the common side effects of Sunitinib, such as fatigue and gastrointestinal upset. Furthermore, both Sunitinib and alcohol are metabolized by the liver, and combining them could increase the strain on your liver, potentially leading to liver toxicity. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Sunitinib safe during pregnancy?
Sunitinib is generally not recommended during pregnancy due to potential risks to the developing fetus. It falls under a pregnancy category that indicates potential harm. Women of childbearing potential should use effective contraception during treatment and for a period after. If you are pregnant, planning to become pregnant, or suspect you might be pregnant, it is imperative to discuss this with your healthcare provider immediately to assess the risks and determine the most appropriate course of action.
What is the mechanism of action of sunitinib malate?
Sunitinib is a multi-targeted receptor tyrosine kinase inhibitor. It blocks several cellular receptors, including vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs), KIT, FLT3, and RET. By inhibiting these kinases, sunitinib disrupts tumor cell proliferation and angiogenesis, leading to reduced tumor growth and metastasis. (1)
What is the generic name of Sunitinib Malate?
The generic name is sunitinib malate. It is sold under brand names including Suninat, Sutent, Sutinat.
What class of drug is sunitinib malate?
Sunitinib Malate is classed as: Tyrosine kinase inhibitor (antineoplastic agent).
References
- Sunitinib — Prescribing InformationMedGuideGlobal (aggregated from DailyMed) · United States · accessed 2026-08-03 · source 1
- SUTENT (sunitinib malate) FDA-approved prescribing informationU.S. National Library of Medicine (DailyMed) · United States · accessed 2026-08-07 · source 2
- SUNITINIB MALATE CAPSULE [NORTHSTAR RXLLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Sunitinib Malate — FDA approval record (Drugs@FDA ANDA218012)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- sunitinib malate — RxNorm normalized drug concept (RXCUI 616275)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient sunitinib malate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- SUTENT37.5 mg, 12.5 mg, 50 mg, 25 mg · pfizer laboratories div pfizer inc