Sulanda Surufatinib Capsules

1. Indications and Usage
Non-Pancreatic Neuroendocrine Tumors (npNETs):
Indicated for the treatment of adult patients with unresectable locally advanced or metastatic, progressive, non-functional, well-differentiated (G1/G2) non-pancreatic neuroendocrine tumors.
Pancreatic Neuroendocrine Tumors (pNETs):
Indicated for the treatment of adult patients with unresectable locally advanced or metastatic, progressive, non-functional, well-differentiated (G1/G2) pancreatic neuroendocrine tumors.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY.
Recommended Dosage:
Monotherapy: 300 mg (six 50 mg capsules) administered orally once daily.
Combination Therapy: 250 mg (five 50 mg capsules) administered orally once daily.
Duration: Continue daily for 4 weeks as one cycle until disease progression or unacceptable toxicity.
Administration Instructions:
Swallow capsules whole with water; do not crush or chew.
Can be taken on an empty stomach or with a low-calorie meal (approx. 500 kcal, 20% fat).
Missed Dose:
If a dose is missed, do not take it. Resume at the regularly scheduled time for the next dose. If vomiting occurs after administration, do not take an extra dose.
3. Mechanism of Action
Multi-kinase Inhibition:
Surufatinib is a small molecule tyrosine kinase inhibitor that targets three key receptors:
1. VEGFR1-3 (Vascular Endothelial Growth Factor Receptors): Inhibits tumor angiogenesis.
2. FGFR1-4 (Fibroblast Growth Factor Receptors): Inhibits tumor growth and survival.
3. CSF1R (Colony Stimulating Factor 1 Receptor): Modulates the tumor microenvironment by inhibiting M2 macrophage polarization.
4. Safety and Warnings
Proteinuria:
Monitor urine protein regularly. In case of severe proteinuria (≥ 3g/24h), treatment should be interrupted or dose-adjusted.
Hypertension:
Monitor blood pressure regularly. Initiate antihypertensive therapy as needed.
Bleeding Risk:
Monitor for signs of bleeding. Contraindicated in patients with severe active bleeding.
Hepatic Impairment:
Monitor liver function tests regularly. Contraindicated in patients with severe hepatic impairment.
5. Adverse Reactions
Most Common:
Proteinuria, hypertension, hyperbilirubinemia, diarrhea, hypoalbuminemia, hypertriglyceridemia, elevated ALT/AST, fatigue, abdominal pain, and peripheral edema.
6. Drug Interactions
CYP3A4 Modulators:
Surufatinib is metabolized by CYP3A4. Avoid concomitant use with strong CYP3A4 inhibitors or inducers.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Surufatinib (available in 50 mg and 100 mg strengths).
Storage:
Store in a tightly closed container in a dry place at a temperature not exceeding 30°C.