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. Targeting mutated IDH1 and IDH2 enzymes in astrocytoma or oligodendroglioma decreases the production of 2-hydroxyglutarate and partially restores cellular differentiation.1
IDH, isocitrate dehydrogenase.
Patients appropriate for VORANIGO
Is my patient appropriate for VORANIGO?
VORANIGO is approved for the treatment of adult and pediatric patients who are ≥12 years of age with Grade 2 mIDH1/2 astrocytoma or oligodendroglioma following surgery, including biopsy, sub-total resection, or gross total resection.1
Read more about patients who may be appropriate for treatment with VORANIGO
mIDH1/2, mutant isocitrate dehydrogenase-1 or mutant isocitrate dehydrogenase-2.
Can I use VORANIGO in my patients following gross total resection?
Yes. In the VORANIGO arm of the INDIGO trial, 14% of patients had biopsy, 48% had sub-total resection, and 51% had gross total resection.1 VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Read more about patients who may be appropriate for treatment with VORANIGO
IDH1 or IDH2, isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2.
Can I use VORANIGO in my patients that previously received chemotherapy and/or radiotherapy?
Yes. There is not an exclusion for patients who received prior therapy.1 VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Read more about patients who may be appropriate for treatment with VORANIGO
IDH1 or IDH2, isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2.
When after surgery is it appropriate to start treatment with VORANIGO in my patients?
There is no prespecified waiting period for the use of VORANIGO.1 VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Read more about patients who may be appropriate for treatment with VORANIGO
IDH1 or IDH2, isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2.
Does disease progression or stability affect when I can start treatment with VORANIGO for my patients?
There is no prespecified consideration relative to disease progression or stability for treatment with VORANIGO.1 VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Read more about patients who may be appropriate for treatment with VORANIGO
IDH1 or IDH2, isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2.
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.
Read more about the INDIGO trial design
mIDH1 or mIDH2, mutant isocitrate dehydrogenase-1 or mutant isocitrate dehydrogenase-2.
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; 95% CI, 0.27-0.56; P<0.0001).
Read more about VORANIGO efficacy
HR, hazard ratio.
What was the secondary outcome for VORANIGO in the INDIGO trial?
The secondary outcome for VORANIGO was time to next intervention (TTNI). VORANIGO demonstrated a statistically significant improvement in TTNI when compared to placebo.1
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.
Does VORANIGO impact the fertility of patients?
VORANIGO may impair fertility in females and males of reproductive potential.1
Does VORANIGO affect contraceptives?
VORANIGO can render some hormonal contraceptives ineffective.1
What are the recommendations for using VORANIGO in patients who are pregnant or breastfeeding?
Based on findings from animal studies and its mechanism of action, VORANIGO can cause fetal harm when administered to a pregnant woman.1 Advise pregnant women of the potential risk to the fetus.
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.
Does VORANIGO have a boxed warning?
There is no boxed warning for VORANIGO.1 For more information on the warnings and precautions associated with treatment with VORANIGO, please refer to the Full Prescribing Information.
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.
What monitoring is required for VORANIGO?
Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the initiation 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?
Permanent discontinuation of VORANIGO due to an adverse reaction occurred in 3.6% of patients.1 Adverse reactions which resulted in permanent discontinuation of VORANIGO in ≥2% of patients 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 journeys.
- Support with insurance coverage and reimbursement
- Financial assistance to help patients pay for VORANIGO
- Prescription fulfillment through our network of specialty pharmacies and distributors
Visit ServierONE.com for more information about how ServierONE Patient Support Services can assist your patients
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.
How is VORANIGO supplied and stored?
How VORANIGO is supplied: 10 mg or 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
