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Access for VORANIGO®

ServierONE Patient Support Services

ServierONE offers helpful resources and tools to help your patients navigate treatment care, costs, and education throughout their journeys.

ServierONE Patient Support Services include:

Support with insurance coverage and reimbursement

Financial assistance to help patients pay for their medication

Prescription fulfillment through our network of specialty pharmacies and distributors

Tools and resources to navigate the world of insurance

To receive more information

Visit ServierONE.com

Email USPatientServices@servier.com

Call 1-800-813-5905 Monday-Friday, 8 AM to 8 PM ET

Register your patients online for the Commercial Copay Program at ServierONE-copay.com

VORANIGO product information

National Drug Code (NDC)¹

Dosage strength	40 mg/tablet	10 mg/tablet
NDCs	10-digit code: 72694-728-40 11-digit code: 72694-0728-40	10-digit code: 72694-879-10 11-digit code: 72694-0879-10
Description	White to off-white, oblong, film-coated tablet imprinted with “40” in black ink on one side and plain on the other side.	White to off-white, round, film-coated tablet imprinted with “10” in black ink on one side and plain on the other side.

Dosage strength	40 mg/tablet
NDCs	10-digit code: 72694-728-40 11-digit code: 72694-0728-40
Description	White to off-white, oblong, film-coated tablet imprinted with “40” in black ink on one side and plain on the other side.

Dosage strength	10 mg/tablet
NDCs	10-digit code: 72694-879-10 11-digit code: 72694-0879-10
Description	White to off-white, round, film-coated tablet imprinted with “10” in black ink on one side and plain on the other side.

The red zero converts the 10-digit NDC to the 11-digit NDC. Some payers may require each NDC to be listed on the claim. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

How VORANIGO is supplied

10 mg or 40 mg tablets supplied in 30-count bottles.¹

How to store VORANIGO

Store at 20 to 25 °C (68-77 °F) with permitted excursions between 15 to 30 °C (59-86 °F).¹

Distribution network for VORANIGO

Specialty distributors

VORANIGO is available through specialty distributors for shipment directly to office- or hospital-based pharmacies.

McKesson Specialty Health

Multispecialty

Oncology

Cardinal Health Specialty Pharmaceutical Distribution (US)

Physician Office

Hospitals/All Other

Cardinal Health (Puerto Rico)

ASD Healthcare

Oncology Supply

Network specialty pharmacies

VORANIGO ships directly from the specialty pharmacy to your patient's home or preferred location.

Biologics by McKesson

Onco360

Resources for VORANIGO access

VORANIGO Patient Access Support Kit

Download the VORANIGO Patient Access Support Kit for tools and templates to help navigate insurance and patient access.

Letter of Medical Necessity
Formulary Exception Request Guide
Prior Authorization Request Guide
Letter of Appeal Guide

Codes Applicable to VORANIGO
Support for Your Patients
Peer Reviewed Article References

Download

VORANIGO Distribution Fact Sheet

Download the VORANIGO Distribution Fact Sheet for a look at our network of specialty distributors and specialty pharmacies.

Download

Review frequently asked questions about VORANIGO

Reference: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2024.

INDICATION

VORANIGO (40 mg tablets) 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 following surgery including biopsy, sub-total resection, or gross total resection.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.

Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions included fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure. Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.

DRUG INTERACTIONS

Avoid concomitant use of VORANIGO with strong and moderate CYP1A2 inhibitors. Avoid concomitant use with moderate CYP1A2 inducers and smoking tobacco. Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. If concomitant use of hormonal contraception cannot be avoided, use nonhormonal contraception methods.

LACTATION

Advise women not to breastfeed during VORANIGO treatment and for 2 months after the last dose.

IMPAIRED FERTILITY

VORANIGO may impair fertility of females and males of reproductive potential.

Please see Full Prescribing Information.