This site is intended for U.S. healthcare professionals.

INDIGO trial: Safety of VORANIGO versus placebo in 330 patients with mIDH glioma¹

The median duration of exposure to VORANIGO in the INDIGO trial 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%)

The most common and severe adverse reactions (ARs) in patients who received VORANIGO¹:

The most common (≥15%) ARs were fatigue (37%), COVID-19 (33%), musculoskeletal pain (26%), diarrhea (25%), and seizure (16%)
Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased (10%), AST increased (4.8%), GGT increased (3%), and neutrophil decreased (2.4%)
Serious ARs occurred in 7% of patients who received VORANIGO. The most common serious ARs occurring in ≥2% of patients who received VORANIGO includes seizure (3%)

The INDIGO trial assessed ARs of VORANIGO compared with placebo¹

ARs reported in ≥5% of patients in the INDIGO trial¹

VORANIGO 40 mg daily (n=167)

Placebo (n=163)

Adverse reaction^a	All Grades (%)	Grades 3 or 4 (%)
General disorders
Fatigue^b	37 37% 36 36%	0.6 0.6% 1.2 1.2%
Infections and infestations
COVID-19	33 33% 29 29%	0 0% 0 0%
Nervous system disorders
Seizure^c	16 16% 15 15%	4.2 4.2% 3.7 3.7%
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^d	26 26% 25 25%	0 0% 1.8 1.8%
Gastrointestinal disorders
Diarrhea^e	25 25% 17 17%	0.6 0.6% 0.6 0.6%
Constipation	13 13% 12 12%	0 0% 0 0%
Abdominal pain^f	13 13% 12 12%	0 0% 0 0%
Decreased appetite	9 9% 3.7 3.7%	0 0% 0 0%

^aARs are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

^bGrouped term includes asthenia.

^cGrouped term includes partial seizures, generalized tonic-clonic seizure, epilepsy, clonic convulsion, and simple partial seizures.

^dGrouped term includes arthralgia, back pain, non-cardiac chest pain, pain in extremity, myalgia, neck pain, musculoskeletal chest pain, arthritis, and musculoskeletal stiffness.

^eGrouped term includes feces soft and frequent bowel movements.

^fGrouped term includes abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and epigastric discomfort.

Treatment adjustments may be needed due to ARs

Learn more

Select lab abnormalities for VORANIGO compared with placebo

Select laboratory abnormalities worsening from baseline occurring in ≥5% of patients¹

VORANIGO 40 mg daily (n=167)

Placebo (n=163)

Parameter	All Grades^g (%^h)	Grades^g 3 or 4 (%^h)
Chemistry
Increased ALT	59 59% 25 25%	10 10% 0 0%
Increased AST	46 46% 20 20%	4.8 4.8% 0 0%
Increased creatinine	11 11% 7 7%	0 0% 0 0%
Decreased calcium	10 10% 7 7%	0 0% 0 0%
Increased glucoseⁱ	10 10% 4.3 4.3%	0 0% 0 0%
Increased GGT	38 38% 10 10%	3 3% 1.8 1.8%
Decreased phosphate^j	8 8% 4.9 4.9%	0.6 0.6% 0 0%
Increased potassium	23 23% 20 20%	0.6 0.6% 0 0%
Increased ALP	10 10% 7 7%	1.2 1.2% 0.6 0.6%
Hematology
Increased hemoglobin	13 13% 3.1 3.1%	0 0% 0 0%
Decreased lymphocytes	11 11% 8 8%	1.8 1.8% 0.6 0.6%
Decreased leukocytes	13 13% 12 12%	0.6 0.6% 0.6 0.6%
Decreased neutrophils	14 14% 12 12%	2.4 2.4% 1.8 1.8%
Decreased platelets	12 12% 4.3 4.3%	0 0% 0 0%

^gBased on NCI CTCAE v5.0.

^hThe denominator used to calculate percentages is N, the number of subjects in the Safety Analysis Set within each treatment group.

ⁱIncludes AR term hyperglycemia.

^jIncludes AR terms hypophosphatemia and blood phosphorus decreased.

Treatment modifications may be needed due to laboratory abnormalities

Learn more

Learn more about dosing and administration of once-daily VORANIGO

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; mIDH, mutant isocitrate dehydrogenase.

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.

INDIGO trial: Safety of VORANIGO versus placebo in 330 patients with mIDH glioma1

The median duration of exposure to VORANIGO in the INDIGO trial was 12.7 months (range: 1 to 30 months)1

The most common and severe adverse reactions (ARs) in patients who received VORANIGO1:

The INDIGO trial assessed ARs of VORANIGO compared with placebo1

ARs reported in ≥5% of patients in the INDIGO trial1

Select lab abnormalities for VORANIGO compared with placebo

Select laboratory abnormalities worsening from baseline occurring in ≥5% of patients1

The information on this website is for U.S. healthcare professionals only.

You are now leaving the VORANIGO® (vorasidenib) website for U.S. healthcare professionals.

INDICATION

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

LACTATION

IMPAIRED FERTILITY

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INDIGO trial: Safety of VORANIGO versus placebo in 330 patients with mIDH glioma¹

The median duration of exposure to VORANIGO in the INDIGO trial was 12.7 months (range: 1 to 30 months)¹

The most common and severe adverse reactions (ARs) in patients who received VORANIGO¹:

The INDIGO trial assessed ARs of VORANIGO compared with placebo¹

ARs reported in ≥5% of patients in the INDIGO trial¹

Select laboratory abnormalities worsening from baseline occurring in ≥5% of patients¹

You are now leaving the VORANIGO^® (vorasidenib) website for U.S. healthcare professionals.