Sutan Capsule 25 mg (Sunitinib Malate)

Adult dose

This medicine should be administered under the supervision of a physician experienced in the use of anticancer agents. 1. Gastrointestinal stromal tumor and advanced renal cell carcinoma The recommended dose of this medicine is 50 mg orally once daily for 4 weeks, followed by a 2-week rest period. Repeat treatment in 6-week cycles. This medicine may be taken with or without food. 2. Adjuvant treatment after surgery for renal cell carcinoma The recommended dose of this medicine for adjuvant treatment after surgery for renal cell carcinoma is 50 mg orally once daily for 4 weeks, followed by a 2-week rest period (4 weeks on treatment/2 weeks off treatment). Administer for 9 cycles of 6 weeks each. This medicine may be taken with or without food. 3. Pancreatic neuroendocrine tumors Administer 37.5 mg once daily without a rest period. It may be taken with or without food. 4. Dose and dosage adjustment 1) Based on individual safety and tolerability, dose increases or decreases in increments of 12.5 mg are recommended. For gastrointestinal stromal tumor and renal cell carcinoma, dose increases up to a maximum of 87.5 mg or decreases to a minimum of 25 mg are recommended. In the clinical trial of adjuvant treatment after surgery for renal cell carcinoma, the minimum dose administered was 37.5 mg. 2) Strong CYP3A4 inhibitors, such as ketoconazole, may increase the plasma concentration of this medicine. If replacing a concomitant medication, consider replacing it with another medication that has no or minimal potential for enzyme inhibition. If this medicine must be coadministered with a strong CYP3A4 inhibitor, consider reducing the dose to a minimum of 37.5 mg once daily (for gastrointestinal stromal tumor and advanced renal cell carcinoma) or 25 mg (for pancreatic neuroendocrine tumors). 3) Strong CYP3A4 inducers, such as rifampin, may decrease the plasma concentration of this medicine. If replacing a concomitant medication, consider replacing it with another medication that has no or minimal potential for enzyme induction. If this medicine must be coadministered with a strong CYP3A4 inducer, consider increasing the dose to a maximum of 87.5 mg once daily (for gastrointestinal stromal tumor and advanced renal cell carcinoma) or 62.5 mg (for pancreatic neuroendocrine tumors). If the dose is increased, carefully monitor the patient for potential toxicity. St. John's wort may decrease the plasma concentration of this medicine to an unpredictable extent. Patients receiving this medicine must not take St. John's wort concomitantly. 4) Temporary interruption of treatment may be necessary based on the individual patient's safety and tolerability.

This medication should be avoided by women who are pregnant or planning to become pregnant, as it may affect fetal vascular formation and carry the risk of malformations or fatal results. Patients with hypersensitivity to this drug should not take it, and various adverse reactions may occur during treatment, so caution is necessary. Common adverse reactions include fatigue, diarrhea, nausea, stomatitis, dyspepsia, vomiting, abdominal pain, constipation, and skin discoloration; serious cases may involve pulmonary embolism, thrombocytopenia, tumor bleeding, febrile neutropenia, hypertension, liver failure, and cardiac arrhythmias. Particularly, this drug can increase blood pressure, hence patients with hypertension should regularly monitor their blood pressure and receive appropriate treatment if necessary. Those with a history of cardiovascular disease require special caution. This medication may affect liver and kidney function, so regular testing is necessary for patients with liver or kidney diseases before and during administration. During administration, blood tests should frequently confirm blood cell counts to detect and manage blood abnormalities, such as thrombocytopenia or neutropenia, early. Patients may experience discoloration of skin or hair during medication, as well as skin symptoms such as dryness, rash, and erythematous sensory abnormalities of hands and feet. Additionally, this medication may infrequently cause severe side effects such as gastrointestinal perforation, pancreatitis, bleeding, necrotizing fasciitis, thrombotic microangiopathy, and jaw necrosis; if unusual symptoms occur, patients should consult their doctor immediately. This medication can interact with other drugs; therefore, it is essential to inform the doctor of all medications and health supplements taken, especially those that may affect CYP3A4 enzymes. Women of childbearing potential should avoid becoming pregnant while taking this medication, and nursing mothers should discontinue breastfeeding if using this medication. The safety and efficacy of this drug for children have not been established, and it may affect growth plates, so its use in pediatric patients is not recommended. Patients scheduled for surgery should temporarily stop taking this medication before major surgeries, as it may affect wound healing, and restart it after confirming recovery following surgery. During treatment, dizziness and drowsiness may occur, requiring caution while driving or operating machinery, and immediate consultation with healthcare providers is needed if there is a change in mental state or seizure symptoms.

• Pulmonary embolism
• thrombocytopenia
• tumor bleeding
• febrile neutropenia
• hypertension
• liver failure
• torsades de pointes
• fatigue
• diarrhea
• nausea

This medication must be stored in a tightly closed container to protect it from air and moisture. It is crucial to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance

A hard capsule with a brown upper part and an orange lower part containing yellow to orange granules

Package unit

28 capsules/bottle