Patient Medication Information: uses, side effects, how to take - MYL-Letrozole
ABOUT THIS MEDICATION
What MYL-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 MYL-LETROZOLE do:
Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. MYL-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 MYL-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 MYL-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 MYL-LETROZOLE beyond the standard 5 years of hormone therapy is called "extended adjuvant therapy".
When it should not be used:
MYL-LETROZOLE should not be used in children and adolescents under 18 years of age.
MYL-LETROZOLE should not be used in hormone-receptor negative disease.
Do not take Myl-Letrozole if you:
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in MYL-LETROZOLE;
- still have menstrual periods;
are pregnant or breast-feeding, as MYL-LETROZOLE may harm your baby.
What the medicinal ingredient is:
Letrozole
What the nonmedicinal ingredients are:
Myl-letrozole also contains 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:
Myl-Letrozole (letrozole) 2.5 mg tablets
Myl-Letrozole is supplied as yellow, round, film-coated tablets with debossed one side with “N” and other side “L”.
Myl-Letrozole is supplied in HDBE bottles of 30’s and blister packs containing 3x10 tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Myl-Letrozole should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.
| IMPORTANT: PLEASE READ |
Myl-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 Myl-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 Myl-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 Myl-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.
Myl-Letrozole should not be used in children and adolescents under 18 years of age.
Before you take Myl-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. Myl-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. Myl-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:
Myl-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 Myl-Letrozole. This includes in particular:
- Tamoxifen
- Other anti-estrogens or estrogen-containing therapies
These substances may diminish the action of Myl-Letrozole
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dosage is one tablet of Myl-Letrozole to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take Myl-Letrozole with or without food. It is best to take Myl-Letrozole at about the same time every day.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a dose of Myl-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 Myl-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.
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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 (arthralgis).
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
- vaginal bleeding
- dry skin
- raised blood pressure (hypertension)
- abdominal pain
•
Uncommon side effects (they affect between 1 to 10 in every 1000 patients)
nervous disorders (such as nervousness,
irritability, drowsiness)
pain or burning sensation in the hands or wrists
(carpal tunnel syndrome)
- 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).
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Common | |||
-Pain in muscles, bones and joints; -Joint stiffness; -Persistent sad mood (i.e. depression) | √ √ | √ | |
| Uncommon | |||
-Tightness or feeling of heaviness in the chest or pain radiating from your chest to your arms or shoulders, neck, teeth or jaw, abdomen or back (signs of angina pectoris or heart attack); -Numbness or weakness in arm or leg or any part of the body, loss of coordination, vision changes, sudden headache, nausea, loss of coordination, difficulty in speaking or breathing (sign of brain disease e.g. stroke) | √ √ | √ √ | |
| -Swelling and redness along a vein which is extremely tender and possibly painful when touched (signs of | √ | √ | |
| IMPORTANT: PLEASE READ |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
inflammation of a vein due to a blood clot, e.g. thrombophlebitis), -Difficulty breathing, chest pain, fainting rapid heart rate, bluish skin discoloration (signs of blood clot formation in the lung such as pulmonary embolism), -Swelling of arms, hands, feet, ankles or other parts of the body (signs of oedema), -Swelling mainly of the face and throat (signs of allergic reaction) -Severe fever, chills or mouth ulcers due to infections (signs of low level of white blood cells). -Blurred vision (sign of cataract). -Yellow skin and eyes, nausea, loss of appetite, dark coloured urine (signs of hepatitis) -Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder) | √ √ √ √ √ √ √ | √ √ √ √ √ √ √ | |
This is not a complete list of side effects. For any unexpected effects while taking MYL-LETROZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Store your tablets in a dry place at room temperature 15°C 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 MYL-LETROZOLE after the expiry date, which is stated on the carton and bottle 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 on line at 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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guideline 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 professional The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
The full product monograph, prepared for health professionals can be found at:
www.mylan.ca
or by contacting the sponsor, Mylan Pharmaceuticals ULC at
1-800-575-1379
Mylan Pharmaceuticals ULC
Etobicoke, Ontario, M8Z 2S6