Voranigo 40 mg Film-Coated Tablet, 30 Tablets/Bottle

VORANIGO — 40 mg/1, Film-coated tablet, 1 × 30 bottle in 1 carton

VORANIGO (vorasidenib) is a film-coated tablet for oral use. VORANIGO 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. Supplied as 1 × 30 bottle in 1 carton; NDC 72694-728-40; manufacturer Servier Pharmaceuticals LLC. Rx only. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

• Active ingredient or product type: VORASIDENIB
• Strength/concentration: 40 mg/1
• Dosage form and route: Film-coated tablet, Oral
• Exact package presentation: 1 × 30 bottle in 1 carton
• NDC/item number: 72694-728-40
• Manufacturer/labeler: Servier Pharmaceuticals LLC
• Storage/handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Each carton contains one 30-count bottle of 40 mg tablets with desiccant canister(s) and child-resistant cap (NDC 72694-728-40) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Status: Rx only

Important safety information: Hepatotoxicity : VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.