Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
VORA
Palliative
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
First-line monotherapy for patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH-1) mutation or IDH-2 mutation, following surgery
vorasidenib
Exceptional Access Program
(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)
(EAP Website
)
Minimal – No routine prophylaxis; PRN recommended
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
| 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*
|
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| 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
| 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. |
Renal Impairment
| Creatinine Clearance (mL/min) | Vοraѕiԁеոib Starting Dose |
| > 40 | No dosage adjustment recommended. |
| ≤ 40 or requiring dialysis | No data available; caution. |
Dosage in the Elderly
No dose adjustment is recommended for patients ≥ 65 years of age. No overall differences in safety or effectiveness have been observed in patients aged 65 years or older.
Refer to vorasidenib drug monograph(s) for additional details of adverse effects.
|
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
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Refer to vorasidenib drug monograph(s) for additional details.
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Avoid concomitant use of vorasidenib with moderate or strong CYP 1A2 inhibitors due to increased risk of vorasidenib toxicity. If concomitant use is required, monitor for increased adverse reactions.
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Avoid concomitant use of vorasidenib with moderate CYP 1A2 inducers due to the potential for decreased vorasidenib efficacy.
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Avoid concomitant use of vorasidenib with CYP2C19 and CYP3A4 substrates with narrow therapeutic indices.
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Use of an additional barrier method of contraception is recommended during vorasidenib treatment and for at least 3 months after the last dose, since vorasidenib may reduce the effectiveness of hormonal contraceptives.
Refer to vorasidenib drug monograph(s) for additional details.
Administration:
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Vorasidenib should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
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Tablets should be swallowed whole with a glass of water, and not split, crushed or chewed.
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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.
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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.
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Store at room temperature (15°C to 30°C). Once the original bottle is opened, vorasidenib should be used within 60 days.
Contraindications:
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Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/Precautions:
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Vorasidenib tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medication.
Pregnancy/Lactation:
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This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
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Breastfeeding is not recommended during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if applicable).
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Fertility Effects: Documented in animals
Discuss fertility preservation with patients prior to starting treatment.
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.
Recommended Clinical Monitoring
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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).
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CBC; Baseline and at each visit
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Renal function tests; Baseline and as clinically indicated
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Clinical toxicity assessment for fatigue and GI effects; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Reimbursement recommendation: vorasidenib. Canada's Drug Agency, December 2025.
Mellinghoff IK, van den Bent MJ, Blumenthal DT, et al. Vorasidenib in IDH1- or IDH2-mutant low-grade glioma. N Engl J Med 2023 Aug 17;389(7):589-601.
Vorasidenib drug monograph, Ontario Health (Cancer Care Ontario).
March 2026 Added Supplementary Public Funding section (EAP); Updated to a full regimen monograph
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.