Patient Medication Information: uses, side effects, how to take - Letrozole Tablets
ABOUT THIS MEDICATION
What Letrozole Tablets are 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 Letrozole Tablets do:
Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. Letrozole Tablets are 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 Letrozole Tablets 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 Letrozole Tablets 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 Letrozole Tablets beyond the standard 5 years of hormone therapy is called "extended adjuvant therapy".
When it should not be used:
Letrozole Tablets should not be used in children and adolescents under 18 years of age.
Letrozole Tablets should not be used in hormone-receptor negative disease.
Do not take Letrozole Tablets if you:
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in Letrozole Tablets;
- still have menstrual periods;
are pregnant or breast-feeding, as Letrozole
Tablets may harm your baby.
What the medicinal ingredient is:
Letrozole
What the nonmedicinal ingredients are: Letrozole Tablets also contain the following
non-medicinal ingredients needed to make the tablets: lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, titanium dioxide, iron oxide yellow and polyethylene glycol.
What dosage forms it comes in:
Letrozole Tablets 2.5 mg
Yellow circular, biconvex film coated tablets, debossing with ‘DB03’ on one side and plain on the other side.
Letrozole Tablets are supplied in blister packages. Each carton contains two blister packages of 14 tablets each.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Letrozole Tablets should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.
Letrozole Tablets 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 Letrozole Tablets, 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 Letrozole Tablets if you may become pregnant, or are pregnant. There is a potential risk of harm to you and the fetus. There are reports of spontaneous abortions and abnormalities in babies born to mothers who took letrozole during pregnancy. 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. Use effective birth control during treatment and for at least 20 days after stopping Letrozole Tablets. Ask your doctor about options of for effective birth control.
You should not use Letrozole Tablets if you are breastfeeding. There is a potential risk of harm to breastfed babies.
Letrozole Tablets may reduce fertility in males.
If there is exposure to Letrozole Tablets 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.
Letrozole Tablets should not be used in children and adolescents under 18 years of age.
Before you take Letrozole Tablets:
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. Letrozole Tablets may increase lipid levels;
- have or have had cardiovascular or heart disease including any of the following: heart attack, stroke or uncontrolled blood pressure. Letrozole Tablets 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: 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 Letrozole Tablets. This includes in particular:
- Tamoxifen
- Other anti-estrogens or estrogen-containing therapies.
These substances may diminish the action of Letrozole Tablets.
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dosage is one tablet of Letrozole Tablets to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take Letrozole Tablets with or without food. It is best to take Letrozole Tablets 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 Letrozole Tablets, 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 Letrozole Tablets 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, vertigo
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
- back pain
- fall
- palpitations (rapid heart rate)
- joint stiffness (arthritis)
- chest 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
- itchy rash (urticaria), rapid swelling of face, lips, tongue, throat (angioedema)
- severe allergic reaction (anaphylactic reaction)
- vaginal disorders (such as discharge or dryness)
- 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).
- increased bilirubin level (dark coloured urine)
- jaundice (yellowish eyes and/or skin).
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 Letrozole Tablets, contact your doctor or pharmacist.
HOW TO STORE IT
Store your tablets in a dry place at room temperature (15 °C to 30 °C), protected from light and moisture. Avoid places where the temperature may rise above 30 °C.
Keep this medicine out of the reach and sight of children and pets.
Expiry date:
Do not take Letrozole Tablets 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.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last revised: November 10, 2017
| 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 the muscles, bones and joints; -Joint stiffness; -Persistent sad mood (i.e., depression). | √ √ | √ | |||
| Uncommon | |||||
| √ √ √ √ √ √ √ √ √ √ | ||||
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.