Fact Sheet Sandoz Letrozole

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Contact: Bureau of Metabolism, Oncology and Reproductive Sciences

What is Sandoz Letrozole?

Sandoz Letrozole is a tablet that contains 2.5 mg of the active substance letrozole.

Health Canada has authorized Sandoz Letrozole with conditions, under the Notice of Compliance with Conditions (NOC/c) policy 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. This authorization reflects the promising nature of the clinical evidence and safety of Sandoz Letrozole, which must be verified and/or extended with further studies. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is Sandoz Letrozole used for?

Adjuvant treatment of hormone receptor positive early breast cancer in postmenopausal women. 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.

What is Adjuvant Treatment of Early Breast Cancer?

Early breast cancer is confined to the breast, and may or may not have spread to the lymph nodes in the breast or armpit area. Breast cancer that has metastasized (spread) to other parts of the body is considered to be advanced/metastatic breast cancer.

Adjuvant treatment of early breast cancer is used to help reduce the risk of recurrence (cancer coming back or spreading to other parts of the body) after surgery.

What is extended adjuvant therapy?

The purpose of extended adjuvant therapy is to treat hormone receptor-positive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy in order to prevent recurrence. Treating breast cancer with Sandoz Letrozole beyond the standard 5 years of hormone therapy is called "extended adjuvant therapy".

Letrozole is the only drug approved for this kind of therapy. The long term benefit (whether letrozole prolongs life) of extended adjuvant therapy is unconfirmed as this single, large placebo controlled trial was terminated early, and data from clinical trials with tamoxifen beyond five years did not show benefit.

Sandoz Letrozole as extended adjuvant therapy

Approval under the Notice of Compliance with Conditions (NOC/c) policy of Sandoz Letrozole, was granted for 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. This authorization reflects the promising nature of the clinical efficacy and safety of Sandoz Letrozole in patients with this serious disease, and the need for further follow up to verify the clinical benefit. The authorization is based on data from a single, double-blind placebo controlled clinical trial with more than 5,100 postmenopausal women, who either received 2.5 mg of letrozole daily or placebo (no active therapy). The planned duration of treatment was 5 years. The first planned analysis, which occurred at 28 months median follow up, gave a statistically significant decrease in recurrence and new breast cancer in women treated with letrozole. The results were communicated to participants, and patients on the placebo arm were offered the choice of starting therapy with letrozole. Although the study continues, due to this optional switch, future data on long term benefits may not be available. Although survival was one of the secondary endpoints of the study, the data are not mature enough to conclude that women treated with letrozole will outlive women treated with placebo.

In node-positive patients, at 28 months follow up, letrozole significantly reduced the risk of death. At an updated safety analysis with median follow-up of 30 months, letrozole continued to reduce deaths but the difference was no longer statistically significant.

In node-negative patients, at 28 months follow up, there was a statistically insignificant numerical increase in deaths due to all causes. Overall, the benefit/risk profile of letrozole was considered superior to that of placebo. At an updated safety analysis with median follow-up of 30 months, overall deaths in node-negative patients were similar.

How does Sandoz Letrozole work?

Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. Sandoz Letrozole belongs to a class of medications called aromatase inhibitors which act by binding to aromatase, a substance needed to make estrogen. As a result, the production of estrogen and the growth of certain types of breast cancer is reduced.

What other hormonal treatments have been used to treat Early Breast Cancer?

• Tamoxifen
• Anastrozole

What are the advantages of Sandoz Letrozole over other hormonal therapies?

It has been shown that women taking letrozole as an adjuvant therapy, reduce the risk of breast cancer recurrence by an additional 19% compared to tamoxifen. In addition, letrozole reduced the spread of the cancer to other parts of the body (distant metastasis) by 27% as compared to the gold standard, tamoxifen. However, women treated with letrozole who did not have cancer in the lymph nodes had not yet shown an efficacy benefit compared to those treated with tamoxifen.

Letrozole has not yet been compared to other Aromatase Inhibitors in a clinical study.

What do patients need to know about using Sandoz Letrozole?

Sandoz Letrozole is contraindicated in pre-menopausal women.

The use of some aromatase inhibitors, including Sandoz Letrozole may increase the risk of cardiovascular events compared to tamoxifen, such as heart attacks and stroke. Women at risk of heart disease should be carefully monitored by their doctor.

The use of aromatase inhibitors, including Sandoz Letrozole may increase lipid levels. Your doctor should continue routine checking of your lipid and cholesterol levels on a regular basis.

Long term use of Sandoz Letrozole may result in a reduction in bone mineral density and may increase the risk of osteoporosis and fracture. Your doctor should continue his/her routine clinical practice of monitoring bone mineral density on a regular basis.

Talk to your doctor if you have a personal or family history of high cholesterol, heart disease or osteoporosis or a recent history of fractures.

What are the side effects and how serious are they?

Most side effects are mild to moderate and rarely severe enough to stop treatment with Sandoz Letrozole. The most frequently reported adverse reactions were: hot flushes, pain in the muscles, bones and joints and joint stiffness (arthralgia or arthritis). Other common side effects which may occur are: mild headache, swelling or puffiness of the feet, ankles or other part of the body due to retained body fluid, weight increase, fatigue, nausea, vomiting, indigestion, increase or loss of appetite, constipation, diarrhea, hair loss, rash, dizziness, increased sweating, sad mood (depression), vaginal bleeding, vaginal irritation, breast pain, anorexia, blurry vision and cataracts.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Check with your doctor if the unwanted side effects do not go away during treatment or are bothersome.

What else patients should know about taking Sandoz Letrozole?

Patients who are hypersensitive to letrozole, or to any ingredient in the tablet formulation, should not take Sandoz Letrozole.

How is Sandoz Letrozole taken?

One 2.5 mg tablet once daily by mouth. The tablet should be swallowed with a small glass of water. You can take Sandoz Letrozole with or without food. It is best to take Sandoz Letrozole at about the same time every day. Your doctor will decide for how long you should be treated with Sandoz Letrozole.

What if I forget to take a dose?

If you forget to take a dose of Sandoz Letrozole, don't worry, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not double doses.

Can Sandoz Letrozole be taken with other drugs?

Patients should ask their doctor or pharmacist before they start using any other prescription or over-the-counter medicines or natural health products during treatment with Sandoz Letrozole.

What are other uses of Sandoz Letrozole?

The other use of Sandoz Letrozole is to treat advanced hormone receptor-positive breast cancer in women who have passed menopause.

How is Sandoz Letrozole available?

Sandoz Letrozole is available as a tablet containing the medicinal ingredient letrozole (2.5 mg).

Sandoz Letrozole is available in blister packages containing 30 tablets.

Where can I learn more about Sandoz Letrozole?

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.

Please consult your doctor with any questions or concerns you may have regarding your individual condition.

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