Lucius LuciVora Vorasidenib 40mg

Product Information

• Product name: LuciVora Vorasidenib 40mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Vorasidenib
• Current strength: 40mg
• SKU: LU-ITEM-128
• Site category: cell tumor, other cancer

Product Summary

LuciVora Vorasidenib 40mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Vorasidenib is the active ingredient used for this product page. Public prescribing information for Vorasidenib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Vorasidenib is a small molecule inhibitor that targets isocitrate dehydrogenase-1 and 2 (IDH1 and IDH2) enzymes.

Reference Indications

Vorasidenib 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, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection . Vorasidenib is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection.

Reference Dosage and Administration

Recommended dosage in adults: 40 mg orally once daily Recommended dosage in pediatric patients 12 years of age and older based on body weight: ≥40 kg : 40 mg orally once daily <40 kg : 20 mg orally once daily Take with or without food.

With this 40mg product, that corresponds to 1 x 40mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Hepatotoxicity : Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose or discontinue Vorasidenib based on severity. ( 2.3 , 5.1 ) Embryo-Fetal Toxicity : Vorasidenib can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception. ( 5.2 , 8.1 , 8.3 ) 5.1 Hepatotoxicity Vorasidenib can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Grade 3 or 4 increased ALT or AST occurred in 9% and 4.8% of patients respectively. Among these patients, 4.1% (10/244) had concurrent Grade 3 to 4 ALT or AST elevations.

Common Adverse Reactions and Monitoring

Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased. Among the 244 patients who received Vorasidenib, 78% were exposed for 6 months or longer and 44% were exposed for greater than one year. INDIGO The safety of Vorasidenib was evaluated in 330 patients with Grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation who received at least one dose of either Vorasidenib 40 mg daily (N=167) or placebo (N=163) in the INDIGO trial . Patients received Vorasidenib 40 mg orally once daily or placebo orally once daily until disease progression or unacceptable toxicity.

Drug Interactions and Special Populations

CYP1A2 Inhibitors : Avoid concomitant use of strong and moderate CYP1A2 inhibitors. CYP1A2 Inducers : Avoid concomitant use of moderate CYP1A2 inducers and smoking tobacco. Certain CYP3A Substrates : Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. Hormonal Contraception : If concomitant use cannot be avoided, use with nonhormonal contraception methods. Prevention or Management Avoid concomitant use of Vorasidenib with strong and moderate CYP1A2 inhibitors. Moderate CYP1A2 Inducers Clinical Impact Concomitant use of Vorasidenib with moderate CYP1A2 inducers and smoking tobacco may decrease vorasidenib plasma concentrations , which may reduce the anti-tumor activity of Vorasidenib.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: VORANIGO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.