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.
ZOLB(MNT)
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.
Maintenance treatment of CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, in patients who received platinum-fluoropyrimidine chemotherapy and zolbetuximab
(Refer to the NDFP eligibility form for detailed funding criteria.)
zolbetuximab
New Drug Funding Program
(Zolbetuximab - First-line Treatment of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma)
(NDFP Website
)
As single agent maintenance:
| zolbetuximab | 600 mg /m² | IV | Day 1; every 3 weeks |
|
OR |
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| zolbetuximab | 400 mg /m² | IV | Day 1; every 2 weeks |
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Dose reductions are not recommended for zolbetuximab.
| Toxicity | Severity/ Grade | Action | Next Infusion |
| Nausea | Grade 2 or 3 |
Hold infusion until Grade ≤1, then resume at a reduced rate*. |
Administer per infusion rates in Administration Guidelines section. |
| Vomiting | Grade 2 or 3 |
Hold infusion until Grade ≤1, then resume at a reduced rate*. |
Administer per infusion rates in Administration Guidelines section. |
| Grade 4 | Discontinue. | Not applicable |
*Reduced infusion rate should be determined based on patient tolerability, toxicity severity, and previously tolerated rate.
Management of Infusion-related reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
|
Grade |
Management |
Re-challenge |
|
2 |
Restart
|
|
|
3 or 4 |
|
|
*Reduced infusion rate should be determined based on patient tolerability, toxicity severity, and previously tolerated rate.
Hepatic Impairment
| Total bilirubin | AST | Zolbetuximab Dose | |
| ≤ ULN | and | > ULN | No dose adjustments recommended. |
| >1 to 1.5 x ULN | and | Any | |
| >1.5 to 3 x ULN | and | Any | Limited data available. |
| >3 to 10 x ULN | and | Any | Not studied. |
Renal Impairment
| Creatinine Clearance (mL/min) | Zolbetuximab Dose |
| ≥30 | No dose adjustment recommended. |
| <30 | Limited data available. |
Dosage in the Elderly
No dose adjustments is required in patients ≥65 years old. There were no overall differences in safety or efficacy of zolbetuximab when compared to younger patients
Refer to zolbetuximab drug monograph(s) for additional details of adverse effects
The following adverse effects were mostly observed in a clinical trial that administered zolbetuximab in combination with mFOLFOX6.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to zolbetuximab drug monograph(s) for additional details
Zolbetuximab is not a cytokine modulator and is not expected to have an effect on cytochrome P450 or drug transporters. No pharmacokinetic drug interaction studies have been performed.
Refer to zolbetuximab drug monograph(s) for additional details
Administration
- Dilute the reconstituted solution with 0.9% Sodium Chloride Injection to a final concentration of 2 mg/mL.
- Do not shake the solution.
- Compatible with glass, polyvinyl chloride (PVC), polyethylene (PE), and polypropylene (PP) infusion bags, infusion tubing composed of PE, PVC, polyurethane, or polybutadiene and in-line filter membranes composed of polyethersulfone or polysulfone. Refer to the product monograph for more details on equipment compatibility.
- Administer infusion over a minimum of 2 hours.
- DO NOT administer as an IV push or bolus
- Do not co-administer with other drugs on the same infusion line.
- Store unopened vials in original package at 2°C to 8°C. Do not freeze. Protect vials, reconstituted or diluted drug from direct sunlight.
Recommended Infusion Rates
| Zolbetuximab | Infusion Rate (mg/m2/hr) | ||
| First 30 - 60 minutes | Remainder of infusion time* | ||
|
Loading Dose (800 mg/m2 on Day 1 of Cycle 1) |
75 | 150 - 300 | |
|
Maintenance Doses (600 mg/m2 every 3 weeks |
75 |
150 - 300 |
|
*Infusion rate can be increased as tolerated, in the absence of adverse reaction, after 30 - 60 minutes.
Contraindications
- Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/ Precaution
- Patients were excluded from clinical trials if they had certain medical conditions, including the following; assess benefit-risk of zolbetuximab treatment in these patients:
- a complete or partial gastric outlet syndrome
- positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B or C infection
- significant cardiovascular disease
- or history of central nervous system metastases
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: Unknown
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 and before each cycle
- Liver function tests; Baseline and before each cycle
- Renal function tests; Baseline and before each cycle
- Clinical toxicity assessment for hypersensitivity, infusion-related reactions, fatigue, peripheral edema, nausea/vomiting or other GI effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Outpatient prescription; drug administration at Cancer Centre or physician's office
Reimbursement recommendation: Zolbetuximab. Canada's Drug Agency. February 2025.
Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-41.
Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-68.
Zolbetuximab drug monograph. Ontario Health (Cancer Care Ontario).
September 2025 Expanded to 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.