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PMS-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: pms-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 pms-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 pms-EVEROLIMUS and 14 CLINICAL TRIALS, SEGA associated with Tuberous Sclerosis Complex).
3 Pediatrics below and 16 NON-CLINICAL TOXICOLOGY). 1 Dosing Considerations) Renal Angiomyolipoma associated with TSC: ● Treatment with pms-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 pms-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 se condary amenorrhoea in females taking everolimus (see 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential). 1 Dosing Considerations pms-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.
5 mg, 5 mg and 10 mg) is only available in an immediate-release tablet formulation. pms-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. pms-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, pms-EVEROLIMUS must be used in conjunction with therapeutic drug monitoring (see Therapeutic drug monitoring for patients treated for SEGA associated with TSC below). pms-EVEROLIMUS (tablets) has 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 pms-EVEROLIMUS therapy and periodically thereafter. 1 Dosing Considerations, Table 1).
Hyperglycemia:
Hyperglycemia has been reported in patients taking everolimus. Monitoring of fasting serum glucose is recommended prior to the start of pms-EVEROLIMUS therapy and periodically thereafter (see Monitoring and Laboratory Tests below). More frequent monitoring is recommended when pms-EVEROLIMUS is co-administered with other drugs that may induce hyperglycemia.
Optimal glycemic control should be achieved before starting a patient on pms-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 pms-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.
Antifungal agents should not be used unless oral fungal infection has been diagnosed (see 4 DOSAGE AND ADMINISTRATION, Table 1 and
, Radiation Sensitization and Radiation Recall 01/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS ...................................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
5 2 CONTRAINDICATIONS..................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 6 4 DOSAGE AND ADMINISTRATION ....................................................................................
1 Dosing Considerations............................................................................................. 2 Recommended Dose and Dosage Adjustment.......................................................... 3 Reconstitution ........................................................................................................
4 Administration ........................................................................................................ 5 Missed Dose ..........................................................................................................
15 5 OVERDOSAGE................................................................................................................ 15 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.............................. 15 7 WARNINGS AND PRECAUTIONS...................................................................................
pms-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).
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
pms-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 pms-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 pms-EVEROLIMUS (everolimus) Page 8 of 91 The recommended dose of pms-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 pms- EVEROLIMUS and exemestane should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Advanced NET and Metastatic RCC:
Treatment with pms-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 pms-EVEROLIMUS is not known.
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 pms-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).
Starting dose and target trough concentrations in SEGA associated with TSC The recommended starting daily dose for pms-EVEROLIMUS for the treatment of patients with SEGA associated […]
1 Special Populations ............................................................................................... 1 Pregnant Women................................................................................................. 2 Breast-feeding......................................................................................................
3 Pediatrics............................................................................................................. 4 Geriatrics .............................................................................................................
22 8 ADVERSE REACTIONS................................................................................................... 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ...................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data....................................................................................................
5 Post-Market Adverse Reactions.............................................................................. 42 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview ....................................................................................
4 Drug-Drug Interactions........................................................................................... 5 Drug-Food Interactions........................................................................................... 6 Drug-Herb Interactions ...........................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 46 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ..............................................................................................
2 Pharmacodynamics ................................................................................................ 3 Pharmacokinetics...................................................................................................
47 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 49 12 SPECIAL HANDLING INSTRUCTIONS............................................................................. 49 PART II: SCIENTIFIC INFORMATION ..................................................................................
50 13 PHARMACEUTICAL INFORMATION .............................................................................. 50 14 CLINICAL TRIALS...........................................................................................................
1 Clinical Trials by Indication ..................................................................................... 3 Comparative Bioavailability Studies ........................................................................ 76 15 MICROBIOLOGY ............................................................................................................
77 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 77 17 SUPPORTING PRODUCT […]