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.
VRNS
Cutaneous T-cell Lymphoma (CTCL)
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.
Treatment of cutaneous manifestations in patients with advanced cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease after prior systemic therapies.
| vorinostat | 400 mg | PO | Daily |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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(Outpatient prescription in 100 mg capsules)
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Minimal – No routine prophylaxis; PRN recommended
Other Supportive Care:
Patients should be instructed to drink at least 2 L/day of fluids for adequate hydration.Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
Suggested dose levels are 400 mg daily, 300 mg daily, and 300 mg daily for 5 consecutive days per week.
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Toxicity
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Action
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Dose
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Grade 3
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Hold #/*
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↓ 1 dose level
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Grade 4
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Hold #; or discontinue
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If re-start, ↓ 1 dose level
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* consider hold for Platelets 10-25 x 109 /L and/or Hemoglobin 65-80 g/L if considered related to vorinostat.
# until recovery to ≤ grade 1
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Hepatic Impairment
Although hepatic impairment did not produce statistically significant differences in pharmacokinetics, tolerability decreased with increasing severity of hepatic impairment.
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Bilirubin
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AST
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Action
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1 to 1.5 x ULN
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Caution; reduce dose to 300 mg daily
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≤ ULN
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and
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> ULN
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Caution; reduce dose to 300 mg daily
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1.5 to ≤ 3 x ULN
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and
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any
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Not recommended for use
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> 3 x ULN
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and
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any
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Contraindicated
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Renal Impairment
No data available. Treat with caution in renal impairment as the 2 major metabolites are excreted in urine.
| Most Common Side Effects |
Less Common Side Effects, but may be |
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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, electrolytes (including Ca, Mg, K) and blood glucose; baseline, then every 2 weeks during the first 2 months, then monthly thereafter
- ECG; baseline and periodic
- Liver and renal function tests; baseline and regular
- Clinical toxicity assessment of dehydration, hyperglycemia, fatigue, gastrointestinal, and cardiovascular toxicities; 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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Duvic M, Talpur R, Ni X, et al. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood 2007; 109: 31-9.
Olsen EA, Kim YH, Kuzel TM, et al. Phase IIB multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous t-cell lymphoma. J Clin Oncol 2007; 25: 3109-15.
Vorinostat drug monograph, Cancer Care Ontario.
June 2019 Updated emetic risk category
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.