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regimen-monograph
EVER
A - Regimen Name
EVER Regimen
Everolimus
Disease Site
Central Nervous System
(Subependymal giant cell astrocytoma - SEGA)
(Subependymal giant cell astrocytoma - SEGA)
Intent
Palliative
Regimen Category
Archived : No longer in use and listed for reference purposes only, although the use of such a regimen may be appropriate in a situation where a Standard Regimen cannot be used for clinical reasons. Note: The Disease Site Group considers this regimen archived. It is listed for historical reference only and is no longer updated.
Rationale and Uses
Treatment of patients ≥3 years of age with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) that have demonstrated serial growth, who are not candidates for surgery and for whom immediate surgery is not required. (Health Canada conditional approval)
B - Drug Regimen
| everolimus | |||||||||||||||||||
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Start at the dose below and then titrate as indicated in Table 2. (continued on next page)
Table 1 (outpatient prescription in 2.5mg or 5mg tablets):
Table 2: Dose levels: 7.5 mg daily, 5mg daily, 2.5mg daily, 2.5 mg q2d
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C - Cycle Frequency
CONTINUOUS TREATMENT
(Optimal duration of treatment is unknown. Treatment duration ranged from 4.7 to 34.4 months in the phase I-II study. SEGA progression has been reported after discontinuation of everolimus therapy.)
E - Dose Modifications
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
Toxicity / Event |
Action |
Infection
|
Hold everolimus |
Other severe or intolerable side effects (including hematological) |
Hold or discontinue. If restart, resume with a 50% dose reduction. |
| Pneumonitis: mild or asymptomatic | Continue treatment. May consider steroids for symptomatic relief. |
| Moderate symptomatic pneumonitis | Hold until symptoms improve and then restart with a 50% dose reduction. Consider steroids. |
| Severe pneumonitis | Discontinue. Use steroids until symptomatic improvement. If consider rechallenge (for example, in responding patients), must restart with a 50% dose reduction. |
Hepatic Impairment
Do not use everolimus in SEGA patients with severe hepatic impairment.
|
BSA
|
Mild hepatic impairment
|
Moderate hepatic impairment
|
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0.5 – 1.2
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2.5 mg q 2 days |
|
|
1.3 – 2.1
|
2.5 mg once daily |
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≥ 2.2
|
5 mg once daily
|
2.5 mg once daily
|
Renal Impairment
No dose adjustment required.
F - Adverse Effects
Refer to everolimus drug monograph(s) for additional details of adverse effects
| Most Common Side Effects | Less Common Side Effects, but may be |
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H - Drug Administration and Special Precautions
Refer to everolimus drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- CBC; baseline and periodic
- Everolimus trough levels, 2 weeks after initial dose, change in dose, change in hepatic status or after addition/change in co-administration of CYP3A4 or P-gp inducers/inhibitors
- Fasting blood glucose and lipids; baseline and periodic
- Liver function tests; baseline and periodic
- Renal function tests, electrolytes (including Ca, Mg and phosphate), urinalysis; baseline and periodic
- Clinical assessment of mucositis, pulmonary toxicity, infection, rash, diarrhea, bleeding, thromboembolism
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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K - References
Krueger DA, Care MM, Holland K, et al. Everolimus for subependymal giant-cell astrocytomas in tuberous sclerosis. N Engl J Med. 2010;363(19):1801.
June 2012: Modified sections B, E and I
M - Disclaimer
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.
Last Updated: July 27, 2026
