Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
The recommended dose of WELIREG is 120 mg belzutifan (three 40 mg tablets) administered once daily, at the same time every day.
Treatment should continue until disease progression or unacceptable toxicity occurs.
If a dose of WELIREG is missed, it can be taken as soon as possible on the same day. The regular daily dose should be resumed the next day. Extra tablets should not be taken to make up for the missed dose.
If vomiting occurs any time after taking WELIREG, another dose should not be taken. The next dose should be taken the next day.
Dose modifications for WELIREG for adverse reactions are summarised in Table 1.
Table 1. Recommended dose modifications:
| Adverse reactions | Severity* | Dose modification |
|---|---|---|
| Anaemia (see section 4.4) | Grade 3 (haemoglobin < 8 g/dL; < 4.9 mmol/L; < 80 g/L; transfusion indicated) | • Withhold until resolved to ≤ Grade 2 • Resume at the same or reduced dose (reduce by 40 mg); consider discontinuing depending on the severity and persistence of anaemia |
| Grade 4 (life- threatening consequences or urgent intervention indicated) | • Withhold until resolved to ≤ Grade 2 • Resume at a reduced dose (reduce by 40 mg) or permanently discontinue upon recurrence of Grade 4 | |
| Hypoxia (see section 4.4) | Grade 3 asymptomatic (decreased oxygen saturation at rest (e.g., pulse oximeter < 88% or Pa O2 ≤ 55 mm Hg)) | • Option to continue or withhold until resolved to ≤ Grade 2 • Resume at reduced dose (reduce by 40 mg) or discontinue depending on the severity and persistence of hypoxia |
| Grade 3 symptomatic (decreased oxygen saturation at rest (e.g., pulse oximeter < 88% or Pa O2 ≤ 55 mm Hg)) | • Withhold until resolved to ≤ Grade 2 • Resume at reduced dose (reduce by 40 mg) or discontinue depending on the severity and persistence of hypoxia | |
| Grade 4 (life- threatening airway compromise; urgent intervention needed (e.g., tracheotomy or intubation)) | • Permanently discontinue | |
| Other adverse reactions (see section 4.8) | Grade 3 | • Withhold dosing until resolved to ≤ Grade 2 • Consider resuming at a reduced dose (reduce by 40 mg) depending on the severity and persistence • Permanently discontinue upon recurrence of Grade 3 |
| Grade 4 | • Permanently discontinue |
* Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
No dose adjustment is recommended in elderly patients (see section 5.2).
No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (see section 5.2).
No dose adjustment 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. Belzutifan has not been studied in patients with severe hepatic impairment (see section 5.2).
The safety and efficacy in children less than 18 years of age have not been established (see section 5.1). No data are available.
WELIREG is for oral use.
The tablets should be swallowed whole and may be taken with or without food. Tablets should not be split, crushed or chewed, as it is not known whether this impacts absorption of belzutifan.
There is no specific treatment for belzutifan overdose. In cases of susp ected overdose, if necessary, withhold belzutifan and institute supportive care. The highest dose of belzutifan studied clinically was 240 mg total daily dose (120 mg twice a day or 240 mg once a day). Grade 3 hypoxia occurred at 120 mg twice a day and Grade 4 thrombocytopenia occurred at 240 mg once daily.
4 years.
This medicinal product does not require any special storage conditions.
Aluminium/aluminium blisters.
Pack containing 30 film-coated tablets.
Multipack containing 90 (3 packs of 30) film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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