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Frequently asked questions (FAQs) about VORANIGO®

About VORANIGO

How do IDH1 and IDH2 mutations impact glioma?

In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations can lead to increased production of 2-HG and impaired cellular differentiation.¹

2-HG, 2-hydroxyglutarate; IDH, isocitrate dehydrogenase.

How does VORANIGO work?

VORANIGO inhibits IDH1 and IDH2 enzymes.¹ Targeting mutated IDH1 and IDH2 enzymes in astrocytoma or oligodendroglioma decreases the production of 2-hydroxyglutarate and partially restores cellular differentiation.

IDH, isocitrate dehydrogenase.

VORANIGO efficacy

What kind of trial was INDIGO?

INDIGO was a randomized, multicenter, double-blind, placebo-controlled trial for 331 patients with Grade 2 mIDH1 or mIDH2 astrocytoma or oligodendroglioma.¹ Patients had prior surgery including biopsy, sub-total resection, or gross total resection.

What was the major efficacy outcome for VORANIGO in the INDIGO trial?

The major efficacy outcome for VORANIGO was progression-free survival (PFS).¹ VORANIGO demonstrated a 61% reduction in the risk of disease progression or death compared to placebo. (HR=0.39^a; 95% CI, 0.27-0.56; P<0.0001^b).

What was the secondary outcome for VORANIGO in the INDIGO trial?

The secondary outcome for VORANIGO was time to next intervention (TTNI).¹ VORANIGO demonstrated a statistically significant improvement in the TTNI when compared to placebo.

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VORANIGO safety

What were the common adverse reactions to VORANIGO in the INDIGO trial?

The safety of VORANIGO was evaluated in 330 patients with Grade 2 mIDH astrocytoma or oligodendroglioma in the INDIGO trial.¹ The most common (≥15%) adverse reactions were fatigue (37%), COVID-19 (33%), musculoskeletal pain (26%), diarrhea (25%), and seizure (16%).

Review full safety information for VORANIGO

mIDH, mutant isocitrate dehydrogenase.

What are the warnings and precautions associated with VORANIGO?

VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis.¹ Patients treated with VORANIGO experienced increased ALT and AST.

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.

Review the full warnings and precautions

ALT, alanine aminotransferase; AST, aspartate aminotransferase.

VORANIGO dosing

How is VORANIGO dosed?

VORANIGO is dosed once daily.¹ The recommended dosage of VORANIGO in adult patients is 40 mg orally once daily. In pediatric patients 12 years and older, the recommended dosage is based on body weight—40 mg orally once daily if weighing ≥40 kg, and 20 mg orally once daily if weighing <40 kg. Continue treatment until disease progression or unacceptable toxicity.

See more about VORANIGO dosing considerations

What monitoring is required for VORANIGO?

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.¹ Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.

Review recommended dose modifications

ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase.

What caused discontinuation of VORANIGO in the INDIGO trial?

The median duration of exposure to VORANIGO was 12.7 months (range, 8.7 to 17.5).¹ Permanent discontinuation occurred in 3.6% of patients who received VORANIGO included ALT increased (3%).

See more about VORANIGO dosing changes

ALT, alanine aminotransferase.

VORANIGO access and resources

Is there support for patients taking VORANIGO?

ServierONE offers helpful resources and tools to help your patients navigate treatment care, costs, and education throughout their journey.

Support with insurance coverage and reimbursement
Financial assistance to help patients pay for VORANIGO
Prescription fulfillment through our network of specialty pharmacies and distributors

To receive more information

Visit
ServierONE.com

Email USPatientServices@servier.com

Call 1-800-813-5905 Monday-Friday, 8 AM to 8 PM ET

Is there financial support for patients taking VORANIGO?

Eligible patients may register online for the Commercial Copay Program at ServierONE-copay.com

How is VORANIGO distributed?

VORANIGO is available through specialty distributors that can ship directly to office- or hospital-based pharmacies, and specialty pharmacies that can ship VORANIGO to your patient’s home or preferred location.

Review available specialty services

How is VORANIGO supplied and stored?

How VORANIGO is supplied

Both the 10 mg tablets and 40 mg tablets are supplied in 30-count bottles.¹

How to store VORANIGO

Store at 20 to 25 °C (68-77 °F) with permitted excursions between 15 and 30 °C (59-86 °F).¹

Find resources to help you and your patients with VORANIGO treatment

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

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.