Sunitinib Malate Capsules Sutinat

[Product Name] Sunitinib Capsules

[Other Names] Sutent

[English Name] Sunitinib Capsules

[Specification] 12.5 mg × 28 capsules/box; 25 mg × 28 capsules/box; 50 mg × 28 capsules/box

[Manufacturer] Natco Pharmaceuticals

[Indications]

Sunitinib is indicated for the treatment of the following malignant tumors:

Advanced Renal Cell Carcinoma (Kidney Cancer):

As a first-line therapy for advanced or metastatic renal cell carcinoma.

Gastrointestinal Stromal Tumor (GIST):

For patients with gastrointestinal stromal tumors that are refractory to, or who are intolerant of, Imatinib treatment.

Pancreatic Neuroendocrine Tumors (pNET):

For unresectable, locally advanced, or metastatic pancreatic neuroendocrine tumors.

[Dosage and Administration]

The dosage and administration of Sunitinib vary depending on the specific indication, the individual patient's condition, and other factors, as detailed below:

Standard Dosage and Administration

Gastrointestinal Stromal Tumor and Advanced Renal Cell Carcinoma

The recommended dose is 50 mg, taken orally once daily.

It is administered according to a "4/2" dosing schedule: 4 weeks of treatment followed by a 2-week rest period. This constitutes one 28-day treatment cycle.

Pancreatic Neuroendocrine Tumors

The recommended dose is 37.5 mg, taken orally once daily.

It is administered continuously without a scheduled rest period; treatment is maintained daily at this dose.

Adjuvant Therapy for Renal Cell Carcinoma

The recommended dose is 50 mg, taken orally once daily.

It is administered for 4 weeks followed by a 2-week rest period; each 6-week period constitutes one treatment cycle, for a total of 9 such cycles.

Dosage Adjustment

Adjustments due to Adverse Reactions: During treatment, if Grade 3 or 4 drug-related adverse reactions occur, administration should be temporarily suspended. Once the adverse reactions have resolved to Grade ≤1 or returned to baseline levels, treatment may be resumed at a reduced dose. The initial dose reduction may be adjusted to 37.5 mg once daily; if a further reduction is required, the dose may be reduced to 25 mg once daily; if a further reduction is again required, the dose may be reduced to 12.5 mg once daily.

Patients with Hepatic or Renal Impairment: Patients with mild hepatic or renal impairment generally do not require dose adjustment. For patients with moderate hepatic impairment, a dose reduction should be considered, with a recommended starting dose of 37.5 mg once daily. Data regarding patients with severe hepatic impairment are limited; therefore, the drug should be used with caution in this population. Patients with renal impairment generally do not require dose adjustment based on renal function; however, for patients with end-stage renal disease (ESRD) undergoing dialysis, adequate data are currently lacking, and close monitoring is advised during use.

Patients must strictly adhere to their physician's advice and prescription when taking Sunitinib; they should not arbitrarily adjust the dosage or administration regimen on their own.

【Pharmacological Actions】

Mechanism of Action: Sunitinib is a multi-targeted tyrosine kinase inhibitor that exerts its effects by inhibiting the following targets:

Vascular Endothelial Growth Factor Receptor (VEGFR)

Platelet-Derived Growth Factor Receptor (PDGFR)

Stem Cell Factor Receptor (KIT)

FMS-like Tyrosine Kinase 3 (FLT3)

Colony-Stimulating Factor Receptor 1 (CSF-1R)

Retinoblastoma Gene (RET)

Therapeutic Effects: Inhibits tumor angiogenesis, blocks tumor cell proliferation, and induces tumor cell apoptosis.

【Side Effects】

Sunitinib may cause the following common side effects:

Hematologic System: Neutropenia, thrombocytopenia, anemia.

Gastrointestinal System: Diarrhea, nausea, vomiting, stomatitis, dyspepsia.

Dermatologic Reactions: Hand-foot syndrome, rash, skin discoloration.

Cardiovascular System: Hypertension, left ventricular dysfunction.

Other: Fatigue, hypothyroidism, proteinuria.

【Precautions】

Monitoring of Complete Blood Count (CBC):

During treatment, complete blood counts (CBC) must be monitored regularly, with particular attention to neutrophil and platelet counts.

Blood Pressure Management:

Treatment may induce hypertension; therefore, blood pressure should be monitored regularly, and appropriate measures should be taken to control it. Thyroid Function:

May cause hypothyroidism; thyroid function should be monitored periodically.

Hepatic and Renal Function:

Hepatic and renal function should be monitored prior to and during treatment.

Pregnancy and Lactation:

Contraindicated in pregnant women; women who are breastfeeding must discontinue nursing.

Drug Interactions:

Avoid concomitant use with potent CYP3A4 inhibitors or inducers to prevent alterations in drug concentrations.

[Contraindications]

Contraindicated in patients with hypersensitivity to sunitinib or to any of the excipients.

Contraindicated in pregnant women.

[Storage Conditions]

Store below 30°C; protect from light and moisture.

Keep the medication in its original packaging; keep out of reach of children.