Auro-Letrozole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What AURO-LETROZOLE is used for:

• The adjuvant treatment of postmenopausal women

  with hormone receptor-positive early breast cancer;

• 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 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.

What does AURO-LETROZOLE do:

Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. AURO-LETROZOLE is an aromatase inhibitor which acts by binding to aromatase, a substance needed to make estrogen. As a result, the production of estrogen and the growth of breast cancer are reduced.

What is adjuvant therapy:

Adjuvant therapy in breast cancer refers to treatment following breast surgery (the primary or initial treatment) in order to reduce the risk of recurrence. The purpose of adjuvant therapy with AURO-LETROZOLE is to treat hormone receptor-positive early breast cancer, after surgery, in postmenopausal women to reduce the risk of recurrence.

What is extended adjuvant therapy:

The purpose of extended adjuvant therapy with AURO-LETROZOLE 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 AURO-LETROZOLE beyond the standard 5 years of hormone therapy is called "extended adjuvant therapy".

When it should not be used:

AURO-LETROZOLE should not be used in children and adolescents under 18 years of age.

Do not take AURO-LETROZOLE if you:

• have ever had an unusual or allergic reaction to letrozole or any other ingredient in AURO-LETROZOLE;
• still have menstrual periods;

• are pregnant or breast-feeding, as AURO-

  LETROZOLE may harm your baby.

What the medicinal ingredient is:

Letrozole

What the nonmedicinal ingredients are:

AURO-LETROZOLE also contains the following non-medicinal ingredients needed to make the tablets: FD&C Yellow #6 aluminium lake, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium starch glycollate, talc, titanium dioxide and yellow iron oxide.

What dosage forms it comes in:

AURO-LETROZOLE (letrozole) 2.5 mg tablets

AURO-LETROZOLE is supplied as film-coated tablets. The film-coated tablets are yellow and round biconvex. They are marked with “2.5” on one side and plain on the reverse side AURO-LETROZOLE is supplied in blister packs containing 30 tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

AURO-LETROZOLE should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.

AURO-LETROZOLE reduces blood estrogen levels which may cause a reduction in bone mineral density and a potential increase in bone loss (osteoporosis) and/or bone fractures.

The use of aromatase inhibitors, including AURO-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.

You should not use AURO-LETROZOLE if you may become pregnant, are pregnant and/or breastfeeding. There is a potential risk of harm to you and the fetus, including risk of fetal malformations. If you have the potential to become pregnant (this includes women who are perimenopausal or who recently

became postmenopausal), you should discuss with your doctor about the need for effective contraception.

If there is exposure to AURO-LETROZOLE during pregnancy, you should contact your doctor immediately to discuss the potential of harm to your fetus and potential risk for loss of the pregnancy.

AURO-LETROZOLE should not be used in children and adolescents under 18 years of age.

Before you take AURO-LETROZOLE:

Tell your doctor if you:

• have a serious kidney or serious liver disease
• are taking hormone replacement therapy
• are taking other medication to treat your cancer

• have a personal or family history of osteoporosis or have

  ever been diagnosed with low bone density or have a recent history of fractures (in order for your doctor to assess your bone health on a regular basis).

• have a personal or family history of high blood cholesterol

  or lipid levels. AURO-LETROZOLE may increase lipid levels.

• have or have had cardiovascular or heart disease including

  any of the following: heart attack, stroke or uncontrolled blood pressure. AURO-LETROZOLE may increase the risk of cardiovascular or heart diseases.

• have pain in bones, or joints or muscles.

Driving a vehicle or using machinery:

AURO-LETROZOLE tablets are unlikely to affect your ability to drive a car or to use machinery. However, some patients may occasionally feel tired, dizzy, sleepy or experience visual disorders. If this happens, you should not drive or operate any tools or machinery until you feel normal again.

INTERACTIONS WITH THIS MEDICATION

Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with AURO-LETROZOLE.

PROPER USE OF THIS MEDICATION

Usual dose:

The usual dosage is one tablet of AURO-LETROZOLE to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take AURO-LETROZOLE with or without food. It is best to take AURO-LETROZOLE at about the same time every day.

Overdose:

If overdosage is known or suspected, contact your doctor or the nearest poison control centre for advice immediately. Show the pack of tablets. Medical treatment may be necessary.

Missed Dose:

If you forget to take a dose of AURO-LETROZOLE, don't worry, take the missed dose as soon as you remember. However, if it is almost time for the next dose (e.g., within 2 or 3 hours), skip the missed dose and go back to your regular dosage schedule. Do not take a double dose to make up for the one that you missed.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, AURO-LETROZOLE can have some side effects. Most side effects that have been observed were mild to moderate. Check with your doctor if the unwanted effects do not go away during treatment or become bothersome.

Some side effects, such as hot flushes, hair loss or vaginal bleeding may be due to the lack of estrogen in your body.

Very common side effects (they affect more than 10 in every 100 patients)

• hot flushes
• night sweat
• pain in bones and joints.

Common side effects (they affect between 1 to 10 in every 100 patients)

• headache
• rash
• dizziness
• generally feeling unwell
• gastrointestinal disorders (such as, nausea, vomiting, indigestion, constipation, diarrhea)
• increase in or loss of appetite
• increased blood sugar (hyperglycaemia)
• urinary incontinence
• pain in muscles
• bone loss (osteoporosis)
• bone fractures
• depression
• weight increase
• anxiety
• insomnia
• hair loss
• fatigue
• Increased sweating
• high level of cholesterol (hypercholesterolemia).

Uncommon side effects (they affect between 1 to 10 in every 1000 patients)

• nervous disorders (such as nervousness, irritability, drowsiness)

• reduced sense of touch (dysaesthesia)
• eye irritation
• palpitations, rapid heart rate
• raised blood pressure (hypertension)

• dry skin, itchy rash (urticaria), rapid swelling of face,

  lips, tongue, throat (angioedema)

• severe allergic reaction (anaphylactic reaction)

• vaginal disorders (such as bleeding, discharge or

  dryness)

• abdominal pain
• joint stiffness (arthritis)
• breast pain
• fever
• thirst, taste disorder, dry mouth
• dryness of mucous membranes
• weight decrease
• urinary tract infection, increased frequency of urination
• cough

• abnormal liver function test results (blood test

  disorders).

If you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking AURO-LETROZOLE, contact your doctor or pharmacist.

HOW TO STORE IT

Store your tablets in a dry place at room temperature 15 to 30 °C. Avoid places where the temperature may rise above 30°C. Protect from moisture.

Keep this medicine out of the reach and sight of children and pets.

Expiry date:

Do not take AURO-LETROZOLE after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Remember to take any unused medication back to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

……………………………………………………………….

• Report online: www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701C Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402 Woodbridge, ON, L4L 8K8 CANADA

Call toll-free at 1-855-648-6681 www.auropharma.ca

Date of Preparation: May 08, 2013