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Is VORANIGO® appropriate for your patients?

Learn what types of patients with mIDH glioma may be appropriate for VORANIGO after surgery1

MEET STACIE

Stacie has Grade 2 astrocytoma and received a sub-total resection a few months ago

Patient Information

  • Age: 39
  • Occupation: Full-time worker at a childcare center and part-time student
  • Support System includes: Samantha (sister) and Candice (best friend)
  • Hobbies: Writing and running

Clinical Summary

  • Diagnosis: Grade 2 astrocytoma
  • Time after surgery: 2 months post-resection
  • Mutation profile: IDH1 R132H mutation and CDKN2A/B intact

Clinical History

  • Presentation: Seizures, worsening headaches, experienced episodes of numbness/tingling in left side of face lasting for minutes, leading to brain imaging
  • Pre-surgical tumor size: 3.6 x 2.7 cm
  • Surgical result: Sub-total resection
  • Post-surgical tumor size: 2.5 x 2.0 cm
  • Relevant labs: Normal BMP, LFTs, and CBC
  • Relevant MRI scans: 2-month MRI shows 2.5 cm residual tumor, mild post-surgical edema, no enhancement, and no signs of progression

Hypothetical patient.

Explore data from the INDIGO trial to see how VORANIGO can help patients like Stacie

MEET STEVEN

Steven has Grade 2 oligodendroglioma and had surgery multiple years ago

Patient Information

  • Age: 61
  • Occupation: Farmer
  • Support System includes: Sharon (wife), Lily (daughter), and Sam (son)
  • Hobbies: Fishing and beekeeping

Clinical Summary

  • Diagnosis: Grade 2 oligodendroglioma
  • Time after surgery: 4.5 years post-resection with stable residual disease
  • Mutation profile: IDH1 R132H mutation and 1p/19q-codeletion; CDKN2A/B intact

Clinical History

  • Presentation: Seizures
  • Pre-surgical tumor size: ~5 cm diameter
  • Surgical result: Sub-total resection
  • Post-surgical tumor size: 3 cm diameter
  • Relevant labs: Normal BMP and CBC
  • Relevant MRI scans: Most recent MRI imaging continues to show stable tumor size

Hypothetical patient.

Explore data from the INDIGO trial to see how VORANIGO can help patients like Steven

MEET GARY

Gary has Grade 2 astrocytoma and received a gross total resection

Patient Information

  • Age: 36
  • Occupation: Retail purchasing and stocking
  • Support System includes: Alicia (wife) and Garrett (brother)
  • Hobbies: Sports and outdoor activities

Clinical Summary

  • Diagnosis: Grade 2 astrocytoma
  • Time after surgery: 7 months post-resection
  • Mutation profile: IDH1 R132H mutation and CDKN2A/B intact

Clinical History

  • Presentation: 6 months of increasing headaches and blurry vision
  • Pre-surgical tumor size: 3 x 5 cm
  • Surgical result: Gross total resection
  • Post-surgical tumor size: No residual disease
  • Relevant labs: Normal LFTs; Creatinine 1.3 mg/dL
  • Relevant MRI scans: 6-month post-op MRI showed no evidence of recurrent disease

Hypothetical patient.

Explore data from the INDIGO trial to see how VORANIGO can help patients like Gary

Help your patients with Grade 2 mIDH glioma halt disease progression with VORANIGO1
VORANIGO patient profiles are also available as a downloadable reference for your convenience

BMP, basic metabolic panel; CBC, complete blood count; LFTs, liver function tests; mIDH1/2, mutant isocitrate dehydrogenase-1 or mutant isocitrate dehydrogenase-2; MRI, magnetic resonance imaging.

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

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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.

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