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BIO-ANASTROZOLE is a brand name for Anastrozole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bio-ANASTROZOLE (anastrozole) is indicated for: the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Approval is based on superior disease-free survival for anastrozole in comparison to tamoxifen. However, overall survival was not significantly different between the two…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Bio-ANASTROZOLE (anastrozole) should be administered 1 mg orally, once a day. In the adjuvant setting, it is currently recommended that treatment be given for 5 years.
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use for anastrozole.
Geriatrics (> 65 years of age):
No changes in dose are necessary for elderly patients (see 1 INDICATIONS).
Dose modification for Patients with Hepatic Impairment:
Although the apparent oral clearance of anastrozole was decreased in subjects with cirrhosis due to alcohol abuse, plasma anastrozole concentrations remained within the range seen across all clinical trials in subjects without liver disease.
Therefore, no changes in dose are recommended for patients with mild-to- moderate hepatic impairment, although patients should be monitored for side effects. Anastrozole has not been studied in patients with severe hepatic impairment.
3 Pharmacokinetics).
Dose modification for Patients with Renal Impairment:
No changes in dose are necessary for patients with renal impairment. 3 Pharmacokinetics). 4 Administration Patients should swallow Bio-ANASTROZOLE with fluids. Patients should try to take Bio-ANASTROZOLE at the same time each day. 5 Missed Dose A missed dose should be taken as soon as possible, as long as it is taken at least 12 hours before the next dose is due.
A missed dose should not be taken within 12 hours of the next dose.
1 Adverse Reaction Overview Adverse events have usually been mild to moderate with few withdrawals from treatment due to undesirable events. The pharmacological action of anastrozole may give rise to certain expected effects. Arthritis/arthralgia, joint pain/stiffness and hot flushes were reported very commonly (≥10%).
Common adverse reactions (≥1% - <10%) are: asthenia, bone pain, myalgia, carpal tunnel syndrome, sensory disturbances (including paraesthesia, taste loss and taste perversion), vaginal dryness, hair thinning (alopecia), rash, nausea, diarrhea, headache and increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase.
In the ATAC trial, ischemic cardiovascular events were reported more frequently in patients treated with anastrozole compared to those treated with tamoxifen, although the difference was not statistically significant. A retrospective evaluation has shown that this numerical difference was associated with a sub-group of patients with pre-existing ischemic heart disease.
A statistical analysis could not be performed on this subgroup evaluation. 9% vs. 7%, respectively). Events of carpal tunnel syndrome have been reported in patients receiving anastrozole treatment in clinical trials in greater numbers than those receiving treatment with tamoxifen.
The majority of these events occurred in patients with identifiable risk factors for the development of the condition. In the ATAC adjuvant trial, 83 events of carpal tunnel syndrome occurred in 78 patients in the anastrozole monotherapy arm, and 22 events occurred in 22 patients in the tamoxifen arm.
Vaginal bleeding has been reported infrequently, mainly in patients during the first few weeks after changing from existing hormonal therapy to treatment with anastrozole. If bleeding persists, further evaluation should be considered.
, Musculoskeletal 12/2023 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 ..................................................................................... 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 ......................................................................................
Patients who are hypersensitive to Bio-ANASTROZOLE (anastrozole) 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.
Pregnant or lactating women.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Anastrozole in Canada.
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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. 6 months for patients receiving anastrozole 1 mg and tamoxifen 20 mg, respectively. The combination of anastrozole and tamoxifen did not demonstrate any safety benefits in comparison to tamoxifen alone after the results from the first analysis (median duration of treatment was approximately 33 months).
1% vs. 5% vs. 9%). 3% versus 36%). Adverse events occurring with an incidence of at least 5% in either treatment group during treatment or within 14 days of the end of treatment are presented below in Table 2. 8) Page 11 of 59 Table 2 Adverse events occurring with an incidence of at least 5%in any treatment group during or within 14 days of the end of treatment from the ATAC trial Body system and adverse event by COSTART-preferred term Number (%) of patientsa 33-month analysis (data cut-off 29 June 2001) 5-year treatment completion analysis (data cut-off 31 March 2004) Anastrozole 1 mg (N=3092) Tamoxifen 20 mg (N=3094) […]
1 Special Populations.................................................................................................... 1 Pregnant Women .....................................................................................................
8 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....................................................................................................................
21 9 DRUG INTERACTIONS ......................................................................................................... 2 Drug Interactions Overview ..................................................................................
7 Drug-Laboratory Test Interactions ........................................................................ 22 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ......................................................................................
3 Pharmacokinetics........................................................................................... 24 Page 3 of 59 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
27 13 PHARMACEUTICAL INFORMATION ............................................................................ 27 14 CLINICAL TRIALS ........................................................................................................
28 Adjuvant Treatment of Postmenopausal Women with Hormone Receptor Positive Early Breast Cancer.......................................................................... 28 Hormonal Treatment of Advanced Breast Cancer in Postmenopausal Women.
...................................................................................................................... 51 17 SUPPORTING PRODUCT MONOGRAPHS………………………………………………54 PATIENT […]