Details for: FEMARA 2.5MG
Company: NOVARTIS PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02231384 | FEMARA 2.5MG | LETROZOLE | 2.5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication 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 it does
Estrogen is a normally occurring female sex hormone that stimulates normal breast tissue and the growth of some types of breast cancer. FEMARA 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
FEMARA 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 FEMARA 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 FEMARA beyond the
standard 5 years of hormone therapy is called "extended adjuvant
therapy"
When it should not be used
FEMARA should not be used in children and adolescents under 18 years of age.
FEMARA should not be used in hormone-receptor negative disease.
Do not take FEMARA if you:
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in FEMARA;
- still have menstrual periods;
- are pregnant or breast-feeding, as FEMARA may harm your baby.
What the medicinal ingredient is
Letrozole
What the non-medicinal ingredients are
FEMARA also contains the following non-medicinal ingredients needed to make the tablets: cellulose compounds (microcrystalline cellulose and methylhydroxypropylcellulose), corn starch, iron oxide, lactose, magnesium stearate, polyethylene glycol, sodium starch glycolate, silicon dioxide, talc and titanium dioxide.
What dosage form it comes in
FEMARA (letrozole) 2.5 mg tablets
FEMARA is supplied as film-coated tablets. The film-coated tablets are dark-yellow and round with bevelled edges. They are marked with “FV” on one side and “CG” on the other.
FEMARA is supplied in blister packs containing 30 tablets.
Warnings and precautions
Serious Warnings and Precautions
FEMARA should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.
FEMARA 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 FEMARA, 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 FEMARA 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 FEMARA 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.
FEMARA should not be used in children and adolescents under 18 years of age.
Before you take FEMARA:
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. FEMARA may increase lipid levels;
- have or have had cardiovascular or heart disease including any of the following: heart attack, stroke or uncontrolled blood pressure. FEMARA may increase the risk of cardiovascular or heart diseases;
- have an intolerance to milk sugar (lactose);
- have pain in bones, or joints or muscles.
Your level of hormones may be checked by your doctor before you take FEMARA and regularly during the first 6 months of treatment to confirm your menopausal status (cessation of periods)
Driving a vehicle or using machinery:
FEMARA 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 FEMARA. This includes in particular:
- Tamoxifen.
- Other anti-estrogens or estrogen-containing therapies.
These substances may diminish the action of FEMARA.
Proper use of this medication
Usual dose
The usual dosage is one tablet of FEMARA to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take FEMARA with or without food. It is best to take FEMARA at about the same time every day.
Overdose
Missed Dose
If you forget to take a dose of FEMARA, 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 FEMARA 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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| -Pain in the 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 (signs of brain disease e.g. stroke); | ✔ | ||
| Swelling and redness along a vein which is extremely tender and possibly painful when touched (signs of 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); | ✔ | ||
| Swelling mainly of the face and throat (signs of allergic reaction); | ✔ | ||
| 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 FEMARA, contact your doctor or pharmacist.
How to store
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 FEMARA 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 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 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, Ontario
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 side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
www.novartis.ca
or by contacting the sponsor, Novartis Pharmaceuticals Canada Inc, at:
1-800-363-8883
This leaflet was prepared by Novartis Pharmaceuticals Canada Inc.
Last revised: July 20, 2017
FEMARA is a registered trademark.