Von Hippel-Lindau disease

Active Ingredient: Belzutifan

Indication for Belzutifan

Population group: only adults (18 - 65 years old)
Therapeutic intent: Curative procedure

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

For this indication, competent medicine agencies globally authorize below treatments:

120 mg once daily

For:

Dosage regimens

Oral, 120 milligrams belzutifan, once daily.

Detailed description

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 adverse reactions

Dosage modifications for belzutifan for adverse reactions are summarized in the table below.

The recommended dose reductions are:

  • First dose reduction: belzutifan 80 mg orally once daily
  • Second dose reduction: belzutifan 40 mg orally once daily
  • Third dose reduction: permanently discontinue.

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.

Dosage considerations

Belzutifan should be taken at the same time each day and may be taken with or without food.

Active ingredient

Belzutifan

Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α). Belzutifan binds to HIF-2α, and in conditions of hypoxia or impairment of VHL protein function, belzutifan blocks the HIF-2α-HIF-1β interaction, leading to reduced transcription and expression of HIF-2α target genes. In vivo, belzutifan demonstrated anti-tumor activity in mouse xenograft models of renal cell carcinoma.

Read more about Belzutifan

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