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AROMASIN is a brand name for Exemestane, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AROMASIN (exemestane tablets) is indicated for: the sequential adjuvant treatment of postmenopausal women with estrogen receptor-positive early breast cancer who have received 2-3 years of initial adjuvant tamoxifen therapy. Approval is based on improved disease-free survival for sequential AROMASIN in comparison to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations There are no dosing considerations for AROMASIN. 2 Recommended Dose and Dosage Adjustment Product Monograph AROMASIN (exemestane tablets) Page 5 of 46 The recommended dose of AROMASIN (exemestane tablets) in early and advanced breast cancer is 25 mg once daily after a meal.
In postmenopausal women with early breast cancer, treatment with AROMASIN should continue until completion of five years of adjuvant endocrine therapy, or until local or distant recurrence or new contralateral breast cancer. In patients with advanced breast cancer, treatment with AROMASIN should continue until tumor progression is evident.
No dose adjustments are required for patients with hepatic or renal insufficiency (see 10 CLINICAL PHARMACOLOGY).
Geriatric (> 65 years of age):
Healthy postmenopausal women aged 43 to 68 years were studied in the pharmacokinetic trials. Age-related alterations in exemestane pharmacokinetics were not seen over this age range.
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use.
Dose modification for Patients with Hepatic Impairment:
Following a single 25-mg oral dose, the AUC of exemestane in patients with hepatic dysfunction (moderate hepatic impairment, Child Pugh B; severe hepatic impairment, Child Pugh C) was approximately 3 times higher than that observed in healthy volunteers.
However, no dosage adjustment is required for patients with liver impairment since exemestane was well tolerated in patients with breast cancer at doses 8 to 24 times higher than the recommended 25 mg daily dose (see 10 CLINICAL PHARMACOLOGY).
73 m2) compared with the AUC in healthy volunteers. However, no dosage adjustment is required for patients with renal impairment since exemestane was well tolerated in patients with breast cancer at doses 8 to 24 times higher than the recommended dose (see 10 CLINICAL PHARMACOLOGY).
4 Administration The recommended dose is one 25 mg tablet, once daily, by mouth. The tablet should be taken with food (preferably after a meal) at the same time each day. 5 Missed Dose If a dose of AROMASIN is missed, then it should be taken as soon as the patient remembers unless it is almost time for the next dose, in which case the patient should not take the missed dose.
1 Adverse Reaction Overview Adjuvant Treatment of Early Breast Cancer AROMASIN tolerability in postmenopausal women with early breast cancer was evaluated in two controlled trials: the Intergroup Exemestane Study 031 (IES) (see 14 CLINICAL TRIALS) and the 027 study (a randomized, placebo-controlled, double-blind, parallel group, phase II study specifically designed to assess the effects of exemestane on bone metabolism, hormones, lipids and coagulation factors over 2 years of treatment).
Certain adverse events, expected based on the known pharmacological properties and side effect profiles of test drugs, were actively sought through a positive checklist. Signs and symptoms were graded for severity using CTC in both studies.
Within the IES study, the presence of some illnesses/conditions was monitored through a positive checklist without assessment of severity. These included myocardial infarction, other cardiovascular disorders, gynecological disorders, osteoporosis, osteoporotic fractures, other primary cancer, and hospitalizations.
9 months for patients receiving AROMASIN or placebo within the 027 study. 6 months. Median duration of observation was 30 months for both groups in the 027 study. AROMASIN adverse events were usually mild to moderate. 1% of patients receiving exemestane or placebo within Study 027.
Within the IES study, the most commonly reported adverse reactions were hot flushes (AROMASIN Product Monograph AROMASIN (exemestane tablets) Page 11 of 46 22%; tamoxifen 20%), arthralgias (AROMASIN 18%; tamoxifen 11%), and fatigue (AROMASIN 16%; tamoxifen 15%).
5% of the tamoxifen-treated patients within the IES study. There were 6 on- treatment deaths due to stroke and 3 due to cardiac failure in the AROMASIN-treated patients compared with 2 deaths due to stroke and 1 due to cardiac failure in the tamoxifen-treated patients.
, Musculoskeletal 11/2022 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 .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
5 5 OVERDOSAGE............................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
AROMASIN (exemestane tablets) is contraindicated in patients who are hypersensitive to this drug 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients should not take 2 doses at the same time to make up for a missed dose.
There were no deaths in Study 027.
Treatment of Advanced Breast Cancer after Failure on Tamoxifen:
A total of 1058 patients who had failed prior tamoxifen therapy were treated with AROMASIN (exemestane tablets), 25 mg once daily in the clinical trials program. AROMASIN adverse events were usually mild to moderate. Only one death was potentially related to treatment with AROMASIN; an 80- year-old woman with known coronary artery disease had a myocardial infarction with multiple organ failure after 9 weeks on study treatment.
3%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adjuvant Treatment of Early Breast Cancer Treatment-emergent adverse events and illnesses including all causalities and occurring with an incidence of >5% in either treatment group of the IES study during or within one month of the end of treatment are shown in Table 2.
8%). 7%). 1% in the tamoxifen-treated group. In the IES study, as compared to tamoxifen, AROMASIN was associated with a higher incidence of events in the musculoskeletal disorders […]
1 Special Populations .................................................................................................. 1 Pregnant Women ...............................................................................................
2 Breast-feeding .................................................................................................. 3 Pediatrics..........................................................................................................
4 Geriatrics .......................................................................................................... 10 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 Product Monograph AROMASIN (exemestane tablets) Page 3 of 46 Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions............................................................................. 17 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ...................................................................................
3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions .......................................................................................... 18 Interactions with other drugs have not been established.
............................................. 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 18 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 19 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
21 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 21 PART II: SCIENTIFIC INFORMATION ..................................................................................... 22 13 PHARMACEUTICAL INFORMATION ..........................................................................
22 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..............................................................................
22 15 MICROBIOLOGY ...................................................................................................... 37 16 NON-CLINICAL TOXICOLOGY ....................................................................................
37 PATIENT MEDICATION INFORMATION ................................................................................ 40 Product Monograph AROMASIN (exemestane tablets) Page 4 of 46 PART I: HEALTH […]