Belzutifan

NO UK SPC (eMC) POSOLOGY WAS RETRIEVED FOR THIS DRUG — the whole record below is from US labelling (openFDA/DailyMed, WELIREG, Merck Sharp & Dohme LLC, label date 2026-06-12, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=120e5731-72fe-484f-ace4-5db35454a286). UK dosing must be confirmed against the UK SPC before publication. INDICATIONS AND REGIMENS (all 120 mg orally once daily in adults): von Hippel-Lindau disease — until disease progression or unacceptable toxicity; adjuvant treatment of ccRCC — in combination with pembrolizumab (or pembrolizumab and berahyaluronidase alfa-pmph), until disease recurrence or unacceptable toxicity or up to 54 weeks; treatment of advanced ccRCC — until disease progression or unacceptable toxicity; phaeochromocytoma or paraganglioma (PPGL) — until disease progression or unacceptable toxicity. PAEDIATRIC (weight-band, NOT per kg — verbatim from the US label): 'The recommended dosage of WELIREG in pediatric patients 12 years and older is based on bodyweight: Patients weighing 40 kg or greater: 120 mg orally once daily; Patients weighing less than 40 kg: 80 mg orally once daily' — this applies to the PPGL indication only. Safety and effectiveness have NOT been established in paediatric patients with VHL or ccRCC, or in patients younger than 12 years with PPGL. MISSED DOSE: may be taken as soon as possible on the same day; resume the regular daily schedule the next day and do not take extra tablets to make up a missed dose. If vomiting occurs at any time after taking a dose, do not retake it — take the next dose the next day. DOSE REDUCTIONS: first reduction 80 mg once daily; second reduction 40 mg once daily; third reduction — permanently discontinue. ANAEMIA (adjuvant ccRCC indication): haemoglobin <9 g/dL or transfusion indicated — withhold until haemoglobin ≥9 g/dL, then resume at the same or a reduced dose, or discontinue depending on severity. ANAEMIA (all other indications): haemoglobin <8 g/dL or transfusion indicated — withhold until haemoglobin ≥8 g/dL, then resume at the same or a reduced dose, or discontinue depending on severity; for life-threatening anaemia or where urgent intervention is indicated, resume at a reduced dose once resolved or permanently discontinue. HYPOXIA: decreased oxygen saturation with exercise (e.g. pulse oximeter <88%) — consider withholding until resolved, then resume at the same or reduced dose; decreased oxygen saturation at rest (pulse oximeter <88% or PaO2 ≤55 mmHg) or urgent intervention indicated — withhold until resolved, then resume at a reduced dose or discontinue depending on severity; life-threatening or recurrent symptomatic hypoxia — permanently discontinue. OTHER ADVERSE REACTIONS: Grade 3 — withhold until resolved to ≤Grade 2, consider resuming at a reduced dose (reduce by 40 mg), and permanently discontinue on recurrence of Grade 3; Grade 4 — permanently discontinue. MONITORING: check haemoglobin and oxygen saturation before starting and periodically throughout treatment. The §5, §7 and §8 texts were truncated at the source-fetch limit; no renal or hepatic dose-adjustment guidance was present in the fetched sections — clinician to source separately.