Vorasidenib Dosage

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

Applies to the following strengths: 40 mg; 10 mg

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.