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.
VINO
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 the treatment of recurrent advanced ovarian cancer.
| vinorelbine | 25-30 mg /m² | IV | Days 1 and 8 |
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| vinorelbine | 25-30 mg /m² | IV | Days 1, 8, 15 |
Standard schedule: REPEAT EVERY 21 DAYS
Alternative schedule: REPEAT EVERY 28 DAYS
Until disease progression or unacceptable toxicity
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and may be considered.
Dosage with toxicity
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Worst toxicity in previous cycle |
Dose (% previous dose) |
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Febrile neutropenia, thrombocytopenic bleeding, grade 4 neutropenia ≥ 7 days |
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Delay for toxicity > 3 weeks
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Discontinue
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Moderate or severe neurotoxicity
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Discontinue
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Grade 3 related other organ/ non-hematological toxicity |
75 % * |
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Grade 4 related other organ/ non-hematological toxicity |
Discontinue
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*Do not start new cycle until platelets ≥ 100 x 109/L, neutrophils ≥ 1.5 x 109/L, hemoglobin > 80g/L and major toxicity has recovered to ≤ grade 2 (may consider administering if neutrophils 1-1.5 x 109/L at 50% of planned dose). |
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Hepatic Impairment
As vinorelbine undergoes hepatobiliary metabolism and excretion, administer with caution in hepatic insufficiency. Consider adjusting doses with hyperbilirubinemia.
Suggested adjustments for increases in total bilirubin:
|
Total Bilirubin (µmol/L) |
% Usual dose |
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< 2 x ULN |
100% |
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2-3 x ULN |
50% |
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> 3 x ULN |
25% |
Renal Impairment
No adjustment required
Dosage in the Elderly
No dosage adjustments are required for increased age
| Most Common Side Effects |
Less Common Side Effects, but may be |
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Refer to vinorelbine drug monograph(s) for additional details
Administration:
FOR INTRAVENOUS USE ONLY.
Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled “WARNING – FOR INTRAVENOUS USE ONLY. FATAL if given intrathecally.”
- Mix in 50mL minibag (D5W, NS) to a final concentration 0.5 - 2mg/mL; infuse over 6-10 minutes through free-flowing IV.
- Or may push (at final concentration of 1.5 – 3mg/mL) through sidearm of free-flowing IV (D5W, NS); inject over 6-10 minutes.
- After administration is completed, the manufacturer recommends flushing IV line with at least 75 to 125mL of D5W or NS.
- Flushing the line before and after administration of vinorelbine may reduce injection site reactions and phlebitis risk.
- If diluted as above, the manufacturer states that vinorelbine (in PVC bags or polypropylene syringes) may be used for up to 24 hours at 5-30°C.
- Refrigerate unopened vials (2-8°C); protect from light and do not freeze.
Contraindications:
- Patients with known hypersensitivity to vinorelbine
- Patients who have drug-induced severe myelosuppression
- Intrathecal administration is absolutely contraindicated
Warnings/precautions:
- Use with extreme caution in patients with compromised marrow reserve
- May result in radiosensitizing effects with prior or concomitant radiation therapy
- Patients with pre-existing neuropathy or prior treatment with other neurotoxic drugs may have increased potential for neurotoxicity
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
- CBC; Baseline and at each visit
- Liver function tests; Baseline and periodic
- Clinical toxicity assessment for signs of neurotoxicity, local toxicity, bleeding, infection, hypersensitivity, thromboembolism, lung or ototoxicity; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Local site toxicity ratings, if incidence of phlebitis; At each visit
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Bajetta E, Di Leo A, Biganzoli L, et al. Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease. J Clin Oncol 1996;14(9):2546-51.
Burger RA, DiSaia PJ, Roberts JA, et al. Phase II trial of vinorelbine in recurrent and progressive epithelial ovarian cancer. Gynecol Oncol 1999;72(2):148-53.
Sørensen P, Høyer M, Jakobsen A, et al. Phase II study of vinorelbine in the treatment of platinum-resistant ovarian carcinoma. Gynecol Oncol 2001;81(1):58-62.
Vinorelbine drug monograph, Cancer Care Ontario.
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.