HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use LuciBelzu safely and effectively. See full prescribing information for LuciBelzu.

INDICATIONS AND USAGE

LuciBelzu is a hypoxia-inducible factor inhibitor indicated:

Von Hippel-Lindau (VHL) disease

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

Advanced Renal Cell Carcinoma (RCC)

• for treatment of adult patients with advanced renal cell carcinoma (RCC) following 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).

DOSAGE AND ADMINISTRATION 

The recommended dosage of LuciBelzu is 120 mg administered orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS 

Tablets: 40 mg×90 tablets

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

• Anemia: Monitor for anemia before initiation of and periodically throughout treatment with LuciBelzu.

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

• Hypoxia: Monitor oxygen saturation before initiation of, and periodically throughout, treatment with LuciBelzu. For hypoxia at rest, withhold until resolved, resume at reduced dose, or discontinue depending on severity. For life-threatening hypoxia, permanently discontinue LuciBelzu. 

ADVERSE REACTIONS 

VHL disease: Most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, fatigue,increased creatinine, headache, dizziness, increased glucose, and

nausea.

Advanced RCC: Most common (≥25%) adverse reactions, including laboratory abnormalities were 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 dosage of LuciBelzu as recommended.

USE IN SPECIFIC POPULATIONS 

• Lactation: Advise not to breastfeed. 

• Infertility: May impair fertility in males and females. 

Storage 

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.