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.
For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck. Based on a single arm phase II study of 115 patients with a 4% response rate and median time to progression of 10 weeks.
| erlotinib | 150 mg | PO | Daily |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
In the clinical trial, dose escalation above 150 mg was permitted if patients had been on a stable dose for 4 weeks without treatment-related toxicity. The dose was increased by 50 mg to a maximum of 250 mg daily (Soulieres 2004).
Dose levels: 150 mg, 100 mg, 50 mg
|
Toxicity
|
Action
|
|
Diarrhea |
Manage with loperamide. If severe, associated with dehydration or unresponsive to loperamide, hold* and/or reduce dose.
|
|
Patients with dehydration at risk of renal failure Acute/new or worsening ocular disorders |
Hold* or Discontinue |
|
Acute/new or worsening pulmonary symptoms (e.g. dyspnea, cough, fever) |
Hold*; investigate and treat appropriately.
Discontinue if interstitial lung disease confirmed.
|
| Other grade 3 toxicity | Reduce by one dose level especially if being administered with potent CYP3A4 inhibitors |
|
Discontinue; treat patient appropriately
|
*Hold until ≤ grade 2 up to 14 days; if further hold required, discontinue
Hepatic Impairment
Use with caution in combination with other hepatotoxic drugs. See table above for hepatic toxicity during treatment.
|
Hepatic Impairment |
Bilirubin |
|
Transaminases |
Erlotinib dose |
|
Mild |
< 1.5 x ULN |
and |
1 - 2.5 x ULN |
100%, caution |
|
Moderate |
1.5 - 3 x ULN |
and/or |
2.5 - 5 x ULN |
Caution; consider starting at reduced dose. If worsens, hold then 50% or discontinue. |
|
Severe |
> 3 x ULN (or 2 x baseline values) |
or |
> 5 x ULN (or 3 x baseline values) |
Do not treat |
Renal Impairment
Not significantly renally excreted. No dose adjustment required.
Dosage in the elderly
No dosage adjustment required.
Refer to erlotinib drug monograph(s) for additional details of adverse effects
|
Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening |
|
|
Refer to erlotinib drug monograph(s) for additional details
- Avoid use with potent CYP3A4 inducers (e.g. rifampin, phenytoin, St. John's wort) and inhibtiors (e.g. diltiazem, erythromycin, Grapefruit juice)
- If must co-administer with potent CYP3A4 inhibitor, consider erlotinib dose reduction
- Avoid concomittant use with drugs that increase gastric pH (e.g. proton pump inhibitors, H2-antagonists). If must co-administer, take erlotinib 2 hours prior to or 10 hours following acid reducers.
- Cigarette smoking increases erlotinib clearance and may reduce efficacy. Encourage smoking cessation.
- Caution and monitor closely in patients receiving oral anticoagulants and statin medications given increased risk of bleeding and rhabdomyolysis, respectively.
Refer to erlotinib drug monograph(s) for additional details
Administration:
- Administer on an empty stomach, 1 hour before or 2 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 from the product monograph.
Recommended Clinical Monitoring
- Liver function tests; Baseline and at each visit, more frequent if abnormal.
- Renal function tests, including electrolytes; Baseline and at each visit
- INR, in patients on warfarin; Baseline and when dose modified, held, or discontinued.
- Clinical toxicity assessment of diarrhea, skin/nails, stomatitis, thromboembolism, infection, bleeding, ocular and respiratory effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
back to top
Erlotinib drug monograph, Ontario Health (Cancer Care Ontario).
Soulieres D, Senzer NN, Vokes EE, et al. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol. 2004 Jan 1;22(1):77-85.
October 2022 Modified Pregnancy/lactation section
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.