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VORANIGO® (vorasidenib) 40 mg tablets: The First and Only mIDH1/2 Inhibitor for Patients With Grade 2 mIDH Glioma

Provide HCPs with up-to-date, evidence-based information on IDH-mutant (mIDH) glioma and VORANIGO® that can help them make informed treatment decisions for patients with mIDH glioma.

Key Takeaways:

  • Review key disease state information and unmet needs in mIDH glioma, including epidemiology, the role of IDH1 and IDH2 mutations in glioma, and the importance of molecular profiling for treatment planning
  • Review the mechanism of action and the clinical efficacy and safety profile that supports the use of VORANIGO in patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation

This event has expired. No longer available for credits.

Time and location

Wednesday, October 16, 2024

12:15 PM - 1:00 PM Eastern Time (ET)

Virtual

Faculty
Rimas V Lukas, MD

Associate Professor of Neurology (Neuro-oncology)
Feinberg School of Medicine
Northwestern University
Chicago, Illinois

Sponsored By

Servier Pharmaceuticals

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Additional Information

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.

 

Prescribing Information

US-03308_9/24