Non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation

Active Ingredient: Vorasidenib

Indication for Vorasidenib

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments:

40 mg once daily for patients weighing at least 40 kg

For:

Dosage regimens

In case that patient weight is ≥ 40 kg

Oral, 40 milligrams vorasidenib, once daily.

Detailed description

The recommended dose of vorasidenib in adults and adolescents 12 years of age and older is 40 mg once daily for patients weighing at least 40 kg. No dose recommendation can be made in patients weighing less than 40 kg because of the lack of clinical data in this population.

Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.

Missed or delayed doses

If a dose is missed or not taken at the usual time, it should be taken as soon as possible within 6 hours after the missed dose. The next dose should be taken at the regularly scheduled time.

If a dose is missed by more than 6 hours, it should be skipped and the next dose should be taken at the regularly scheduled time.

If a dose is vomited, replacement dose should not be taken. The dose should be taken as usual the following day.

Precautions to be taken prior to administration and monitoring

Complete blood counts and blood chemistries, including liver enzymes, should be assessed prior to starting treatment, every 2 weeks during the first 2 months and then once monthly for the first 2 years of treatment, and as clinically indicated thereafter. Certain patients may require more frequent and ongoing monitoring.

Dose modifications for adverse reactions

Dose interruption or dose reduction may be required based on individual safety and tolerability. The recommended dose reduction levels are provided in the following table.

Recommended dose reduction levels:

Dose levelDose and schedule
Starting dose40 mg once daily
First dose reduction20 mg once daily
Second dose reduction10 mg once daily

Dosage considerations

Vorasidenib should be taken once daily at about the same time each day. Patients should not eat food at least 2 hours before and 1 hour after taking vorasidenib.

Active ingredient

Vorasidenib

Vorasidenib is an inhibitor that targets the mutant IDH1 and IDH2 enzymes. In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations lead to overproduction of the oncogenic metabolite 2-hydroxyglutarate (2-HG), resulting in impaired cellular differentiation contributing to oncogenesis. Inhibition of the IDH1- and IDH2-mutated proteins by vorasidenib inhibits the abnormal production of 2-HG leading to differentiation of malignant cells and a reduction in their proliferation.

Read more about Vorasidenib

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