REDDY-EVEROLIMUS

, Therapeuticdrug monitoring for patients treated for SEGA). ● The optimal duration of 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 everolimus and 14 CLINICAL TRIALS, SEGA associated with TuberousSclerosis Complex).

● Non-clinical data suggests that there is a risk of delayed developmental landmarksand delayed reproductive development in patients taking everolimus (see Special Populations, Pediatrics below and 16 NON-CLINICAL TOXICOLOGY). 1 Dosing Considerations).

Renal Angiomyolipoma associated with TSC: ● Treatment with Reddy-Everolimus should be initiated by a qualified healthcare professional experienced in the treatment of patients with TSC. The optimal time to initiate therapyis not known.

● The optimal duration of Reddy-Everolimus therapy for patients who have renal angiomyolipoma associated with TSC is not known (see 14 CLINICAL TRIALS, RenalAngiomyolipoma associated with Tuberous Sclerosis Complex). ). 1 Dosing Considerations Reddy-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, 10 mg) is only available in an immediate -release tablet formulation. Reddy-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. Reddy-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, Reddy-Everolimus must be used in conjunction with therapeutic drug monitoring (see Therapeutic drug monitoring for patients treated for SEGA associated with TSCbelow). Reddy-Everolimus (tablets) have not been studied and should not be used in patients with seizuresassociated with TSC.

). Monitoring of fasting lipid profile is recommended prior to the start of Reddy-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 2).

Hyperglycaemia:

Hyperglycaemia has been reported in patients taking everolimus. Monitoring of fasting serum glucose is recommended prior to the start of Reddy-Everolimus therapy and periodically thereafter (see Monitoring and Laboratory Tests below).

More frequent monitoring is recommended when Reddy-Everolimus is co-administered with other drugs that may induce hyperglycaemia. Optimal glycaemic control should be achieved before starting a patient on Reddy-Everolimus. New onsettype 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 Reddy-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) o f 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).

Reddy-Everolimus Product Monograph Page 5 of 94  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).

Reddy-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 withSEGA > 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).

 Reddy-Everolimus (everolimus) are contraindicated in patients who arehypersensitive 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).