Vorasidenib

Vorasidenib tablets treat brain cancers called astrocytoma or oligodendroglioma with a specific mutation called IDH1 or IDH2. It is a once-daily tablet used to help manage IDH-mutant astrocytoma or oligodendroglioma cancer after surgery. Vorasidenib brand name is Voranigo by Servier Pharmaceuticals.

Astrocytoma and oligodendroglioma are a type of glioma, a tumor that develops from cells within the central nervous system (CNS). Mutations in the IDH1 and IDH2 genes cause abnormal cell growth, potentially leading to tumors. Vorasidenib works by blocking these mutant enzymes, reducing tumor activity.

Vorasidenib drug class is a DH1 and IDH2 inhibitor (isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitors). Vorasidenib mechanism of action involves blocking IDH1 and IDH2 enzymes, decreasing 2-hydroxyglutarate (2-HG) production, and partially restoring normal cellular differentiation.

Voranigo FDA-approval is for the treatment of Grade 2 astrocytoma or oligodendroglioma containing susceptible IDH1 or IDH2 mutations for patients 12 years and older. It is used after surgery, including biopsy, sub-total resection, or gross total resection. Voranigo FDA approval was granted on August 6, 2024, to Servier Pharmaceuticals, after positive results from the Vorasidenib clinical trial Phase 3 INDIGO.

The Vorasidenib Phase 3 INDIGO clinical trial found that:

• Vorasidenib patients had a significantly extended progression-free survival of 27.7 months (median) compared to 11.1 months in the placebo group.
• Tumor volume decreased by 2.5% every 6 months in the Vorasidenib group, while the placebo group had a 13.9% mean increase over the same period.
• Disease progression at 14 months was 28% vorasidenib group and 54% for the placebo group compared

• Once daily at the same time each day.
• Swallow whole with water—take with or without food.
• Do not split, crush, or chew tablets.

Missed Dose:

• If missed by less than 6 hours, take it as soon as possible.
• If missed by more than 6 hours, skip it and take the next dose at the usual time.

Vomiting:

• If vomiting occurs after taking Voranigo, do not take another dose—wait until the next scheduled dose.

Tell Your Doctor If You:

• Have liver or kidney problems
• Have kidney problems or are on dialysis
• Smoke tobacco

Pregnancy

Vorasidenib can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant.

Females who are able to become pregnant

• Your healthcare provider will do a pregnancy test before you start treatment with Voranigo.
• You should use effective nonhormonal birth control during treatment with these tablets and for 3 months after the last dose.
• Voranigo may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with this medicine.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with this medicine.

Males with female partners who can become pregnant

• You should use effective birth control during treatment with vorasidenib and for 3 months after the last dose.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with this medicine.

Common Vorasidenib Side Effects:

• Tiredness (37%)
• COVID-19 (33%)
• Muscle or joint pain (26%)
• Diarrhea (25%)
• Seizures (16%)
• Constipation (13%)
• Abdominal pain (13%)
• Decreased appetite (9%)
• Nausea
• Changes in lab tests (Grade 3 or 4): Increased ALT, AST, GGT, and decreased neutrophils.

These common side effect occurred in 5% or more of patients who received Vorasidenib 40mg day in the Adverse Reactions (≥5%) in Patients Phase 3 INDIGO clinical trial INDIGO Trial

Serious Side Effects:

Liver Problems: Vorasidenib may cause serious changes in liver function. Regular blood tests are necessary. Contact your doctor if you experience:

• Yellowing of skin or eyes (jaundice)
• Dark, tea-colored urine
• Loss of appetite
• Pain in the upper right stomach area
• Extreme fatigue or weakness

Your doctor may adjust, pause, or stop treatment based on side effects.

Fertility Concerns: Voranigo may affect fertility in males and females. Talk to your doctor if this is a concern.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Adults:

• 40 mg orally once daily until disease progression or unacceptable toxicity.

Pediatric Patients (12+ Years):

• ≥40 kg: 40 mg orally once daily
• <40 kg: 20 mg orally once daily
• Continue until disease progression or unacceptable toxicity.

Vorasidenib may interact with prescription and over-the-counter drugs, vitamins, and herbal supplements. Not all possible interactions are listed here.

• Tell your healthcare provider about all medications you take.
• Keep a medication list to show your doctor when starting a new drug.

Review the Vorasidenib Package Insert for more detailed information about this medicine. The Vorasidenib Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Prescribing Information (PI) or FDA label.

Voranigo (Vorasidenib) J Code is J8999 J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need the Voranigo J code when filling out forms for your treatment.

• Store at room temperature (68°F–77°F / 20°C–25°C).
• Keep the desiccant canisters in the bottle—do not swallow them.
• Use the child-resistant cap and keep out of reach of children.

Active Ingredient:

• Vorasidenib

Inactive Ingredients:

• Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, sodium lauryl sulfate

Tablet Coating:

• Hypromellose, lactose monohydrate, macrogol, titanium dioxide

Black Printing Ink:

• Black iron oxide, hypromellose, propylene glycol

• Voranigo manufacturer Servier Pharmaceuticals LLC, Boston, MA 02210