WELIREG® FILM-COATED TABLET 40MG

1. INDICATIONS AND USAGE

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

1.2 Advanced Renal Cell Carcinoma (RCC)
WELIREG is indicated for the 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 (VEGF) targeted therapy.

3. CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

2. DOSAGE AND ADMINISTRATION

2.1 General
The recommended dose of WELIREG is 120 mg (three 40 mg tablets) administered orally once daily, with or without food. Swallow tablets whole.

If a dose of WELIREG is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for WELIREG the next day. Extra tablets should not be taken to make up for the missed dose. If vomiting occurs any time after taking WELIREG, do not retake the dose. The next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.

2.2 Dose Modifications

Dosage modifications for WELIREG for adverse reactions are summarized in Table 1.

2.3 Pediatric Patients
Safety and efficacy of WELIREG have not been established in pediatric patients less than 18 years of age [see 6. USE IN SPECIFIC POPULATIONS, 6.4 Pediatric Use and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.4 Geriatric Patients
No dose adjustment of WELIREG is recommended in elderly patients [see 6. USE IN SPECIFIC POPULATIONS, 6.5 Geriatric Use and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.5 Renal Impairment
No dose adjustment of WELIREG is recommended in patients with renal impairment including end-stage renal disease [see 6. USE IN SPECIFIC POPULATIONS, 6.6 Renal Impairment and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.6 Hepatic Impairment
No dose adjustment of WELIREG is recommended in patients with mild (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] > ULN or total bilirubin >1 to 1.5 x ULN and any AST) or moderate (total bilirubin within range of >1.5 x ULN and ≤ 3 x ULN and any AST or Child-Pugh B) hepatic impairment. WELIREG has not been studied in patients with severe hepatic impairment [see 6. USE IN SPECIFIC POPULATIONS, 6.7 Hepatic Impairment and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].