Voranigo (vorasidenib) – IDH1/IDH2-Mutant Grade 2 Gliomas

Voranigo Application Scope

Voranigo is a targeted therapy that inhibits mutant IDH1 and IDH2 enzymes to treat certain brain tumors in patients aged 12 and older.

Characteristics

• Ingredients: Vorasidenib

• Properties:

  • IDH1/IDH2 inhibitor

  • Oral, film-coated tablets

  • Classified as a miscellaneous antineoplastic agent

• Packaging Specification:

  • Available in 10 mg and 40 mg tablets

  • Supplied in 30-count bottles

  • Tablets are white to off-white, film-coated, with dosage imprinted in black ink

• Storage:

  • Store at 20°C to 25°C (68°F to 77°F)

  • Keep desiccant canisters in the bottle; do not remove or swallow

  • Use child-resistant cap; keep out of reach of children

• Expiry Date: ​Refer to the packaging for the specific expiration date

• Executive Standard: FDA-approved labeling and prescribing information

• Approval Number: Initial U.S. FDA approval in 2024

• Date of Revision: August 2024

• Manufacturer: Servier Pharmaceuticals LLC, Boston, MA 02210

Guidelines for the Use of Voranigo

• Dosage and Administration:

  • Adults: 40 mg orally once daily

  • Pediatric Patients (12 years and older):

    • ≥40 kg: 40 mg orally once daily

    • <40 kg: 20 mg orally once daily

  • Take with or without food

  • Swallow tablets whole; do not split, crush, or chew

  • Missed Dose: If missed by less than 6 hours, take as soon as possible; if more than 6 hours, skip and take the next dose at the usual time

  • Vomiting: If vomiting occurs after taking a dose, do not take an additional dose; take the next dose at the scheduled time

• Adverse Reactions:

  • Common (≥15%): Fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, seizure

  • Grade 3 or 4 (≥2%) laboratory abnormalities: Increased ALT, AST, GGT, and decreased neutrophils

• Contraindications: None

• Precautions:

  • Hepatotoxicity: Monitor liver function tests prior to initiation, every 2 weeks during the first 2 months, then monthly for the first 2 years, and as clinically indicated

  • Embryo-Fetal Toxicity: Can cause fetal harm; advise patients of potential risk and to use effective nonhormonal contraception

  • Lactation: Advise women not to breastfeed during treatment and for 2 months after the last dose

  • Fertility: May impair fertility in males and females

Voranigo Interactions

• Drug Interactions:

  • Avoid concomitant use with strong and moderate CYP1A2 inhibitors

  • Avoid concomitant use with moderate CYP1A2 inducers and smoking tobacco

  • Avoid concomitant use with CYP3A substrates where minimal concentration changes can reduce efficacy

  • If concomitant use with hormonal contraception cannot be avoided, use nonhormonal contraception methods

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.