Suninitib capsules LuciSuni

Product Name: LuciSuni

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

Chinese Name: Sunitinib Capsules

English Name: Sunitinib Capsules

Specifications: 12.5 mg/capsule, 28 capsules/box | 25 mg/capsule, 28 capsules/box | 50 mg/capsule, 28 capsules/box

[Indications]

LuciSuni is a kinase inhibitor indicated for the treatment of:

Gastrointestinal stromal tumor (GIST) that has progressed or is intolerant to imatinib mesylate.

Advanced renal cell carcinoma (RCC).

Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

[Dosage and Administration]

GIST and RCC: 50 mg orally once daily, taken with or without food, for 4 weeks followed by a 2-week rest period.

pNET: 37.5 mg orally once daily, taken with or without food, administered continuously without a scheduled rest period.

Dose Adjustment: Based on individual safety and tolerability, dose interruption and/or dose adjustment in 12.5 mg increments is recommended.

[Contraindications] None.

[Warnings and Precautions]

Hepatotoxicity, including liver failure, has been observed. Monitor liver function tests prior to the start of treatment, during each treatment cycle, and as clinically indicated. For Grade 3 or 4 drug-related hepatic adverse events, LuciSuni treatment should be interrupted; if the event does not resolve, the drug should be discontinued. Do not restart LuciSuni if the patient subsequently experiences severe changes in liver function tests or develops other signs and symptoms of liver failure.

Women of reproductive potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant.

Cardiotoxicity, including a decrease in left ventricular ejection fraction to below the lower limit of normal and the occurrence of heart failure (including fatalities), has been observed. Monitor patients for signs and symptoms of congestive heart failure.

QT interval prolongation and Torsades de Pointes have been observed. Use with caution in patients at higher risk of QT interval prolongation. When using LuciSuni, consider monitoring ECG and electrolytes during treatment.

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

Hemorrhagic events, including tumor-related hemorrhage, have occurred. Perform serial complete blood cell counts and physical examinations.

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

It is recommended to temporarily interrupt LuciSuni treatment in patients undergoing major surgical procedures.

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

[Adverse Reactions]

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

[Drug Interactions]

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

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

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) are permitted. Protect from moisture.