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NAT-EVEROLIMUS is a brand name for Everolimus, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NAT-EVEROLIMUS (everolimus) is indicated for: • the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer in combination with exemestane after recurrence or progression following treatment with letrozole or anastrozole. The effectiveness of everolimus in advanced breast…
Verbatim from this product's HC label. Tap a section to expand.
, Therapeutic drug monitoring for patients treated for SEGA). ● The optimal duration of NAT-EVEROLIMUS therapy for patients with SEGA is not known; however, SEGA re-growth has been reported to occur once therapy is discontinued (see 4 DOSAGE AND ADMINISTRATION, SEGA volume monitoring for patients treated with NAT- EVEROLIMUS and 14 CLINICAL TRIALS, SEGA associated with Tuberous Sclerosis Complex).
● Non-clinical data suggests that there is a risk of delayed developmental landmarks and delayed reproductive development in patients taking everolimus (see Special Populations, Pediatrics below and 16 NON-CLINICAL TOXICOLOGY). ● NAT-EVEROLIMUS and everolimus tablets for oral suspension are not interchangeable (see 4 DOSAGE AND ADMINISTRATION, Dosing Considerations).
Renal Angiomyolipoma associated with TSC: ● Treatment with NAT-EVEROLIMUS should be initiated by a qualified healthcare professional experienced in the treatment of patients with TSC. The optimal time to initiate therapy is not known.
● The optimal duration of NAT-EVEROLIMUS therapy for patients who have renal angiomyolipoma associated with TSC is not known (see 14 CLINICAL TRIALS, Renal Angiomyolipoma associated with Tuberous Sclerosis Complex). ● Clinical trial data suggest that there is a potential risk of secondary amenorrhoea in females taking everolimus (see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential).
1 Dosing Considerations NAT-EVEROLIMUS should be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy and/or in the treatment of patients with TSC. NAT-EVEROLIMUS (everolimus) is only available in one dosage form, tablets.
NAT-EVEROLIMUS (everolimus tablets) and everolimus tablets for oral suspension are not interchangeable and should not be combined to achieve the desired dose. 4 Administration). For dosing recommendations of everolimus tablets for oral suspension for the use in SEGA associated with TSC, please see the product monograph for the tablets for oral suspension.
NAT-EVEROLIMUS (tablets) may be used in all approved oncology indications and for the renal angiomyolipoma associated with tuberous sclerosis complex (TSC) and subependymal giant cell astrocytoma (SEGA) associated with TSC indications.
For patients with SEGA associated with TSC, NAT- EVEROLIMUS must be used in conjunction with therapeutic drug monitoring (see Therapeutic drug monitoring for patients treated for SEGA associated with TSC below). NAT-EVEROLIMUS (tablets) have not been studied and should not be used in patients with seizures associated with TSC.
). Monitoring of fasting lipid profile is recommended prior to the start of NAT-EVEROLIMUS therapy and periodically thereafter. Consider dose reduction, dose interruption or discontinuation, as well as management with appropriate medical therapy (see 4 DOSAGE AND ADMINISTRATION, Dosing Considerations, Table 1).
Hyperglycaemia:
Hyperglycaemia has been reported in patients taking everolimus. Monitoring of fasting serum glucose is recommended prior to the start of NAT-EVEROLIMUS therapy and periodically thereafter (see Monitoring and Laboratory Tests below).
More frequent monitoring is recommended when NAT-EVEROLIMUS is co-administered with other drugs that may induce hyperglycaemia. Optimal glycaemic control should be achieved before starting a patient on NAT-EVEROLIMUS. New onset type 2 diabetes has occurred with everolimus treatment ( see 8 ADVERSE REACTIONS).
Functional carcinoid tumour In a randomized, double-blind, multi-centre trial in 429 patients with functional carcinoid tumours, everolimus plus depot octreotide was compared to placebo plus depot octreotide. The study did not meet the primary efficacy endpoint (PFS) and the OS interim analysis numerically favoured the placebo plus depot octreotide arm.
Therefore, the use of NAT-EVEROLIMUS in patients with functional carcinoid tumours is not recommended outside an investigational study. Gastrointestinal Stomatitis, including mouth ulceration, is a common adverse event in patients treated with everolimus.
Across the clinical trial experience, 44% to 86% of the patients receiving everolimus experienced stomatitis (see 8 ADVERSE REACTIONS). Stomatitis mostly occurs within the first 8 weeks of treatment. For mouth ulcers and stomatitis, topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine- or thyme-containing mouthwashes should be avoided as they may exacerbate the condition.
and 14 CLINICAL TRIALS). • the treatment of patients with metastatic renal cell carcinoma (RCC) of clear cell morphology, after failure of initial treatment with either of the vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGF-receptor TKIs) sunitinib or sorafenib.
The effectiveness of everolimus is based on PFS. Prolongation of OS was not demonstrated for everolimus in RCC nor were quality-of-life differences shown between patients receiving everolimus versus placebo in the pivotal phase III trial (see 14 CLINICAL TRIALS).
NAT-EVEROLIMUS Product Monograph Page 5 of 93 • the treatment of adult patients (≥ 18 years of age) with renal angiomyolipoma associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. 3 months in the pivotal phase III placebo- controlled trial (see 14 CLINICAL TRIALS).
NAT-EVEROLIMUS is indicated for: • the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) that have demonstrated serial growth, who are not candidates for surgical resection and for whom immediate surgical intervention is not required.
The effectiveness of everolimus is based on an analysis of change in SEGA volume. Prescribers should take into consideration that surgical resection can be curative, while treatment with everolimus has been shown only to reduce the SEGA volume.
3 Pediatrics).
Pediatrics (>1 to <18 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of everolimus in pediatric patients with SEGA > 1 year of age has been established. Therefore, Health Canada has authorized an indication for pediatric patients with SEGA > 1 year of age.
3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): In the advanced breast cancer study, no overall differences in effectiveness were observed between elderly and younger patients. 4 Geriatrics and 14 CLINICAL TRIALS). In two other randomized trials (metastatic RCC and advanced PNET), no overall differences in safety or effectiveness were observed between elderly and younger patients (see 14 CLINICAL TRIALS).
• NAT-EVEROLIMUS (everolimus) is contraindicated in patients who are hypersensitive to the drug, to other rapamycin derivatives or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING (see also 7 WARNINGS AND PRECAUTIONS). NAT-EVEROLIMUS Product Monograph Page 7 of 93
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Everolimus in Canada.
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NAT-EVEROLIMUS should be administered orally once daily at the same time every day (preferably in the morning), either consistently with food or consistently without food (see 10 CLINICAL PHARMACOLOGY). Management of Adverse Reactions Management of severe or intolerable suspected adverse drug reactions may require temporary dose interruption (with or without dose reduction) or discontinuation of NAT-EVEROLIMUS therapy.
If dose reduction is required, the suggested dose is approximately 50% lower than the dose previously administered (see Table 1 and 7 WARNINGS AND PRECAUTIONS). For dose reductions below the lowest available tablet strength, alternate day dosing should be considered.
2 Recommended Dose and Dosage Adjustment Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer, Advanced NET, Metastatic RCC and Renal Angiomyolipoma associated with TSC The recommended dose of NAT-EVEROLIMUS for the treatment of hormone receptor-positive, HER2- negative advanced breast cancer, advanced NET, metastatic RCC and renal angiomyolipoma associated with TSC is 10 mg, to be taken once daily.
Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer:
Treatment with NAT-EVEROLIMUS and exemestane should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Advanced NET and Metastatic RCC:
Treatment with NAT-EVEROLIMUS should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Renal Angiomyolipoma associated with Tuberous Sclerosis Complex:
Optimal duration of treatment with NAT-EVEROLIMUS is not known.
NAT-EVEROLIMUS Product Monograph Page 9 of 93 Geriatrics (≥ 65 years):
No dosage adjustment is required for elderly patients ( see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
Pediatrics (˂ 18 years):
Health Canada has not authorized an indication for NAT-EVEROLIMUS for pediatric use in patients with Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer, Advanced NET, Metastatic RCC and renal angiomyolipoma associated with TSC.
SEGA associated with Tuberous Sclerosis Complex Individualise dosing based on body surface area (BSA, in m2), calculated using the Dubois formula1. Titration may be required to attain target everolimus trough concentrations, followed by optimal therapeutic effect within this range.
Doses that are tolerated and effective vary between patients. Concomitant antiepileptic therapy may affect the metabolism of everolimus and may contribute to this variance (see 9 DRUG INTERACTIONS and Therapeutic drug monitoring for patients treated for SEGA associated with TSC).
5 mg/m2, rounded to the nearest strength of […]
Antifungal agents should not be used unless oral fungal infection has been diagnosed (see 4 DOSAGE AND ADMINISTRATION, Table 1 and
In the randomized advanced GI/Lung NET study, no overall differences in effectiveness were observed between elderly and younger patients. 5-fold the incidence in older patients receiving everolimus relative to those aged <65 years included cardiac failure, lower respiratory tract infections (pneumonia, lung infection, bronchitis), cough and decreased appetite.
2 CONTRAINDICATIONS • NAT-EVEROLIMUS (everolimus) is contraindicated in patients who are hypersensitive to the drug, to other rapamycin derivatives or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING (see also 7 WARNINGS AND PRECAUTIONS). NAT-EVEROLIMUS Product Monograph Page 7 of 93 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Hormone receptor-positive, HER2-negative advanced breast cancer, advanced NET and metastatic kidney cancer: ● NAT-EVEROLIMUS (everolimus) should be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy.
SEGA associated with TSC: ● Treatment with NAT-EVEROLIMUS should be initiated by a qualified healthcare professional experienced in the treatment of patients with TSC and with access to everolimus therapeutic drug monitoring services.
● Therapeutic drug monitoring of everolimus blood concentrations is required for patients treated for SEGA (see 4 DOSAGE AND ADMINISTRATION, Therapeutic drug monitoring for patients treated for SEGA). ● The optimal duration of NAT-EVEROLIMUS therapy for patients with SEGA is not known; however, SEGA re-growth has been reported to occur once therapy is discontinued (see 4 DOSAGE AND ADMINISTRATION, SEGA volume monitoring for patients treated with NAT- EVEROLIMUS and 14 CLINICAL TRIALS, SEGA associated with Tuberous Sclerosis Complex).
● Non-clinical data suggests that there is a risk of delayed developmental landmarks and delayed reproductive development in patients taking everolimus (see Special Populations, Pediatrics below and 16 NON-CLINICAL TOXICOLOGY). ● NAT-EVEROLIMUS and everolimus tablets for oral suspension are not interchangeable (see 4 DOSAGE AND ADMINISTRATION, Dosing Considerations).
Renal Angiomyolipoma associated with TSC: ● Treatment with NAT-EVEROLIMUS should be initiated by a qualified healthcare professional experienced in the treatment of patients with TSC. The optimal time to initiate therapy is not known.
● The optimal duration of NAT-EVEROLIMUS therapy for patients who have renal angiomyolipoma associated with TSC is not known (see 14 CLINICAL TRIALS, Renal Angiomyolipoma associated with Tuberous Sclerosis Complex). ● Clinical trial data suggest that there is a potential risk of secondary amenorrhoea in females taking everolimus (see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and […]