Health Centres - Evista (raloxifene)
How does it work?
Evista tablets contain the active ingredient raloxifene hydrochloride, which is a type of medicine called a selective oestrogen receptor modulator (SERM).
Oestrogen, the main female sex hormone, has many actions throughout the body. Bone tissue, cholesterol metabolism, breast tissue and uterine tissue are all affected by this hormone. At the menopause, blood levels of oestrogen start to decrease and this affects the tissues that are normally responsive to oestrogen.
In terms of bone tissue, declining levels of oestrogen result in an increase in bone breakdown, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones are weak and break more easily.
Raloxifene is used to both prevent and treat osteoporosis in postmenopausal women. It works by acting on oestrogen receptors in the bone tissue, where it mimicks the natural effects of oestrogen. This gradually reverses the excessive breakdown of bone that happens at menopause and causes an increase in bone mineral density, making bones stronger. Raloxifene has been shown to significantly reduce the risk of spinal fractures, but not hip fractures.
Raloxifene selectively mimicks the effects of oestrogen on bone tissue, but does not affect breast tissue or uterine tissue. This means that long-term use does not carry the increased risk of cancer of the lining of the womb (endometrial cancer) or breast cancer that is associated with long-term use of oestrogen-based hormone replacement therapy (HRT). However, raloxifene is associated with an increased risk of developing blood clots in the veins (venous thromboembolism). This risk is similar to that associated with hormone replacement therapy (HRT).
Due to its selective activity, raloxifene is not effective at relieving other symptoms of oestrogen deficiency that occur during the menopause, for example hot flushes.
What is it used for?
- Prevention and treatment of osteoporosis in women who have passed the menopause.
Warning!
- The risk of blood clots forming in the veins (thromboembolism) while taking this medicine may be temporarily increased if you have surgery, or experience major trauma or other illnesses or conditions that cause you to be immobile for prolonged periods of time. If you suffer an illness or condition that results in you becoming immobile for a prolonged time, you should stop taking this medicine as soon as possible and not start taking it again until you are moving around fully. If you know in advance that you will be immobile for some time, for example due to planned surgery, then your doctor will usually ask you to stop taking this medicine three days beforehand and not to restart it until you are fully mobile again. Discuss this with your doctor.
- If you experience any vaginal bleeding while taking this medicine you should consult your doctor so this can be investigated.
Use with caution in
- Women at risk of developing blood clots in the veins (eg deep vein thrombosis or pulmonary embolism) for example due to a family history of blood clots, smoking, obesity, or blood disorders such as antiphospholipid syndrome or factor V Leiden.
- Women with a history or risk of stroke or mini-stroke (transient ischaemic attack).
- Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation).
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Breast cancer (the manufacturer recommends that this medicine should not be used until any treatment for breast cancer is finished).
- Women who have had raised levels of a type of fat called triglycerides in their blood (hypertriglyceridaemia) as a result of taking an oral oestrogen-based medicine (eg the contraceptive pill or HRT). (If this applies to you, your blood triglyceride levels should be monitored while you are taking this medicine.)
Not to be used in
- Women with a blood clot in a vein, eg blood clot in a vein of the leg (deep vein thrombosis), in the lungs (pulmonary embolism), or in the eye (retinal vein thrombosis), or a history of these conditions.
- Women with signs or symptoms of cancer of the lining of the womb.
- Severely decreased kidney function.
- Decreased liver function.
- Failure of the normal flow of bile from the liver to the intestines (cholestasis)which can result in jaundice.
- Vaginal bleeding of unknown cause.
- Pregnancy.
- Women who could get pregnant (a woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50).
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Breastfeeding.
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption (Evista tablets contain lactose).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine must not be used during pregnancy, or by women who could get pregnant, as it may be harmful to a developing foetus. (A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. If you fall into this group, you should make sure you use adequate methods of contraception to prevent pregnancy while taking this medicine.) Consult your doctor immediately if you get pregnant during treatment.
- It is not known if this medicine passes into breast milk. It should not be used by breastfeeding women, because of the potential harm it may cause to nursing infants. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Hot flushes
- Flu-like symptoms
- Leg cramps
- Swelling of the legs and ankles due to excess fluid retention (peripheral oedema)
- Blood clots in the veins (eg, DVT, pulmonary embolism, retinal vein thrombosis - see warnings above)
- Decreased numbers of platelets in the blood
- Abdominal pain
- Indigestion (dyspepsia)
- Nausea and vomiting
- Migraine
- Headache
- Rash
- Rise in blood pressure
- Breast pain, englargement or tenderness
- Blood clot in an artery (eg stroke)
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
