VORASIDENIB

Other

Brand names: VORANIGO

Oral

Mechanism of Action

12.1 Mechanism of Action Vorasidenib is a small molecule inhibitor that targets isocitrate dehydrogenase-1 and 2 (IDH1 and IDH2) enzymes. In vitro, vorasidenib inhibited the IDH1 wild type and mutant variants, including R132H and the IDH2 wild type and mutant variants. In cell-based and in vivo tumor models expressing IDH1 or IDH2 mutated proteins, vorasidenib decreased production of 2-hydroxyglutarate (2-HG) and partially restored cellular differentiation.

Indications

as detected by an FDA-approved test

following surgery including biopsy

sub-total resection

or gross total resection [see Dosage and Administration (2.1)

as detected by an FDA-approved test

following surgery including biopsy

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS 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
Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception
Advise pregnant women and females of reproductive potential of the potential risk to a fetus

Known Side Effects

5 documented side effects by frequency

Fatigue

1-10%

Headache

1-10%

Nausea

1-10%

Diarrhea

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral