Voranigo Dosage

Generic name: vorasidenib 10mg
Dosage form: tablet, film coated
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Apr 8, 2025.

Recommended Evaluation Before Initiating VORANIGO

Before initiating VORANIGO, evaluate blood chemistry and liver laboratory tests.

Patient Selection

Select patients with Grade 2 astrocytoma or oligodendroglioma for treatment with VORANIGO based on the presence of IDH1 or IDH2 mutations in tumor specimens.

Information on FDA-approved tests for detection of IDH1 or IDH2 mutations in Grade 2 astrocytoma or oligodendroglioma for selecting patients for treatment with VORANIGO is available at: https://www.fda.gov/CompanionDiagnostics.

Recommended Dosage and Administration

Recommended Dosage

Adult Patients

The recommended dosage of VORANIGO in adult patients is 40 mg orally once daily until disease progression or unacceptable toxicity.

Pediatric Patients 12 Years and Older

The recommended dosage of VORANIGO in pediatric patients 12 years and older is based on body weight:

Patients weighing ≥40 kg: 40 mg orally once daily
Patients weighing <40 kg: 20 mg orally once daily

Continue treatment with VORANIGO until disease progression or unacceptable toxicity.

Administration

Swallow VORANIGO tablets whole with water with or without food. Do not split, crush or chew tablets.

Missed Dose

Take VORANIGO tablets at about the same time each day. If a dose is missed, take 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 take the next dose at the scheduled time.

Vomiting

If vomiting occurs after taking a dose, do not take a replacement dose, and take the next dose at the scheduled time on the following day.

Dosage Modifications, Management and Monitoring for Adverse Reactions

The recommended VORANIGO dosage reductions for adverse reactions are provided in Table 1.

Table 1: Recommended VORANIGO Dosage Reductions for Adverse Reactions
Dosage Reduction	Recommended Dose and Schedule
Adult patients and Pediatric patients 12 years and older weighing at least 40 kg
First	20 mg once daily
Second	10 mg once daily
Pediatric patients 12 years and older weighing less than 40 kg
First	10 mg once daily
Permanently discontinue VORANIGO in patients unable to tolerate 10 mg once daily.

The recommended management for adverse reactions and VORANIGO dosage modifications for adverse reactions are provided in Table 2.

Table 2: Recommended VORANIGO Dosage Modifications and Management for Adverse Reactions
Adverse Reaction	Severity*	Management and Dosage Modifications
Abbreviations: ALT = Alanine aminotransferase; AST = Aspartate aminotransferase; ULN = Upper limit of normal
* Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Hepatotoxicity (Elevation of ALT or AST)	Grade 1 ALT or AST increase >ULN to 3 × ULN without concurrent total bilirubin >2 × ULN	Continue VORANIGO at current dose. Monitor liver laboratory tests weekly until recovery to <Grade 1.
	Grade 2 ALT or AST >3 to 5 × ULN without concurrent total bilirubin >2 × ULN	First Occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline. Recovery in ≤28 days, resume VORANIGO at the same dose. Recovery in >28 days, resume VORANIGO at reduced dose. Recurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline, and resume VORANIGO at reduced dose.
	Grade 3 ALT or AST >5 to 20 × ULN without concurrent total bilirubin >2 × ULN	First Occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline. Recovery in ≤28 days, resume VORANIGO at reduced dose. If not recovered in ≤28 days, permanently discontinue VORANIGO. Recurrence: Permanently discontinue VORANIGO.
	Grade 2 or 3 Any ALT or AST >3 to 20 × ULN with concurrent total bilirubin >2 × ULN	First Occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline. Resume VORANIGO at reduced dose. Recurrence: Permanently discontinue VORANIGO.
	Grade 4 Any ALT or AST >20 × ULN	Permanently discontinue VORANIGO.
Other Adverse Reactions	Grade 3	First Occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline. Resume VORANIGO at reduced dose. Recurrence: Permanently discontinue VORANIGO.
Other Adverse Reactions	Grade 4	Permanently discontinue VORANIGO.