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Multi-Targeted Receptor Tyrosine Kinase Inhibitor (VEGFR, PDGFR, KIT) Pregnancy: Contraindicated — embryotoxic and teratogenic; effective contraception required during and for 4 weeks after treatment

Sunitinib

Brand names: Sutent

Adult dose

Dose: 50 mg once daily for 4 weeks on, 2 weeks off (Schedule 4/2); alternative 37.5 mg continuous daily dosing in some protocols
Route: Oral
Frequency: Once daily (4 weeks on/2 weeks off)
Max: 62.5 mg/day
Metastatic RCC first-line (clear cell); GIST after imatinib failure; pNET; schedule 4/2 is most common; with or without food

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment required; haemodialysis: no established recommendation

Hepatic

Mild-moderate: no adjustment; severe: avoid — limited data

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • NEJM 2007 (Motzer et al.): sunitinib vs interferon-alfa in first-line mRCC — PFS 11 vs 5 months, ORR 31% vs 6%; established sunitinib as standard first-line for mRCC; largely superseded by nivolumab+ipilimumab or pembrolizumab+axitinib in intermediate/poor-risk disease
  • Hypertension management: VEGFR inhibition reduces nitric oxide production — BP rises in nearly all patients; treat aggressively (ACE inhibitors/ARBs preferred); avoid stopping sunitinib for hypertension alone if controllable; paradoxically, hypertension development may predict treatment response
  • Yellow skin discolouration: harmless — caused by sunitinib's yellow colour excreted in sweat; warn patients prospectively to avoid anxiety; hair and nails may also appear yellow/orange
  • Hypothyroidism: TSH should be checked every cycle; sunitinib causes thyroid destruction (thyroiditis) — cumulative incidence ~50% over 1 year; levothyroxine replacement often required; manage proactively
  • COMPARZ trial: pazopanib vs sunitinib in mRCC — non-inferior efficacy with different toxicity profile (better fatigue with pazopanib, less GI toxicity); patient preference and comorbidity guide selection; sunitinib preferred in pNET and GIST

Contraindications

  • Known hypersensitivity
  • Uncontrolled hypertension before starting

Side effects

  • Hypertension (monitor from day 1 — blood pressure often rises substantially)
  • Fatigue
  • Hand-foot syndrome (palmar-plantar erythrodysaesthesia)
  • Mucositis/stomatitis
  • Diarrhoea
  • Nausea
  • Hypothyroidism (common with prolonged use)
  • Hepatotoxicity
  • Haematotoxicity (cytopenias)
  • QTc prolongation
  • Yellow skin discolouration (benign — drug excretion in sweat)

Interactions

  • Strong CYP3A4 inhibitors (ketoconazole) — increase sunitinib levels; reduce dose to 37.5 mg
  • Strong CYP3A4 inducers (rifampicin) — reduce levels; increase dose to 87.5 mg
  • QTc-prolonging drugs — additive risk

Monitoring

  • Blood pressure (each visit — weekly initially)
  • TFTs (each cycle)
  • FBC, LFTs, electrolytes (each cycle)
  • Echocardiogram/LVEF (baseline and 3-monthly if cardiac history)
  • Hand-foot syndrome grading
  • PSA (if prostate cancer history)

Reference: BNFc; BNF 90; Motzer et al. NEJM 2007; COMPARZ trial (Motzer et al. NEJM 2013); NICE TA169; MHRA SPC Sutent; EAU RCC Guidelines 2024. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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