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Dear Health Care Professional Letter Sandoz Letrozole

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Contact: Bureau of Metabolism, Oncology and Reproductive 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 Sandoz Canada Inc.
Contact Sandoz Canada for a copy of any references, attachments or enclosures.

November 24, 2009

Dear Health Professional(s):

Sandoz Canada Inc. is pleased to announce that Health Canada has issued a Notice of Compliance with conditions (NOC/c) for Sandoz Letrozole (letrozole) 2.5 mg tablets for the use in the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer and for use in 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. The intended duration of therapy is 5 years, although current data is limited to a median follow-up of 26 months.

Health Canada has issued a marketing authorization with conditions under the Notice of Compliance with Conditions policy for letrozole 2.5 mg tablets based on the promising nature of the clinical efficacy and safety of letrozole in adjuvant treatment for early breast cancer. This authorization is conditional upon further confirmation of clinical benefit.

Indications and Clinical Use

Sandoz Letrozole (letrozole) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Sandoz Letrozole (letrozole) is also indicated for 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.

Patients should be advised about the conditional nature of the marketing authorization for Sandoz Letrozole in early adjuvant therapy and extended adjuvant therapy.

Contraindications

• Premenopausal endocrine status, pregnancy, lactation.
• Patients who are hypersensitive to letrozole, other aromatase inhibitors, or to any ingredients in the formulation or component of the container.

Warnings and Precautions

Cardiovascular Disease: In the adjuvant setting, the use of some aromatase inhibitors, including letrozole, may increase the risk of cardiovascular events compared to tamoxifen.

Bone Mineral Density: Letrozole reduces circulating estrogen levels. The use of estrogen lowering agents, including letrozole, may cause a reduction in bone mineral density.

Plasma Lipids: In the adjuvant setting, the use of aromatase inhibitors, including letrozole, may increase lipid levels.

Adverse Reactions

The most frequently reported adverse reactions in the adjuvant setting were hot flushes (letrozole 33.7%, tamoxifen 38.0%), arthralgia/arthritis (letrozole 21.2%, tamoxifen 13.5%), and night sweats (letrozole 14.1%, tamoxifen 16.4%). Letrozole treatment was associated with a significantly higher risk of osteoporosis (2.0 versus 1.1% with tamoxifen). Bone fractures were significantly higher in the letrozole arm than the tamoxifen arm (5.7% versus 4.0%, respectively).

If you have questions concerning Sandoz Letrozole, kindly contact the Drug Information line at Sandoz Canada Inc. at Telephone Number: 1-800-343-8839 ext.4636.

This document including the Sandoz Letrozole Prescribing Information and Patient Information can be found on our  Sandoz website.

Sincerely,

Len Arsenault
Vice-President, Scientific Affairs

Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8