Vorasidenib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.

Usual Adult Dose for Brain/Intracranial Tumor

40 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of patients with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or -2 (IDH1 or IDH2) mutation after surgery including biopsy, subtotal resection, or gross total resection

Usual Pediatric Dose for Brain/Intracranial Tumor

12 years and older:

• Less than 40 kg: 20 mg orally once a day
• At least 40 kg: 40 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of patients with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation after surgery including biopsy, subtotal resection, or gross total resection

Renal Dose Adjustments

CrCl greater than 40 mL/min: No adjustment recommended
CrCl 40 mL/min or less: Frequent monitoring recommended

Comments:

• Pharmacokinetics and safety have not been studied in patients with CrCl 40 mL/min or less.
• Monitor patients with CrCl 40 mL/min or less for increased adverse reactions; modify dosage for adverse reactions as recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Frequent monitoring recommended

If Hepatotoxicity Develops During Therapy (Elevation of ALT or AST):
Dosage reductions for hepatotoxicity:

• Adult patients and pediatric patients 12 years and older weighing at least 40 kg:
• First reduction: 20 mg orally once a day
• Second reduction: 10 mg orally once a day
• Pediatric patients 12 years and older weighing less than 40 kg:
• First reduction: 10 mg orally once a day
• Permanently discontinue this drug in patients unable to tolerate 10 mg once a day.

Dosage modifications and management for hepatotoxicity:

• Grade 1, ALT or AST increase greater than the upper limit of normal (ULN) to 3 times ULN (3 x ULN) without concurrent total bilirubin greater than 2 x ULN: Continue therapy at current dose; monitor liver laboratory tests weekly until recovery to less than grade 1.
• Grade 2, ALT or AST greater than 3 to 5 x ULN without concurrent total bilirubin greater than 2 x ULN: Withhold therapy until recovery to grade 1 or less or baseline.
• First occurrence: If recovery in 28 days or less, resume therapy at the same dose; if recovery in greater than 28 days, resume therapy at reduced dose.
• Second occurrence: After recovery, resume therapy at reduced dose.
• Grade 3, ALT or AST greater than 5 to 20 x ULN without concurrent total bilirubin greater than 2 x ULN:
• First occurrence: Withhold therapy until recovery to grade 1 or less or baseline. If recovery in 28 days or less, resume therapy at reduced dose; if not recovered in 28 days or less, permanently discontinue this drug.
• Recurrence: Permanently discontinue this drug.
• Grade 2 or 3, any ALT or AST greater than 3 to 20 x ULN with concurrent total bilirubin greater than 2 x ULN:
• First occurrence: Withhold therapy until recovery to grade 1 or less or baseline. Resume therapy at reduced dose.
• Recurrence: Permanently discontinue this drug.
• Grade 4, any ALT or AST greater than 20 x ULN: Permanently discontinue this drug.

Comments:

• Pharmacokinetics and safety have not been studied in patients with severe liver dysfunction.
• Monitor patients with severe liver dysfunction for increased adverse reactions; modify dosage for adverse reactions as recommended.

Dose Adjustments

Dosage Reductions for Adverse Reactions:

• Adult patients and pediatric patients 12 years and older weighing at least 40 kg:
• First reduction: 20 mg orally once a day
• Second reduction: 10 mg orally once a day
• Pediatric patients 12 years and older weighing less than 40 kg:
• First reduction: 10 mg orally once a day
• Permanently discontinue this drug in patients unable to tolerate 10 mg once a day.

Dosage Modifications and Management for Adverse Reactions:

• Grade 3 adverse reactions (other than hepatotoxicity):
• First occurrence: Withhold this drug until recovery to grade 1 or less or baseline; resume therapy at reduced dose.
• Second occurrence: Permanently discontinue this drug.
• Grade 4 adverse reactions: Permanently discontinue this drug.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Frequent monitoring recommended

Comments:

• Pharmacokinetics and safety have not been studied in patients with renal dysfunction requiring dialysis.
• Monitor patients who require dialysis for increased adverse reactions; modify dosage for adverse reactions as recommended.

Other Comments

Administration advice:

• Before starting this drug, evaluate blood chemistry and liver laboratory tests.
• Select patients with grade 2 astrocytoma or oligodendroglioma for treatment based on the presence of IDH1 or IDH2 mutations in tumor specimens.
• Administer this drug at about the same time each day, with or without food.
• Swallow tablets whole with water; do not split, crush, or chew tablets.
• If a dose is missed, administer the missed dose as soon as possible within 6 hours; if a dose is missed by more than 6 hours, skip the missed dose and administer the next dose at the scheduled time.
• If vomiting occurs after administration of a dose, do not administer a replacement dose; administer the next dose at the scheduled time the following day.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

General:

• There is not a US FDA-approved test available for detection of IDH1 or IDH2 mutations in grade 2 astrocytoma or oligodendroglioma for selecting patients for treatment with this drug.

Monitoring:

• General: Blood chemistry (before starting therapy)
• Hepatic: Liver laboratory tests including ALT, AST, GGT, total bilirubin, and alkaline phosphatase (before starting therapy, every 2 weeks during first 2 months of therapy, then monthly for first 2 years of therapy, and as clinically indicated)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Promptly report any signs/symptoms of hepatotoxicity to your health care provider.
• Female patients of childbearing potential:
• Notify health care provider of a known/suspected pregnancy.
• Use effective nonhormonal contraception during therapy and for 3 months after the last dose.
• Male patients with female partners of childbearing potential: Use effective contraception during therapy and for 3 months after the last dose.
• Do not breastfeed during therapy and for 2 months after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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