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VORANIGO® dosing and administration

Voranigo (vorasidenib) tablets

VORANIGO is administered orally as a once-daily tablet1

The recommended dosage of VORANIGO:

Adult patients
  • 40 mg orally once daily until disease progression or unacceptable toxicity
Pediatric patients 12 years and older
  • Patients weighing ≥40 kg, take 40 mg orally once daily
  • Patients weighing <40 kg, take 20 mg orally once daily
Swallow tablets whole with water with or without food
Do not split, crush, or chew tablets
Voranigo (vorasidenib) tablets

Continue VORANIGO until disease progression or unacceptable toxicity.

Take VORANIGO tablets at about the same time each day. If a dose is missed by less than 6 hours, 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 usual time.

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.


Monitoring and dose modifications

Initial assessment and continued monitoring for treatment with VORANIGO.

Before initiating VORANIGO1:

  • Evaluate blood chemistry and liver laboratory tests
  • Verify pregnancy status in females of reproductive potential

During treatment with VORANIGO1:

  • Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment and then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations
  • Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity

Pregnancy and fertility considerations1:

  • Based on animal embryo-fetal toxicity studies, VORANIGO can cause fetal harm when administered to pregnant women
  • Based on findings in animals, VORANIGO may impair fertility in females and males of reproductive potential. The effects on female and male fertility were not reversible in rats
  • Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose. VORANIGO can render some hormonal contraceptives ineffective
  • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose
  • Because of the potential for adverse reactions in breastfed children from VORANIGO, advise women not to breastfeed during treatment with VORANIGO and for 2 months after the last dose

The VORANIGO USPI does not include recommendations for electrocardiogram monitoring before or during treatment.1

Recommended VORANIGO dosage reductions for adverse reactions (ARs)1


Adjustments to monitoring and dosing due to ARs

Additional blood counts, including liver laboratory tests, and dose modifications are recommended for increases in ALT, AST, and total bilirubin.1

Recommended dosage modifications and management for ARs1

Hepatotoxicity (Elevation of ALT or AST)

Adverse reaction
Severitya Management and dosage modifications
Hepatotoxicity
(Elevation of ALT or AST)
Grade 1
ALT or AST increase >ULN to 3 x ULN without concurrent total bilirubin >2 x ULN
Continue VORANIGO at current dose
Monitor liver laboratory tests weekly until recovery to <Grade 1
Grade 2
ALT or AST >3 to 5 x ULN without concurrent total bilirubin >2 x 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
  • See dosage reduction info
Recurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline, and resume VORANIGO at reduced dose
See dosage reduction info
Grade 3
ALT or AST >5 to 20 x ULN without concurrent total bilirubin >2 x ULN
First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
  • Recovery in ≤28 days, resume VORANIGO at reduced dose
  • See dosage reduction info
  • If not recovered in ≤28 days, permanently discontinue VORANIGO
Recurrence: Permanently discontinue VORANIGO
Grade 2 or 3
ALT or AST >3 to 20 x ULN with concurrent total bilirubin >2 x ULN
First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
Recurrence: Permanently discontinue VORANIGO
Grade 4
Any ALT or AST >20 x ULN
Permanently discontinue VORANIGO
Other ARs
Grade 3 First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
Recurrence: Permanently discontinue VORANIGO
Grade 4 Permanently discontinue VORANIGO
Severitya Management and dosage modifications
Grade 1
ALT or AST increase >ULN to 3 x ULN without concurrent total bilirubin >2 x ULN
Continue VORANIGO at current dose
Monitor liver laboratory tests weekly until recovery to <Grade 1
Grade 2
ALT or AST >3 to 5 x ULN without concurrent total bilirubin >2 x 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
See dosage reduction info
Recurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline, and resume VORANIGO at reduced dose
See dosage reduction info
Grade 3
ALT or AST >5 to 20 x ULN without concurrent total bilirubin >2 x ULN
First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
  • Recovery in ≤28 days, resume VORANIGO at reduced dose
  • See dosage reduction info
  • If not recovered in ≤28 days, permanently discontinue VORANIGO
Recurrence: Permanently discontinue VORANIGO
Grade 2 or 3
ALT or AST >3 to 20 x ULN with concurrent total bilirubin >2 x ULN
First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
Recurrence: Permanently discontinue VORANIGO
Grade 4
Any ALT or AST >20 x ULN
Permanently discontinue VORANIGO
Other ARs
Severitya Management and dosage modifications
Grade 3 First occurrence: Withhold VORANIGO until recovery to ≤Grade 1 or baseline
Recurrence: Permanently discontinue VORANIGO
Grade 4 Permanently discontinue VORANIGO

aARs graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Dosing changes to VORANIGO in INDIGO

The median duration of exposure to VORANIGO was 12.7 months (range: 1 to 30 months).1

Duration of exposure to VORANIGO Number of patients
≥6 months 153 (92%)
≥1 year 89 (53%)

Dosage interruptions and discontinuations in patients treated with VORANIGO in the INDIGO trial.

Dosage interruptions1

  • Dosage interruptions of VORANIGO due to an AR occurred in 30% of patients
  • ARs which required dose interruption in ≥5% of patients included ALT increased (14%), COVID-19 (9%), and AST increased (6%)

Dose reductions1

  • Dose reductions of VORANIGO due to an AR occurred in 11% of patients
  • ARs which required dose reduction in ≥5% of patients included ALT increased (8%)

Discontinuations1

  • Permanent discontinuation of VORANIGO due to an AR occurred in 3.6% of patients
  • ARs which resulted in permanent discontinuation of VORANIGO in ≥2% of patients included ALT increased (3%)
Find VORANIGO access and patient support materials

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.

Reference: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2024.

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INDICATION

VORANIGO (40 mg tablets) is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.

Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions included fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure. Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.

DRUG INTERACTIONS

Avoid concomitant use of VORANIGO with strong and moderate CYP1A2 inhibitors. Avoid concomitant use with moderate CYP1A2 inducers and smoking tobacco. Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. If concomitant use of hormonal contraception cannot be avoided, use nonhormonal contraception methods.

LACTATION

Advise women not to breastfeed during VORANIGO treatment and for 2 months after the last dose.

IMPAIRED FERTILITY

VORANIGO may impair fertility of females and males of reproductive potential.

Please see Full Prescribing Information.

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