Vorasidenib is an anticancer medication used to treat certain types of low-grade gliomas (brain tumors) in adults and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma who have a susceptible IDH1 or IDH2 mutation following surgery (including biopsy, subtotal resection, or total resection). It specifically targets tumors with mutations in the IDH1 or IDH2 genes, which are common in these types of gliomas. Vorasidenib works by inhibiting the abnormal IDH1 and IDH2 proteins, which helps to slow tumor growth. 

40 mg PO daily until disease progression or unacceptable toxicity.

To treat adult and pediatric patients 12 years and older with certain types of Astrocytoma or Oligodendroglioma that have not improved with surgery.

Isocitrate dehydrogenase-1 (IDH1) and IDH2 inhibitor.

Inhibits wild-type and mutated IDH1 (e.g., R132H) and IDH2 variants.

Decreases production of 2-hydroxyglutarate (2-HG) and partially restores cellular differentiation based on cell-based and in vivo tumor models.

Oral Administration

May take with or without food.

Administer at about the same time each day.

Swallow the tablet whole with water; do not split, crush, or chew.

Vomited dose

Do not administer a replacement dose.

Return to normal schedule the following day.

Missed dose

Dose missed ≤6 hr of scheduled time.

Administer the dose as soon as possible.

Return to normal schedule the following day.

Dose missed >6 hr of scheduled time

Do not administer the dose.

Return to normal schedule the following day.

The most common (≥15%) adverse reactions included,

Fatigue

Headache

COVID-19

Musculoskeletal pain

Diarrhea

Nausea

Seizure

Grade 3 or 4 (≥2%) laboratory abnormalities included,

Increased ALT (alanine transaminase)

Increased AST (aspartate aminotransferase)

Increased GGT (gamma-glutamyl transferase)

Neutropenia

Strong and moderate CYP1A2 inhibitors

Avoid coadministration.

May increase vorasidenib exposure and risk of adverse effects.

If use with a moderate CYP1A2 inhibitor is unavoidable, monitor for adverse reactions and reduce the vorasidenib dose as necessary.

Moderate CYP1A2 inducers

Avoid coadministration.

May decrease vorasidenib exposure and reduce efficacy.

Store at 20-25ºC (68-77ºF)

Excursions permitted between 15 and 30ºC (59 and 86ºF)

Evaluate blood chemistry and LFTs before initiating.

Test for the presence of IDH1 or IDH2 mutations in tumor specimens.

Avoid smoking tobacco—it may decrease vorasidenib exposure and reduce efficacy.

Monitor liver function tests before initiation, every 2 weeks during the first 2 months, every month for the first 2 years, and as clinically indicated; perform more frequent testing if transaminase elevations occur.

Advise pregnant women and patients of reproductive potential of potential risk to the fetus. Effective contraception is recommended during and after therapy for patients of reproductive potential or who have partners of reproductive potential.

May decrease hormonal contraception exposure and reduce efficacy. If concomitant use is unavoidable, use effective nonhormonal contraception methods during vorasidenib therapy.