Active Ingredient: Belzutifan
Belzutifan 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 tyrosine kinase inhibitor (VEGF-TKI).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 120 milligrams belzutifan, once daily.
The recommended dosage is 120 mg administered orally once daily until disease progression or unacceptable toxicity.
If a dose of belzutifan is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for belzutifan the next day. Do not take extra tablets to make up for the missed dose.
If vomiting occurs any time after taking belzutifan, do not retake the dose. Take the next dose on the next day.
Dosage modifications for belzutifan for adverse reactions are summarized in the table below.
The recommended dose reductions are:
Recommended dosage modifications for adverse reactions:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Anemia | Hemoglobin <8 g/dL or transfusion indicated | • Withhold until hemoglobin ≥8g/dL. • Resume at the same or reduced dose; or discontinue depending on the severity of anemia. |
| Life-threatening or urgent intervention indicated | • Withhold until hemoglobin ≥8g/dL. • Resume at a reduced dose or permanently discontinue. | |
| Hypoxia | Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%) | • Consider withholding until resolved. • Resume at the same dose or at a reduced dose depending on the severity of hypoxia. |
| Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated | • Withhold until resolved. • Resume at reduced dose or discontinue depending on the severity of hypoxia. | |
| Life-threatening or recurrent symptomatic hypoxia | • Permanently discontinue. | |
| Other Adverse Reactions | 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. |
Belzutifan should be taken at the same time each day and may be taken with or without food.
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