Voranidenib (Voranigo) is a novel oral targeted therapy, which was first approved for marketing in the United States in 2024. As a dual inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), it provides a new treatment option for patients with specific types of gliomas.
What are the Indications of Voranidenib (Voranigo)?
Primary Indications
The indications of voranidenib are highly targeted, mainly for the treatment of specific types of brain tumors in adult patients and pediatric patients aged 12 years and older.
Tumor Types: Histologically confirmed grade 2 astrocytoma or oligodendroglioma. Both are diffuse gliomas and belong to primary central nervous system tumors.
Gene Mutation: The tumor must harbor susceptible IDH1 or IDH2 gene mutations. IDH mutations are key drivers of such tumors, leading to the abnormal accumulation of the metabolite 2-hydroxyglutarate (2-HG) and promoting tumor growth. Voranidenib exerts its anti-tumor effect by inhibiting the activity of mutant IDH enzymes and reducing 2-HG levels.
Treatment Stage: Indicated for patients after surgery (including biopsy, subtotal resection, or gross total resection).
Prior to the initiation of treatment, the presence of IDH1 or IDH2 mutations in the tumor must be confirmed by reliable testing methods to ensure the accuracy and effectiveness of treatment.
Dosage Forms and Appearance of Voranidenib (Voranigo)
Dosage Forms
10 mg tablets: Each tablet contains 10 mg of voranidenib active ingredient.
40 mg tablets: Each tablet contains 40 mg of voranidenib active ingredient.
Appearance
10 mg tablets: White to off-white, round film-coated tablets. One side is imprinted with the black number "10", and the other side is plain.
40 mg tablets: White to off-white, oval film-coated tablets. One side is imprinted with the black number "40", and the other side is plain.
Ingredients
The core active ingredient of the tablets is voranidenib citrate hemihydrate co-crystal.
In addition to the active ingredient, the tablet core contains a variety of pharmaceutical excipients, such as croscarmellose sodium, magnesium stearate, microcrystalline cellulose, etc., to ensure the molding, stability and dissolution of the tablets.
The tablet coating contains hypromellose, lactose monohydrate and other components. The black imprint on the tablet surface uses pharmaceutical ink containing black iron oxide and other substances.
Storage Method of Voranidenib (Voranigo)
Storage Conditions
Store the bottle at room temperature between 20°C and 25°C (68°F and 77°F).
Short-term excursions between 15°C and 30°C (59°F and 86°F) are permitted during travel.
Avoid exposing the medicine to excessively high or low temperatures, humid environments, and direct sunlight.
Packaging Features
Each bottle of voranidenib tablets is equipped with a desiccant canister inside to absorb moisture and keep the tablets dry. Do not remove or swallow the desiccant canister.
The bottle is equipped with a child-resistant cap, which needs to be pressed down firmly and rotated at the same time to open, effectively preventing accidental ingestion by children.
Other Important Tips
Keep voranidenib and all other medicines out of the reach of children.
Always store the tablets in the original packaging bottle; do not mix tablets of different dosages or batches.
Do not take the tablets if they show discoloration, deliquescence or other abnormal physical characteristics.
