CCP-Letrozole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What CCP-Letrozole is used for:

• The adjuvant treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer;
• The extended adjuvant treatment of hormone receptor positive invasive 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 after relapse or disease progression in women with natural or artificially-induced postmenopausal endocrine status, who have previously been treated with antiestrogens.

What does CCP-Letrozole do:

Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. CCP-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 CCP-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 CCP-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 CCP-Letrozole beyond the standard 5 years of hormone therapy is called "extended adjuvant therapy".

When it should not be used:

CCP-Letrozole should not be used in children and adolescents under 18 years of age.

CCP-Letrozole should not be used in hormonereceptor negative disease.

Do not take CCP-Letrozole if you:

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

• are pregnant or breast-feeding, as CCP-Letrozole may harm your baby.

What the medicinal ingredient is:

Letrozole

What the nonmedicinal ingredients are:

CCP-Letrozole also contains the following non-medicinal ingredients needed to make the tablets: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (contains: hypromellose, titanium dioxide, ferric oxide yellow, polyethylene glycol 8000 and talc)

What dosage forms it comes in:

CCP-Letrozole (letrozole) 2.5 mg tablets

CCP-Letrozole is supplied as yellow coloured, round shaped, shallow concave film-coated tablets having 6 mm diameter debossed with “N” on one side and “L” on other side.

CCP-Letrozole is supplied in blister pack containing 30 tablets and Bottle packs containing 30, 100 tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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

CCP-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 CCP-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 CCP-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 CCP-Letrozole during pregnancy, you should contact your doctor immediately to discuss the potential of harm to your fetus and potential risk for loss of pregnancy years of age.

Before you take CCP-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. CCP-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. CCP-Letrozole may increase the risk of cardiovascular or heart diseases;
• have an intolerance to milk sugar (lactose); have pain in bones, or joints or muscles.

Driving a vehicle or using machinery:

CCP-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 CCP-Letrozole. This includes in particular:

• Tamoxifen
• Other anti-estrogens or estrogens-containing therapies.

These substances may diminish the action of CCP-Letrozole.

PROPER USE OF THIS MEDICATION

Usual Dose:

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

Missed Dose:

If you forget to take a dose of CCP-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

As with all medicines, patients taking CCP-Letrozole may experience side effects. Most side effects that have been observed were mild to moderate and will generally disappear after a few days to a few weeks of treatment. 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)

• increased level of cholesterol (hypercholesterolemia)

• hot flushes

  • increased sweating
  • night sweats
  • fatigue (including weakness and malaise (generally feeling unwell))
  • pain in bones and joints (arthralgia).

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

• headache
• rash
• dizziness
• 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
• vaginal bleeding
• dry skin
• raised blood pressure (hypertension) abdominal pain

Uncommon side effect (they affect between 1 to 10 in every

1000 patients

• nervous disorders (such as nervousness, irritability, drowsiness)
• pain or burning sensation in hands or wrists (carpal tunnel syndrome)
• reduced sense of touch (dysaesthesia)
• eye irritation
• palpitations, rapid heart rate
• itchy rash (urticarial), rapid swelling of face, lips, tongue throuat (angiodema)
• severe allergic reaction (anaphylactic reaction)
• vaginal disorders (such as discharge or dryness)
• 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)

Side effects with frequency not known

• trigger finger, a condition in which your finger or thumb catches in a bent position

If any of these affects you severely, tell your doctor.

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 CCP-Letrozole, contact your doctor or pharmacist.

If you think you have taken too much CCP-Letrozole, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

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.

Do not take CCP-Letrozole after the expiry date. The expiry date refers to the last day of the month. Remember to take any unused medication back to your pharmacist.

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other health care professional.

This leaflet plus the full product monograph, prepared for healthcare professionals, can be obtained by contacting CellChem Pharmaceuticals Inc. by:

Phone: 613-216-1277

Last Revised: June 19, 2017

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhpmps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.