Dosing
Dosing for WELIREG®▼ (belzutifan)
Prescribing Information [External Link]
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DosingOnce-daily, oral treatment
The recommended dose of WELIREG is 120 mg (three 40 mg tablets) administered orally once daily, with or without food.
Treatment should continue until disease progression or unacceptable toxicity.
Advise patients to swallow tablets whole
Tablets must not be chewed, crushed or split prior to swallowing.
If a dose is missed, it can be taken as soon as possible on the same day
The regular daily dose schedule 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, the dose should not be retaken
The next dose should be taken on the next day.
Manage adverse reactions with recommended dose modifications
Anaemia
| Severity* | Dose Modifications |
|---|---|
| Grade 3 Haemoglobin (Hgb < 8g /dL) transfusion indicated | Withhold until resolved to ≤ Grade 2 (Hgb ≥ 8 g/dL). Resume at a reduced dose (reduce by 40 mg) or discontinue depending on the severity and persistence of anaemia. |
| Grade 4 Life-threatening or urgent intervention indicated | Withhold until resolved to ≤ Grade 2 (Hgb ≥ 8 g/dL). Resume at a reduced dose (reduce by 40 mg) or permanently discontinue. |
Hypoxia
| Severity* | Dose Modifications |
|---|---|
| Grade 2 Decreased oxygen saturation with exercise (e.g. pulse oximeter < 88%) intermittent supplemental oxygen | Consider withholding until resolved. Resume at the same dose or at a reduced dose depending on the severity of hypoxia. |
| Grade 3 Decreased oxygen saturation at rest (e.g. pulse oximeter < 88% or PaO2 <= 55 mm Hg) | Withhold until resolved to ≤ Grade 2. Resume at a reduced dose (reduce by 40 mg) or discontinue depending on the severity and persistence of hypoxia. |
| Grade 4 Life-threatening | Permanently discontinue. |
Other Adverse Reactions
| Severity* | Dose Modifications |
|---|---|
| Grade 3 | Withhold dosing until resolved to ≤ Grade 2. Consider resuming at a reduced dose (reduce by 40 mg). 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 4.0.
Please refer to the Summary of Product Characteristics before prescribing.
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References
- WELIREG Summary of Product Characteristics.
Indication
WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable.
