Multi-Targeted Receptor Tyrosine Kinase Inhibitor (VEGFR, PDGFR, KIT) Pregnancy: Sunitinib should not be used during pregnancy or in women not using effective contraception unless the potential benefit justifies the potential risk to the foetus; studies in animals have shown reproductive toxicity including foetal malformations. Women of childbearing potential should use effective contraception and avoid becoming pregnant during treatment. Women should not breast-feed while taking sunitinib.

Sunitinib

Brand names: Sutent

Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used as an anticancer treatment, including for advanced renal cell carcinoma, under specialist supervision.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 50 mg

Route: Oral — may be taken with or without food

Frequency: Once daily for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2), comprising a complete cycle of 6 weeks

Max: Daily dose should not exceed 75 mg nor be decreased below 25 mg (GIST and MRCC)

INDICATION: the 50 mg Schedule 4/2 regimen above is the SPC dose for GIST and metastatic renal cell carcinoma (MRCC). OTHER INDICATION: for pNET the recommended dose is 37.5 mg orally once daily without a scheduled rest period (maximum dose administered in the Phase 3 pNET study was 50 mg daily). DOSE ADJUSTMENT: for GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability; for pNET, dose modification in 12.5 mg steps may be applied. Dose interruptions may be required based on individual safety and tolerability. CYP3A4: co-administration with potent CYP3A4 inducers (such as rifampicin) should be avoided — if not possible the sunitinib dose may need to be increased in 12.5 mg steps, up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET, with careful monitoring of tolerability. Co-administration with potent CYP3A4 inhibitors (such as ketoconazole) should be avoided — if not possible the dose may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET. MISSED DOSE: do not give an additional dose; the patient should take the usual prescribed dose the following day. HEPATIC IMPAIRMENT: no starting dose adjustment for mild or moderate (Child-Pugh A and B) impairment; not studied in severe (Child-Pugh C) impairment and its use there cannot be recommended. ELDERLY: no significant differences in safety or efficacy observed between younger and older patients. PAEDIATRIC: the safety and efficacy of sunitinib in patients below 18 years of age have not been established and no recommendation on a posology can be made. SOURCE NOTE: the eMC §4.4 and §4.8 sections in this bundle are truncated at the source-fetch limit, and no eMC §4.5 interactions section was retrieved — interaction entries below are drawn from eMC §4.2 and, where tagged, the US prescribing information in the same bundle.

Dose adjustments

Renal

No starting dose adjustment is required in patients with renal impairment (mild to severe) or with end-stage renal disease (ESRD) on haemodialysis; subsequent dose adjustments should be based on individual safety and tolerability.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Gastrointestinal disorders — diarrhoea, nausea, stomatitis, dyspepsia and vomiting (among the most common of any grade)
Fatigue, decreased appetite and taste disturbance
Hypertension
Skin discolouration and palmar-plantar erythrodysaesthesia syndrome
Haematological disorders — neutropenia, thrombocytopenia and anaemia (among the most common adverse drug reactions)
Hypothyroidism (may develop during treatment). Most serious reactions, some fatal: renal failure, heart failure, pulmonary embolism, gastrointestinal perforation and haemorrhages (respiratory tract, gastrointestinal, tumour, urinary tract and brain)

Interactions

Potent CYP3A4 inducers (e.g. rifampicin) — avoid co-administration; they may decrease sunitinib plasma concentration. If unavoidable, the sunitinib dose may need to be increased in 12.5 mg steps (eMC §4.2/§4.4)
Potent CYP3A4 inhibitors (e.g. ketoconazole) — avoid co-administration; they may increase sunitinib plasma concentration. If unavoidable, the sunitinib dose may need to be reduced (eMC §4.2/§4.4)
Anticoagulants (e.g. warfarin, acenocoumarol) — patients on concomitant anticoagulation may be periodically monitored by complete blood counts (platelets), coagulation factors (PT/INR) and physical examination (eMC §4.4)
Medicinal products known to prolong the QT interval — sunitinib is associated with QTc interval prolongation; monitor the QT interval with ECGs more frequently (US label §7.2)

Clinical monograph

How it works

It inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors and platelet-derived growth factor receptors, producing antiangiogenic and antitumour effects.

Prescribing in practice

It can cause serious cardiovascular toxicity, including hypertension, reductions in left ventricular ejection fraction and QT-interval prolongation, requiring careful baseline assessment and ongoing monitoring.
It must be prescribed and managed only by clinicians experienced in the use of anticancer agents, with attention to numerous drug interactions including potent CYP3A4 inhibitors and inducers.
Hand-foot skin reaction, hypothyroidism, bleeding and hepatotoxicity are recognised adverse effects that may require dose modification or interruption.

Monitoring

Monitor blood pressure, full blood count, liver function and thyroid function regularly, with cardiac assessment as clinically indicated.

Counselling the patient

Attend for regular blood pressure and blood test monitoring as arranged.
Report unusual bruising or bleeding, breathlessness, or painful redness and blistering of the hands and feet.
Effective contraception is needed because the drug can harm a developing baby.

Evidence & guidelines

Sunitinib's use in renal cell carcinoma is supported by NICE appraisal and pivotal trial evidence; follow the SPC and specialist protocols.

Reference: Motzer et al. NEJM 2007; COMPARZ trial (Motzer et al. NEJM 2013); NICE TA169; MHRA SPC Sutent; EAU RCC Guidelines 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways