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BELZ
(associated with von Hippel-Lindau (VHL) disease)
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.
For patients with von Hippel-Lindau (VHL) disease, who require treatment for associated non-metastatic renal cell carcinoma (RCC) or non-metastatic pancreatic neuroendocrine tumour (pNET), not requiring immediate surgery.
(Refer to full EAP criteria.)
belzutifan
Exceptional Access Program
(Belzutifan – For the treatment of adult patients with von Hippel-Lindau (VHL) disease, based on criteria)
(EAP Website)
Low – 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 | Belzutifan (mg daily) |
| 0 | 120 |
| -1 | 80 |
| -2 | 40 |
| -3 | Discontinue |
| Toxicity | Severity/Grade | Action |
| Anemia | Grade 3 or transfusion indicated |
Hold* Resume at same dose or at 1 dose level ↓ OR consider discontinuing depending on severity and/or persistence of toxicity. |
| Grade 4 |
Hold* Resume at 1 dose level ↓ OR discontinue. Discontinue if recurrence of Grade 4. |
|
| Hypoxia | Grade 2 |
Consider continuing or holding until resolved. If held, consider resuming at reduced dose depending on severity and/or persistence of toxicity.
|
| Grade 3 |
Hold until resolved. Resume at 1 dose level ↓ OR discontinue depending on severity and/or persistence of toxicity.
|
|
| Grade 4 or recurrent symptomatic hypoxia |
Discontinue. |
|
| Other Adverse Reactions | Grade 3 |
Hold* Consider resuming at 1 dose level ↓. Discontinue if recurrence of Grade 3. |
| Grade 4 | Discontinue. |
*Do not restart until toxicity resolved to ≤ Grade 2.
Hepatic Impairment
| Bilirubin | AST | Belzutifan Dose | |
| ≤ ULN | and | > ULN | No dose adjustment recommended |
| >1 to 1.5 x ULN | and | Any | |
| > 1.5 x ULN | and | Any | No data |
Renal Impairment
| Creatinine Clearance* | Belzutifan Dose |
| ≥ 30 | No dose adjustment recommended |
| < 30 | No data |
*Reported as eGFR in mL/min/1.73m2
Dosage in the Elderly
No dose adjustment is needed in patients ≥ 65 years of age. No overall difference in safety or efficacy was reported between patients ≥ 65 years of age and younger patients. Differences in belzutifan tolerability profile were observed in patients ≥ 65 years of age compared to younger patients
Refer to belzutifan drug monograph(s) for additional details of adverse effects.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to belzutifan drug monograph(s) for additional details.
-
Avoid concomitant use with sensitive CYP3A4 substrates for which minimal concentration ↓ may lead to substrates' therapeutic failures. If must co-administer, ↑ dosage of CYP3A4 substrate as per substrate's product monograph.
-
Avoid concomitant use with hormonal contraceptives. Advise patients of the need for highly effective non-hormonal contraception methods, since belzutifan may reduce the effectiveness of hormonal contraceptives.
-
Use caution and monitor for increased adverse reactions when co-administering with UGT2B17 or CYP2C19 inhibitors, due to increased belzutifan exposure and/or risk of belzutifan toxicity.
Refer to belzutifan drug monograph(s) for additional details.
Administration
-
Administer belzutifan with or without food.
-
Tablets should be swallowed whole. Do not chew, crush, or split the tablets.
-
If a dose is missed, it can be given as soon as possible on the same day. Then administer the scheduled daily dose on the next day. Do not give extra tablets to make up for the missed dose.
-
If a patient vomits after taking belzutifan, do not give another dose. The next dose should be given at the scheduled time on the following day.
-
Store at room temperature (15°C to 30°C).
Contraindications/Precautions
- Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/ Precautions:
-
Caution with driving or using machinery as dizziness may occur with treatment.
Pregnancy/ Lactation:
-
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.
-
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 available).
-
Fertility Effects: Probable
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
- CBC; Baseline, at each visit, and as clinically indicated
- Oxygen saturation; Baseline and at each visit, and as clinically indicated (May consider monitoring at home when starting treatment and as clinically indicated)
- Liver function tests; Baseline, at each visit, and as clinically indicated
- Renal function tests; Baseline, at each visit, and as clinically indicated
- Clinical toxicity assessment for fatigue, musculoskeletal pain, edema, ophthalmic or GI effects, dyspnea, bleeding; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Belzutifan drug monograph. Ontario Health (Cancer Care Ontario).
CADTH Reimbursement Recommendation: Belzutifan (Welireg). Canadian Journal of Health Technologies. September 2023
Jonasch E, Donskov F, Iliopoulos O, et al. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 25;385(22):2036-2046. doi: 10.1056/NEJMoa2103425.
June 2025 Expanded into 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.
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