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Dear Health Care Professional Letter Apo-Letrozole

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Contact: Bureau of Pharmaceutical Sciences

Health Canada posts safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although Health Canada authorizes therapeutic products, Health Canada does not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Apotex Inc.
Contact the company for a copy of any references, attachments or enclosures.

Authorization with conditions of ^PrAPO-LETROZOLE

Marketing authorization with conditions has been issued for ^PrAPO-LETROZOLE for the following indication: ^PrAPO-LETROZOLE is indicated for use in adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; and the extended adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy

November 18, 2010

Dear Health Care Professional(s):

Apotex Inc. is pleased to announce that Health Canada has issued a Notice of Compliance with conditions under the Notice of Compliance with Conditions (NOC/c) policy to
^PrAPO-LETROZOLE (letrozole) 2.5 milligram (mg) tablets to be used for:

• the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; and
• the extended adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy.

Health Canada has also issued approval to ^PrAPO-LETROZOLE (letrozole) to be used for:

• the first-line therapy in postmenopausal women with advanced breast cancer; and
• the hormonal treatment of advanced/metastatic breast cancer in women with natural or artificially-induced postmenopausal status, who have disease progression following antiestrogen therapy.

Marketing authorization with conditions was issued based on pharmaceutical equivalence and bioequivalence to the Canadian Reference Product (CRP), Femara^® (letrozole). Products authorized under Health Canada's NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. As a condition for approval, Apotex Inc. has undertaken to provide Health Canada with Periodic Safety Update Reports (PSUR-C's) for ^PrAPO-LETROZOLE (letrozole) on a three-yearly basis.

The Canadian Reference Product (CRP) has been issued a Notice of Compliance (NOC) under the NOC/c Policy to reflect the promising nature of the clinical evidence for the CRP in the adjuvant or extended adjuvant treatment of early breast cancer and the need for further follow up to verify the clinical benefit of the letrozole CRP. Patients should be advised of the nature of the market authorization granted for this product.

The Canadian Reference Product (CRP) has also been issued a NOC for indications in the advanced breast cancer setting.

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Contraindications

• Premenopausal endocrine status, pregnancy, lactation.
• Patients who are hypersensitive to letrozole, other aromatase inhibitors, or to any ingredient in the formulation or component of the container.
• In the absence of clinical experience with the use of LETROZOLE (letrozole) in children or adolescents (under 18 years of age), LETROZOLE (letrozole) should not be used in these patients.

Serious Warnings and Precautions

^PrAPO-LETROZOLE (letrozole) should be administered under supervision of a qualified physician experienced in the use of anti-cancer agents.

• Osteoporosis

Dosage and Administration

Adult and Elderly Patients: The recommended dose is one 2.5 mg tablet once daily. No dose adjustment is required for elderly patients.

In the adjuvant setting, the intended duration of treatment is 5 years, although data are limited to a median follow-up of 26 months.

In the extended adjuvant setting, treatment with ^PrAPO-LETROZOLE (letrozole) is intended for 5 years, although scientific evidence collected to date covers a median follow-up of 49 months.

In the first- and second-line advanced breast cancer settings, ^PrAPO-LETROZOLE (letrozole) treatment should continue until further tumour progression is evident.

Please see the ^PrAPO-LETROZOLE (letrozole) Product Monograph for the complete necessary information for the safe and effective use of this product.

Should you have medical enquiries regarding ^PrAPO-LETROZOLE (letrozole), please contact our Drug Information Service, DISpedia at 1-800-667-4708.

Original signed by

Bruce D. Clark Ph.D.
Vice-President, Regulatory and Medical Affairs