贝组替凡 1、希佩尔-林道综合征 (VHL)：贝组替凡适用于治疗相关肾细胞癌 (RCC)、中枢神经系统 (CNS) 血管母细胞瘤或胰腺神经内分泌肿瘤 (pNET) 的成年希佩尔-林道综合征 (VHL) 患者，无需立即手术。

LuciBelzu Tablets (LuciBelzu) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciBelzu

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

Chinese name: Beizutifan tablets

English name: Belzutifan tablets

Drug approval number: 08 L 1187/24

【Indications】

LuciBelzu is a hypoxia-inducible factor inhibitor indicated for:

Von Hippel-Lindau (VHL) disease

•For the treatment of adult patients with von Hippel-Lindau (VHL) disease who require treatment for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, or pancreatic neuroendocrine tumors (pNET) and who do not require immediate surgery.

Advanced renal cell carcinoma

•For adult patients with advanced renal cell carcinoma (RCC) following treatment with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

【Usage and Dosage】

The recommended dose of LuciBelzu is 120 mg once daily, which can be taken with or without food.

【Specification】

40mg/tablet, 90 tablets/box.

【Contraindications】

none

【Warnings and precautions】

•Anemia: Monitor for anemia prior to initiating LuciBelzu and periodically throughout treatment.

• Withhold LuciBelzu until hemoglobin ≥8 g/dL, then resume at the same or reduced dose or discontinue. For life-threatening anemia, or anemia requiring urgent intervention, withhold LuciBelzu until hemoglobin ≥8 g/dL and resume at a reduced dose or permanently discontinue LuciBelzu.

• Hypoxia: Monitor oxygen saturation prior to initiating LuciBelzu treatment and periodically throughout treatment. For hypoxia at rest, withhold until resolved, resume at reduced dose, or discontinue based on severity. For life-threatening hypoxia, permanently discontinue LuciBelzu.

【Adverse Reactions】

VHL Disease: The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased blood glucose, and nausea.

Advanced Renal Cell Carcinoma: The most common adverse reactions (≥25%), including laboratory abnormalities, included decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.

【Drug Interactions】

UGT2B17 or CYP2C19 Inhibitors: Monitor for signs and symptoms of anemia and hypoxia and reduce the dose of LuciBelzu as recommended.

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

•Infertility: May impair fertility in both men and women.

【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.