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ARIMIDEX 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: ARIMIDEX (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 ARIMIDEX in comparison to tamoxifen. However, overall survival was not significantly different between the two treatments…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment ARIMIDEX (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. ARIMIDEX® Product Monograph Page 5 of 55 Unclassified / Non classifié Pediatrics (< 18 years of age): Health Canada has not authorized an indication for pediatric use for ARIMIDEX.
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. ARIMIDEX 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 ARIMIDEX with fluids. Patients should try to take ARIMIDEX 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 ARIMIDEX (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 ARIMIDEX 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 ARIMIDEX 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 ARIMIDEX 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 ARIMIDEX. If bleeding persists, further evaluation should be considered. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
, Musculoskeletal 11/2022 ARIMIDEX® Product Monograph Page 3 of 55 Unclassified / Non classifié 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 25 PART II: SCIENTIFIC INFORMATION .......................................................................................
26 13 PHARMACEUTICAL INFORMATION ............................................................................ 26 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................... 27 Adjuvant Treatment of Postmenopausal Women with Hormone Receptor Positive Early Breast Cancer ..............................................................................................
27 Hormonal Treatment of Advanced Breast Cancer in Postmenopausal Women ... 43 15 MICROBIOLOGY ............................................................................................................ 47 16 NON-CLINICAL TOXICOLOGY .....................................................................................
47 PATIENT MEDICATION INFORMATION .................................................................................. 51 ARIMIDEX® Product Monograph Page 4 of 55 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ARIMIDEX (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 ARIMIDEX in comparison to tamoxifen. However, overall survival was not significantly different between the two treatments (see 14 CLINICAL TRIALS). • hormonal treatment of advanced breast cancer in postmenopausal women.
1 Pediatrics Pediatrics (< 18 years of age): Health Canada has not authorized an indication for pediatric use for ARIMIDEX as safety and efficacy have not been established in this group of patients. 2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
• Patients who are hypersensitive to ARIMIDEX (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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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.
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 ARIMIDEX 1 mg and tamoxifen 20 mg, respectively. The combination of ARIMIDEX 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%). 0%). 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. 6) 512 […]
2 CONTRAINDICATIONS • Patients who are hypersensitive to ARIMIDEX (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. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Not recommended for use in pre-menopausal women as safety and efficacy have not been established in these patients (see 10 CLINICAL PHARMACOLOGY).
3 Pharmacokinetics). • Potential risk/benefit should be carefully assessed in patients with osteoporosis or risk factors for osteoporosis (see Musculoskeletal). 2 Recommended Dose and Dosage Adjustment ARIMIDEX (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. ARIMIDEX® Product Monograph Page 5 of 55 Unclassified / Non classifié Pediatrics (< 18 years of age): Health Canada has not authorized an indication for pediatric use for ARIMIDEX.
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. ARIMIDEX 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 ARIMIDEX with fluids. Patients should try to take ARIMIDEX 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. 5 OVERDOSAGE There is limited clinical experience of accidental overdosage. 7 g). Clinical trials have been conducted with various dosages of ARIMIDEX (anastrozole), up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
A single dose of ARIMIDEX that results in life- threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken.
Vomiting may be induced if the patient is alert. Dialysis may be helpful because ARIMIDEX is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
For management of a suspected drug overdose, contact your regional poison control centre. ARIMIDEX® Product Monograph Page 6 of 55 […]