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Vοraѕiԁеոib is a an inhibitor of IDH1 and IDH2 enzymes. Mutations in IDH1 or IDH2 can lead to the production of 2-hydroxyglutarate (2-HG) and its accumulation in glioma tissues. This results in changes to DNA hydroxymethylation, gene expression, cellular differentiation, and the tumor microenvironment. IDH1 and IDH2 inhibition 2-HG production and partially restores cellular differentiation.
| T max |
2 hours |
| Time to reach steady state |
14 days |
| Effects with food |
Increased peak concentration and exposure when given with a high-fat or low-fat meal. |
| PPB |
97% |
| Cross blood brain barrier? |
Yes |
Vorasidenib is primarily metabolized by CYP1A2, with minor contributions from other CYP or non-CYP pathways.
| Feces |
85% (55% unchanged) |
| Urine |
5% (0% unchanged) |
| Half-life |
10 days (terminal) |
- Astrocytoma or oligodendroglioma
Refer to the product monograph for a full list and details of approved indications.
Emetogenic Potential:
The following table lists adverse effects that occurred in ≥ 1 % of patients with grade 2 IDH-mutant glioma treated with vorasidenib (with a difference between arms of ≥2% compared with placebo) in the INDIGO Trial. It also includes severe, life-threatening adverse effects.
| ORGAN SITE | SIDE EFFECT* (%) | ONSET** | |||
|---|---|---|---|---|---|
| Gastrointestinal | Abdominal pain (8%) | E | |||
| Anorexia (5%) | E | ||||
| Diarrhea (12%) | E | ||||
| Gastroesophageal reflux disease (4%) | E | ||||
| General | Fatigue (23%) | E | |||
| Hepatobiliary | Hepatotoxicity (1%) | E | |||
| ↑ LFTs (39%) (10% severe) | E | ||||
* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare"
may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal
reports.
** I = immediate (onset in hours to days)
E = early (days to weeks)
D = delayed (weeks to months)
L = late (months to years)
The most common side effects for vorasidenib include ↑ LFTs, fatigue, and diarrhea.
Increased liver enzymes and bilirubin were transient; they improved or resolved with dose modification or treatment discontinuation. Two patients (1.2%) had concurrent ALT or AST > 3x ULN and total bilirubin > 2x ULN. Hepatic failure/necrosis or autoimmune hepatitis has also been observed.
Refer to protocol by which the patient is being treated.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
IDH1 or IDH2 mutation should be confirmed by a validated test prior to starting vorasidenib.
For patients weighing ≥ 40 kg: 40 mg PO Daily
For patients weighing < 40 kg: 20 mg PO Daily
| Dose Level | Vοraѕiԁеոib Dose (mg daily) | |
| Patients weighing ≥ 40 kg | Patients weighing < 40 kg | |
| 0 | 40 | 20 |
| -1 | 20 | 10 |
| -2 | 10 | Discontinue |
| -3 | Discontinue | Not Applicable |
| Toxicity | Grade/Severity | Action | ||
| Hepatotoxicity | ALT or AST | Bilirubin | ||
| >1 to 3 x ULN | and | ≤ 2 x ULN |
Continue at current dose. Monitor LFTs weekly until recovery to < Grade 1. |
|
| >3 to 5 x ULN | and | ≤ 2 x ULN | First Occurrence: Hold*.
|
|
| Recurrence: Hold*, then resume at 1 dose level ↓. | ||||
| >5 to 20 x ULN | and | ≤ 2 x ULN | First Occurrence: Hold*.
|
|
| Recurrence: Discontinue. | ||||
| >3 to 20 x ULN | and | > 2 x ULN |
First Occurrence: Hold*.
|
|
| Recurrence: Discontinue. | ||||
| > 20 x ULN | and | Any | Discontinue. | |
| Other | Grade 3 |
First Occurrence: Hold*.
|
||
| Recurrence: Discontinue. | ||||
| Grade 4 | Discontinue. | |||
* Hold until recovery to ≤ Grade 1 or baseline.
| Hepatic Impairment | Vοraѕiԁеոib Starting Dose |
| Mild (Child-Pugh Class A) | No dosage adjustment recommended. |
| Moderate (Child-Pugh Class B) | No dosage adjustment recommended. |
| Severe (Child-Pugh Class C) | No data available. Assess for benefit vs risk; monitor closely for adverse reactions. |
| Creatinine Clearance (mL/min) | Vοraѕiԁеոib Starting Dose |
| > 40 | No dosage adjustment recommended. |
| ≤ 40 or requiring dialysis | No data available; caution. |
No dose adjustment is recommended for patients ≥ 65 years of age. No overall differences in safety or effectiveness were observed for patients aged 65 years or older.
No clinically significant effects on the pharmacokinetics of vorasidenib were observed based on gender.
No clinically significant effects on the pharmacokinetics of vorasidenib were observed among white, Black or African American, Asian, American Indian/Alaskan Native, Native Hawaiian or Other Pacific Islander, Hispanic, or non-Hispanic patients.
The use of vorasidenib in pediatric patients 12 years and older was extrapolated from population pharmacokinetic data and course of disease in adult patients. Pediatric patients may have a higher risk of adverse drug reactions.
The safety and efficacy of vorasidenib in children under 12 years of age have not been established.
-
Vorasidenib should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
-
Tablets should be swallowed whole with a glass of water, and not split, crushed or chewed.
-
If a dose is missed by less than 6 hours, give the missed dose as soon as possible. If a dose is missed by more than 6 hours, skip the missed dose, and give the next dose at the usual time.
-
If a patient vomits after taking a dose, a replacement dose should not be given. The next dose should be given as usual the following day.
-
Store at room temperature (15°C to 30°C). Once the original bottle is opened, vorasidenib should be used within 60 days.
- Patients who have a hypersensitivity to this drug or any of its components
- Vorasidenib contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medication.
Other Drug Properties:
-
Carcinogenicity:
No information available
-
Genotoxicity:
Not observed in vitro
-
Mutagenicity:
Not observed in vitro
-
Embryotoxicity:
Documented in animals
-
Fetotoxicity:
Documented in animals
-
Pregnancy:
Vorasidenib is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for at least 3 months after the last dose.
Use an additional non-hormonal (e.g., barrier) method of contraception since vorasidenib may reduce the effectiveness of hormonal contraceptives (See Interactions section).
-
Breastfeeding:
Breastfeeding is not recommended during treatment and for at least 2 months after the last dose.
-
Fertility effects:
Documented in animals
Discuss fertility preservation with patients prior to starting treatment.
Vorasidenib is primarily metabolized by CYP1A2 with minor contributions from CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
Pharmacokinetic modeling predicted vorasidenib to have a strong induction effect on sensitive CYP3A substrates, weak-to-moderate induction effect on sensitive CYP2C19 substrates, and weak induction effect on sensitive CYP2B6 substrates.
| AGENT | EFFECT | MECHANISM | MANAGEMENT |
|---|---|---|---|
| Moderate and Strong CYP 1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine) | ↑ vorasidenib exposure (up to 2.5x with moderate inhibitor and 7.2x with strong inhibitor) and/or ↑ risk of toxicity | ↓ metabolism of vorasidenib | Avoid concomitant use. If must co-administer, monitor for increased adverse reactions. |
| Moderate CYP 1A2 inducers (e.g. phenytoin, rifampicin, smoking tobacco) | ↓ vorasidenib exposure by 30-40% and/or ↓ efficacy | ↑ metabolism of vorasidenib | Avoid concomitant use |
| CYP substrates with narrow therapeutic indices (e.g. alfentanil, carbamazepine, cyclosporine, everolimus, fentanyl, ifosfamide, pimozide, quinidine, sirolimus, tacrolimus, tamoxifen) | ↓ concentration and/or efficacy of medications that are CYP2C19 and CYP3A4 substrates | Vorasidenib can induce CYP 2C19 and CYP 3A4 | Avoid concomitant use with CYP2C19 and CYP3A4 substrates with narrow therapeutic indices |
| Hormonal Contraceptives | May ↓ hormonal contraceptives concentration and/or efficacy | ↑ CYP3A4-mediated metabolism of hormonal contraceptives | Concomitant use of a barrier method of contraception is recommended during the treatment and for at least 3 months after the last dose. |
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
| Monitor Type | Monitor Frequency |
|---|---|
Liver function tests |
Baseline, every 2 weeks during the first 2 months, then once monthly for the first 2 years, and as clinically indicated (more frequently in patients with ↑ LFTs). |
CBC |
Baseline and at each visit |
Renal function tests |
Baseline and as clinically indicated |
Clinical toxicity assessment for fatigue and GI effects |
At each visit |
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Exceptional Access Program (EAP Website )
- vorasidenib - For the treatment of Grade 2 astrocytoma or oligodendroglioma in patients with a susceptible IDH1 mutation or IDH2 mutation following surgery, based on criteria
Mellinghoff et al. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601.
Prescribing Information: (VORANIGOTM). Servier Pharmaceuticals LLC. August 2024.
Product Monograph: (VORANIGOTM). Servier Canada Inc. August 27, 2024.
UpToDate Inc. (2025). Vorasidenib [Drug information]. UpToDate Lexidrug. Accessed January 16, 2025.
March 2026 New drug monograph
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
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