Sunitinib 12.5 mg is used to treat gastrointestinal stromal tumors (GIST) that have progressed after or are intolerant to imatinib mesylate.

Sunitinib Capsules (LuciSuni) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciSuni

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Sunitinib capsules

English name: Suninitib capsules

Drug approval number: 08 L 1166/24 (12.5mg)

【Indications】

LuciSuni is a kinase inhibitor indicated for the treatment of:

• Gastrointestinal stromal tumor (GIST) with disease progression or intolerance to imatinib mesylate.

• Advanced renal cell carcinoma (RCC).

• Advanced, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable locally advanced or metastatic disease.

 

【Usage and Dosage】

GIST and RCC:

• Take orally once a day, 50 mg each time, on an empty stomach or with a meal, and rest for 2 weeks after 4 weeks of treatment.

pNET:

• Take orally once daily, 37.5 mg each time, either on an empty stomach or with a meal, continuously, with no scheduled rest period.

Dosage adjustments:

• Dose interruption and/or dose adjustment to 12.5 mg is recommended based on individual safety and tolerability.

 

【Specification】

12.5mg/pill, 28 pills/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Hepatotoxicity, including hepatic failure, has been observed. Monitor liver function tests prior to initiation of treatment, during each cycle of treatment, and as clinically indicated. LuciSuni treatment should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not restart LuciSuni if ​​the patient subsequently develops severe changes in liver function tests or other signs and symptoms of hepatic failure.

•Women of childbearing age should be informed of the potential hazard to the fetus and to avoid pregnancy.

• Cardiac toxicity, including a decrease in left ventricular ejection fraction below the lower limit of normal and development of heart failure, including death. Monitor patients for signs and symptoms of congestive heart failure.

• QT prolongation and torsade de pointes have been observed. Use with caution in patients at increased risk for QT prolongation. Consider monitoring ECGs and electrolytes during treatment when using LuciSuni.

• Hypertension may occur. Monitor blood pressure and treat as needed.

•Bleeding events, including tumor-related bleeding, have occurred. Perform serial complete blood counts and physical examinations.

•Thyroid dysfunction may occur. Patients with signs and/or symptoms of hypothyroidism or hyperthyroidism should have thyroid function laboratory monitoring and be treated according to standard medical practice.

• Patients undergoing major surgical procedures are advised to temporarily interrupt LuciSuni treatment.

•Adrenal hemorrhage has been observed in animal studies. Monitor adrenal function during stressful situations such as surgery, trauma, or severe infection.

 

【Adverse Reactions】

• The most common adverse reactions (≥20%) are fatigue, asthenia, pyrexia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, taste changes, headache, back pain, arthralgia, pain in extremity, cough, dyspnea, anorexia, and hemorrhage.

 

【Drug Interactions】

•CYP3A4 Inhibitors: Consider reducing the dose of LuciSuni when administered with strong CYP3A4 inhibitors.

•CYP3A4 Inducers: Consider increasing the dose of LuciSuni when co-administered with CYP3A4 inducers.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.