Details for: EVISTA (60MG)
Company: ELI LILLY CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02239028 | EVISTA (60MG) | RALOXIFENE HYDROCHLORIDE | 60 MG | TABLET | ORAL |
Summary Reports
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
EVISTA is used to treat or to prevent osteoporosis in
postmenopausal women.
What is Osteoporosis?
Osteoporosis is a thinning and weakening of the bones making the
bones more likely to break. It is common in women after
menopause or after removal of the ovaries because of the decrease
in estrogens. A variety of risk factors may promote osteoporosis.
These include:
- Caucasian or Asian descent
- Slender build
- Early menopause
- Smoking
- Drinking alcohol
- A diet low in calcium
- Lack of exercise
- A family history of osteoporosis
Initially osteoporosis usually does not cause any symptoms, but if left untreated may result in fractures. While most fractures are painful, fractures of the spine may not be noticed until they result in loss of height or a stooped posture. The fractures may occur as the result of normal every day activity or from minor injuries, which would ordinarily not result in broken bone.
How can osteoporosis be prevented or treated?
- Eat a balanced diet. Vitamin D and calcium are necessary for building strong bones. The requirement for vitamin D increases as you grow older. In the winter, when there is less sunlight, your skin produces less vitamin D. Discuss with your doctor the need to take vitamin D and calcium supplements.
- Do not smoke.
- Exercise. Bones need exercise to stay strong and healthy. Consult your doctor about an exercise program suitable to you.
- While diet, exercise and vitamins are essential to good health, they may not be enough to offset the effects of estrogen decline in some women’s bodies after menopause. Consequently, some people may require medications such as EVISTA to prevent or treat osteoporosis.
What it does
EVISTA is a Selective Estrogen Receptor Modulator or SERM. EVISTA is not a hormone, but it acts like estrogen in some parts of your body including the bones, but not like estrogen in other parts of the body. In the bones it promotes the building of new bone, either to prevent or treat osteoporosis.
When it should not be used
Do not take EVISTA if:
- you have not passed menopause. EVISTA is for use only by women after menopause.
- you are pregnant or could become pregnant. EVISTA could harm your unborn child.
- you are nursing a baby. It is not known if EVISTA passes into breast milk or what effect it might have on the baby.
- you have or have had blood clots in the veins that required a doctor’s treatment. This may include clots in the legs, lungs or eyes. Taking EVISTA may increase the risk of getting these blood clots.
- you are allergic to raloxifene or any of the other ingredients in EVISTA listed in the “nonmedicinal ingredients” section below.
What the medicinal ingredient is
raloxifene hydrochloride
What the non-medicinal ingredients are
anhydrous lactose, crospovidone, FD&C Blue No. 2 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polysorbate 80, povidone, macrogol 400 and titanium dioxide E171.
What dosage form it comes in
Tablet 60 mg.
Warnings and precautions
Before starting EVISTA and to get the best possible treatment, be sure to tell your doctor if you:
- are pregnant, breast feeding, still have menstrual bleeds, or have had a menstrual bleed in the last year, as EVISTA is only for postmenopausal women.
- have had an allergic reaction to any medicine you have taken.
- are intolerant to lactose because EVISTA contains lactose.
- have or ever had liver problems.
- have or ever had blood clots in the veins. If you take warfarin (blood thinner) or other coumarin derivatives, EVISTA may not be suitable for you. EVISTA is contraindicated in women with an active or past history of blood clots in the veins. If you are taking the blood thinners for other reasons your doctor may need to check your prothrombin (blood clotting) time and adjust your medicine when you first begin taking EVISTA.
- are currently on any other medications, prescription or non prescription.
- have had a stroke or have a history of other significant risk factors for stroke, such as a “mini-stroke” (TIA/transient ischemic attack), or a type of irregular heartbeat (atrial fibrillation).
Being immobile for a long time can increase the risk of blood clots in the veins. EVISTA may add to this risk. If while taking EVISTA you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking EVISTA at least 3 days before, to reduce your risk of blood clots in the veins. When you are back on your feet, you may start taking EVISTA again (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
Interactions with this medication
You should always tell your doctor about all drugs you are taking
or plan to take before starting to take EVISTA.
The effect of EVISTA is significantly reduced if taken with
cholestyramine (products which contain cholestyramine include
Questran®, Questran Light®, Alti-Cholestyramine Light, Novo-
Cholamine, Novo-Cholamine Light, PMS-Cholestryramine).
Therefore, you should not take cholestyramine while taking
EVISTA.
It is not recommended that you combine EVISTA with hormone
replacement therapy (ERT or HRT) since safety information is
limited and no studies have been done to look at the effectiveness
of this combination.
During clinical trials, EVISTA was taken with commonly
prescribed medications such as acetaminophen, digoxin,
nonsteroidal anti-inflammatory drugs (NSAIDS), and oral
antibiotics with no observed problems. However, because each
patient is different, you should always check with your doctor
before taking any other medication.
Proper use of this medication
Usual dose
Take one EVISTA 60 mg tablet, once-a-day, any time, with or
without food. EVISTA comes in a 28-day blister pack that you
start as soon as you fill your prescription. Each day of the week is
printed above each tablet to make it easy to check if you’ve taken
your pill that day.
You might find it helpful to take your tablet at the same time every
day so that it’s simply part of your routine. The efficacy of
EVISTA is dependent upon your taking it regularly. Therefore, you
should keep taking EVISTA until your doctor advises you
otherwise.
Overdose
If you take too much EVISTA, immediately contact your doctor or
go to your nearest hospital emergency department. Show the doctor
your blister pack of tablets. Do this even if there are no signs of
discomfort or poisoning.
For management of a suspected drug overdose, contact your
regional Poison Control Centre.
Missed Dose
If you miss a day of EVISTA take one pill as soon as you remember and resume one tablet once daily. Do not take two doses at the same time.
Side effects and what to do about them
During clinical trials, some women did have mild side effects however most women did not find these side effects serious enough to stop taking EVISTA. The most common side effects of EVISTA are:
- hot flashes
- leg cramps
Similar to estrogen replacements, EVISTA may increase the risk of blood clots in the veins. Although this is an uncommon side effect, if you experience any of the following unusual symptoms talk to your doctor immediately:
- redness, swelling, heat or pain in your calves and legs
- sudden chest pain or shortness of breath
- a sudden change in your vision
| 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 |
|---|---|---|---|
| Uncommon | |||
| Blood clots in the veins* | ✔ | ||
| Rare | |||
| Blood clots in the lungs* | ✔ | ||
| Stroke fatality** | |||
* See “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”
for symptoms of blood clots in the veins. If you experience any of
the listed symptoms talk to your doctor immediately.
** Women who have had a heart attack or are at risk for a heart
attack may have an increased risk of dying from stroke when
taking EVISTA.
This is not a complete list of side effects. For any unexpected
effects while taking EVISTA, contact your doctor or pharmacist.
How to store
All medicines should be stored out of the reach of children. EVISTA should be stored in its original package at room temperature (between 15 to 30°C) in a dry place.
Reporting side effects
To monitor drug safety, Health Canada through the
Canada Vigilance Program collects information on serious
and unexpected effects of drugs. If you suspect you have
had a serious or unexpected reaction to this drug you may
notify Canada Vigilance:
By toll-free telephone: 1-866-234-2345
By toll-free fax: 1-866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: canadavigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health products Safety and Effectiveness
Information Bureau
Marketed health Products Directorate
Health Products and Food Branch, Health Canada
Tunney’s Pasture, AL0701C
Ottawa, ON K1A 0K9
NOTE: Should you require information related to the
management of the side effect, please contact you healthcare
provider before notifying Canada Vigilance. The Canada
Vigilance program or Eli Lilly Canada Inc. do not provide
medical advice.
More information
For more information, please contact your healthcare professionals
or pharmacist first, or Eli Lilly Canada Inc. at: 1-888-545-5972, or
visit the website at www.lilly.ca.
This leaflet was prepared by Eli Lilly Canada Inc., Toronto,
Ontario, M1N 2E8.
Last revised: October 7, 2008