Vorasidenib

Class
Targeted therapy
Subclass
Dual mutant isocitrate dehydrogenase 1 / 2 inhibitors
Substance name
Vorasidenib
Brand names
Voranigo®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Astrocytoma in patients with IDH1 or IDH2 mutation • Grade 2, adjuvant setting
•
40 mg PO daily until disease progression or unacceptable toxicity
Taken with or without food.
Oligodendroglioma in patients with IDH1 or IDH2 mutation • Grade 2, adjuvant setting
•
40 mg PO daily until disease progression or unacceptable toxicity
Taken with or without food.
Indications for use
Labeled indications
Adults
•
Treatment of astrocytoma in patients with IDH1 or IDH2 mutation (grade 2, adjuvant setting)
•
Treatment of oligodendroglioma in patients with IDH1 or IDH2 mutation (grade 2, adjuvant setting)
Safety risks
Contraindications
Hypersensitivity to vorasidenib or its components
Tobacco use
•
Avoid tobacco smoking during vorasidenib treatment, as it may decrease vorasidenib plasma concentrations.
Concomitant use of CYP3A substrates
•
Avoid using vorasidenib with CYP3A substrates where a minimal concentration change may reduce therapeutic effect, as vorasidenib may decrease their plasma concentrations.
Concomitant use of potent or moderate CYP1A2 inhibitors
•
Avoid using vorasidenib with strong or moderate CYP1A2 inhibitors, as they may increase vorasidenib plasma concentrations. Monitor for increased adverse reactions and adjust the dosage if concomitant use of moderate CYP1A2 inhibitors cannot be avoided.
Warnings and precautions
Hepatotoxicity
•
Maintain a high level of suspicion, as vorasidenib has been associated with an increased risk of serum transaminase elevations, hepatic failure, hepatic necrosis, and AIH. Evaluate blood chemistry and liver laboratory tests before initiating vorasidenib. Monitor liver laboratory tests 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 monitoring in patients developing transaminase elevations. Interrupt vorasidenib for grade 2-3 reactions. Resume at the same or a reduced dose (20 mg for the first occurrence and 10 mg for the second occurrence) based on severity. Permanently discontinue for grade 4 reactions.
Specific populations
Renal impairment
CrCl > 40 mL/min
•
Use acceptable. No dose adjustment required.
CrCl ≤ 40 mL/min
•
No guidance available. Monitor for adverse reactions.
Renal replacement therapy
Any modality
•
No guidance available. Monitor for adverse reactions.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor liver function tests.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor liver function tests.
Child-Pugh C (severe)
•
No guidance available. Monitor liver function tests. Monitor for adverse reactions.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Evidence of fetal harm in humans. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for at least 3 months after the last dose.
Breastfeeding
Do not use during breastfeeding.
•
Advise females not to breastfeed for 2 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ WBC count, ↑ hemoglobin, ↓ platelet count, ↑ blood neutrophil count, ↑ serum creatinine, ↓ blood lymphocyte count, ↑ serum gamma-glutamyltransferase, ↑ serum potassium, observed seizure, constipation, abdominal pain, diarrhea, fatigue, asthenia, headache, musculoskeletal pain, nausea
Common 1-10%
•
↓ serum calcium, ↑ blood glucose, ↑ serum ALP, ↓ serum phosphate, ↑ serum ALT, ↑ serum AST, loss of appetite
Interactions
Drug(s)
Check Interactions
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