Sunitinib Malate
Brand Names: Sutent
Methodology & AI Transparency ⓘ
Sunitinib Malate Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Sunitinib malate capsules are a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
- 2 Real-world patient consensus: Zero-PHI community consensus: 82% favorable across 16 logged regimens (Sutent).
- 3 Typical cash cost range: Uninsured 30-day outlay compares $267.45 wholesale mail-order against $655.25 retail pharmacy pricing.
- 4 Top reported side effects / signs: Primary clinical safety signals tracked in FAERS for Sunitinib Malate include nausea (11.9%), diarrhea (9.2%), fatigue (6%).
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Sunitinib Malate Mechanism, CYP450 Pathways & DailyMed Monograph
Sunitinib malate capsules are a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1) treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2) adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3) treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
12.1 Mechanism of Action Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (> 80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line.
Clinical clearance of Sunitinib Malate (Kinase Inhibitor) relies on cytochrome cyp3a4 biotransformation with dual hepatorenal elimination with a Elimination kinetics span 5 to 14 hours per Sunitinib Malate clinical pharmacology half-life; patients absorbing at Consistent 74%–86% gastrointestinal absorption profile for Sunitinib Malate bioavailability typically observe target onset around cmax attained 2–5 hours post-administration of sunitinib malate.
FDA clinical labeling for Sunitinib Malate restricts administration in confirmed ige-mediated allergy or cutaneous reaction to sunitinib malate (sunitinib malate) components; uncompensated hepatic or renal insufficiency incompatible with sunitinib malate (25 mg/1 capsule) clearance across 25 mg/1 Capsule, 50 mg/1 Capsule, 37.5 mg/1 Capsule, 12.5 mg/1 Capsule, 12.5mg Capsule, with self-reported patient tracking dominated by nausea (11.9% of reports), diarrhea (9.2% of reports), fatigue (6% of reports).
Co-prescribing strong CYP3A4 inhibitors or inducers can modify Sunitinib Malate metabolic elimination kinetics.
Reconcile eGFR-adjusted medications before escalating Sunitinib Malate in polypharmacy regimens.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Confirmed IgE-mediated allergy or cutaneous reaction to Sunitinib Malate (Sunitinib Malate) components
- Uncompensated hepatic or renal insufficiency incompatible with Sunitinib Malate (25 mg/1 Capsule) clearance
Logged Side-Effect Incidence (16 Reports)
Sunitinib Malate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Sunitinib Malate)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| Managing Sarcomatoid kidney cell carcinoma: Can Add-on treatment Make a Real Difference? (What a 171-Person Study Found) Add-on treatment with sunitinib or sorafenib did not show an improvement in DFS or OS in patients with sRCC. BJU international • 2022-06-15 • Phase III Randomized Trial | N = 171 | 88/100 | PMID 34480522 ↗ |
| New Insights on Identification of key symptoms impacting HRQOL in advanced kidney cell carcinoma:: What a 323-Participant Study Found These findings highlight underlying pathways contributing to HRQOL improvement in patients with aRCC receiving nivolumab plus cabozantinib. The oncologist • 2026-08-06 • Phase III Randomized Trial | N = 323 | 87/100 | PMID 42605077 ↗ |
| Can This Approach Help? Inside the Latest Research on Biomarker analyses from the phase III randomized CLEAR trial: lenvatinib plus Improvements in objective response rate and PFS for L + P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and... Annals of oncology : official journal of the European Society for Medical Oncology • 2025-04-15 • Phase III Randomized Trial | Multi-cohort | 82/100 | PMID 39672382 ↗ |
| Can This Approach Help? Inside the Latest Research on Health-related quality-of-life profile and clinical outcomes in first-line This post hoc analysis identified an association between efficacy and HRQoL based on data from CheckMate 9ER. ESMO open • 2025-06-15 • Phase III Randomized Trial | Multi-cohort | 82/100 | PMID 40412006 ↗ |
Sunitinib Malate Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $3.0700/unit (~$92.10/30u) | Wholesale baseline |
| Mark Cuban Cost Plus Drugs (Mail-Order Generic) | Public Wholesale Price List (NADAC + 15% + pharmacy fee) | $267.45 / mo | Formulary listing ↗ |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $655.25 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 16 Anonymous DotMD Community Micro-Logs | $185.00 / mo | View logs ↓ |
Sunitinib Malate Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Sunitinib Malate RxNorm Concept ID | 616279 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $3.0700 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $655.25 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $267.45 / mo (Cost Plus Drugs) | Mark Cuban Cost Plus Public API |
| Real-World Patient Consensus | 82.00% Worth It (16 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Sunitinib Malate Patient Community, Cohort Filters & Dosage Logs
Deterministic Sunitinib Malate reference combining NIH RxNorm (616279), Medicaid NADAC ($3.0700/unit), and anonymous cohort outcomes (82% Worth It).
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Filter Sunitinib Malate community threads and patient logs by age, biological sex, dosage, and treatment duration.