Voranigo is a new type of isocitrate dehydrogenase-1/2 (IDH1/2) inhibitor, indicated for the treatment of patients aged over 12 years with IDH1/2-mutant grade 2 astrocytoma or oligodendroglioma.

Precautions for Voranigo Administration

Patient Selection and Evaluation

Confirmation by genetic testing: Before administration, the IDH1 or IDH2 mutation status must be confirmed through tumor tissue testing. Currently, there are no FDA-approved companion testing methods, so reliance on laboratory-developed and validated methods is required.

Baseline examination: Includes assessment of liver function (ALT, AST, GGT, total bilirubin, alkaline phosphatase), complete blood count, and renal function. In particular, active liver disease or severe liver injury must be excluded.

Warnings for Administration in Special Populations

Pregnant women: Animal studies have shown that Voranigo has embryotoxicity and may cause fetal malformations. Women of childbearing age must use non-hormonal contraceptive measures during treatment and for 3 months after discontinuing the drug (as the drug may reduce the effectiveness of hormonal contraceptives).

Lactating women: Breastfeeding is prohibited during treatment and for 2 months after the last dose.

Children and elderly patients: The safety of Voranigo in children under 12 years of age has not been established. Elderly patients require individualized evaluation due to limited clinical data.

Risks of Drug Interactions

CYP1A2 inhibitors/inducers: Concomitant use of strong/moderate CYP1A2 inhibitors (e.g., fluvoxamine) or moderate inducers (e.g., phenytoin) should be avoided, as they may significantly affect drug concentrations.

Drugs that are CYP3A substrates: Voranigo may reduce the efficacy of CYP3A substrates (e.g., certain anticoagulants, immunosuppressants), so concomitant use should be avoided.

Monitoring During Voranigo Administration

Liver Function Monitoring

Monitoring frequency: First 2 months of treatment: Test ALT, AST, GGT, and bilirubin every 2 weeks.

Subsequent 2 years: Test once a month.

Increased frequency of monitoring is required if abnormalities occur.

Adverse Reaction Monitoring

Common reactions: Fatigue (33%), headache (28%), COVID-19 infection (28%), muscle pain (24%), diarrhea (21%), nausea (20%), and seizures (16%).

Severe reactions: Hepatotoxicity: Be alert to symptoms of hepatitis or liver failure (jaundice, dark urine, right upper abdominal pain).

Embryotoxicity: Patients of childbearing age need to confirm the effectiveness of contraception regularly.