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

The safety of VORANIGO® was evaluated in 330 patients in the INDIGO trial¹

Most common adverse reactions (ARs) of 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%)

The most common and severe 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%)

See adjustments to dosing and management due to hepatic changes

ARs and select laboratory abnormalities

ARs (≥5%) in patients with Grade 2 IDH1/2 mutant glioma who received VORANIGO compared with placebo in the INDIGO trial.¹

	VORANIGO (40 mg daily)(n=167)		Placebo(n=163)
Adverse reaction^a	All Grades(%)	Grades 3 or 4(%)	All Grades(%)	Grades 3 or 4(%)
General disorders
Fatigue^b	37	0.6	36	1.2
Infections and infestations
COVID-19	33	0	29	0
Nervous system disorders
Seizure^c	16	4.2	15	3.7
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^d	26	0	25	1.8
Gastrointestinal disorders
Diarrhea^e	25	0.6	17	0.6
Constipation	13	0	12	0
Abdominal pain^f	13	0	12	0
Decreased appetite	9	0	3.7	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.

Select laboratory abnormalities (≥5%) that worsened from baseline in patients with Grade 2 IDH1/2 mutant glioma who received VORANIGO in the INDIGO trial.¹

	VORANIGO (40 mg daily)(n=167)		Placebo(n=163)
Parameter	All Grades^g (%^h)	Grades^g 3 or 4 (%^h)	All Grades^g (%^h)	Grades^g 3 or 4 (%^h)
Chemistry
Increased ALT	59	10	25	0
Increased AST	46	4.8	20	0
Increased creatinine	11	0.6	7	0
Decreased calcium	10	0	7	0
Increased glucoseⁱ	10	0	4.3	0
Increased GGT	38	3	10	1.8
Decreased phosphate^j	8	0.6	4.9	0
Increased potassium	23	0.6	20	0
Increased ALP	10	1.2	7	0.6
Hematology
Increased hemoglobin	13	0	3.1	0
Decreased lymphocytes	11	1.8	8	0.6
Decreased leukocytes	13	0.6	12	0.6
Decreased neutrophils	14	2.4	12	1.8
Decreased platelets	12	0	4.3	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.

Read about dosing guidelines for treatment with VORANIGO

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; ULN, upper limit of normal.

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.

The safety of VORANIGO® was evaluated in 330 patients in the INDIGO trial1

Most common adverse reactions (ARs) of VORANIGO in INDIGO

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

The most common and severe ARs in patients who received VORANIGO1:

ARs and select laboratory abnormalities

ARs (≥5%) in patients with Grade 2 IDH1/2 mutant glioma who received VORANIGO compared with placebo in the INDIGO trial.1

Select laboratory abnormalities (≥5%) that worsened from baseline in patients with Grade 2 IDH1/2 mutant glioma who received VORANIGO in the INDIGO trial.1

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

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