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.
ERLO
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 locally advanced or metastatic non-small cell lung cancer.
Funded by EAP for second- or third-line treatment of NSCLC (Refer to EAP criteria)
erlotinib
Exceptional Access Program
(erlotinib - Incurable progressive NSCLC, with specific criteria)
(EAP Website)
CONTINUOUS TREATMENT
Until evidence of disease progression or unacceptable toxicity
Minimal – No routine prophylaxis; PRN recommended
Other Supportive Care:
Provide patient with loperamide (including instructions) for diarrhea management.
Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated. EGFR mutation positive status must be confirmed with a validated test prior to starting erlotinib therapy in the first line and maintenance settings.
Dosage with toxicity
Dose levels: 150 mg, 100 mg, 50 mg
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Toxicity
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Action
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Manage with loperamide. If severe, associated with dehydration or unresponsive to loperamide, hold and/or reduce dose.
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Hold or discontinue |
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Hold; investigate and treat appropriately.
Discontinue if ILD confirmed
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Discontinue; treat patient appropriately
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Reduce by one dose level especially if being administered with potent CYP3A4 inhibitors
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Hepatic Impairment
Use with caution in combination with other hepatotoxic drugs.
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Hepatic Dysfunction
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Bilirubin
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Transaminases
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Action
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Mild
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< 1.5 x ULN
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and
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1-2.5 x ULN
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100% , caution
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Moderate
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1.5-3 x ULN
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and/or
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2.5-5 x ULN
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Caution; consider ↓.
If worsens, hold then ↓ 50% or discontinue
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Severe
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> 3 x ULN (or 2 x baseline values)
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or
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> 5 x ULN (or 3 x baseline values)
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Discontinue
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Renal Impairment
Dosage in the Elderly
No adjustment required.
Refer to erlotinib drug monograph(s) for additional details of adverse effects
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Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
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Refer to erlotinib drug monograph(s) for additional details
- Avoid grapefruit, pomegranate, starfruit, Seville oranges or their juices/products as they may increase erlotinib toxicity.
- Avoid strong inhibitors of CYP3A4 and 1A2 (e.g. ketoconazole, clarithromycin, ciprofloxacin) as they may increase erlotinib toxicity. Decrease erlotinib dose if must be co-administered.
- Avoid strong inducers of CYP3A4 (e.g. phenytoin, rifampin) as they may decrease erlotinib efficacy.
- Avoid co-administration with drugs that increase gastric pH (e.g. PPIs) as they may decrease erlotinib exposure.
- Avoid cigarette smoking as this may decrease erlotinib exposure.
- Monitor closely in patients also receiving statins (e.g. atorvastatin, simvastatin) as the combination increases the risk of myopathy.
Refer to erlotinib drug monograph(s) for additional details
Administration:
- Administer erlotinib at least one hour before or two hours after a meal.
- Avoid grapefruit, starfruit, Seville oranges, their juices or products during erlotinib treatment.
Contraindications:
- Patients who have a hypersensitivity to this drug or any of its components
Warnings/precautions:
- Erlotinib has not been studied in patients with severe hepatic or renal impairment.
- Patients on oral anticoagulants should be closely monitored when doses of erlotinib are started, modified or discontinued.
- Contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
Pregnancy/Lactation:
- Erlotinib is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 2 weeks after the last dose.
- Breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose.
- Fertility effects: Unlikely
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations in the product monograph.
Recommended Clinical Monitoring
- Liver function tests; Baseline and at each visit (monitor closely if abnormal).
- INR in patients on warfarin, especially initially, or when dose modified, held, or discontinued; Baseline and as clinically indicated
- Renal function tests and electrolytes in patients at high risk of dehydration; Baseline and at each visit.
- Clinical toxicity assessment of GI, skin/nails and ocular toxicity, thromboembolism, and respiratory symptoms; 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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Cappuzzo, F et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet. 2010 June;11(6): 521-9.
Erlotinib drug monograph, Ontario Health (Cancer Care Ontario).
Miller AA, Murry DJ, Owzar K, et al. Phase I and Pharmacokinetic Study of Erlotinib for Solid Tumors in Patients With Hepatic or Renal Dysfunction: CALGB 60101. J Clin Oncol 2007; 25: 3055-60.
Shepherd F, Pereira J, Ciuleanu T, et al. Erlotinib in Previously Treated Non–Small-Cell Lung Cancer. NEJM 2005; 353(2): 123-32.
- Use of the EGFR Inhibitors Gefitinib, Erlotinib, Afatinib, Dacomitinib or Icotinib in the Treatment of NSCLC
- Systemic Treatment for Patients with Advanced Non-Small Cell Lung Cancer
- The Use of Systemic Treatment in the Maintenance of Patients with Non-small Cell Lung Cancer
- Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO and OH(CCO) Joint Guideline Update
October 2022 Modified Warnings/Precautions and Pregnancy/lactation sections
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.