BMA Concise Guide to Medicine & Drugs

Raloxifene

Brand name Evista

Used in the following combined preparations None

QUICK REFERENCE

Drug group Drug for bone disorders

Overdose danger rating Low

Dependence rating Low

Prescription needed Yes

Available as generic No

GENERAL INFORMATION

Raloxifene is a non-steroidal anti-oestrogen drug (oestrogen is a naturally occurring female sex hormone) that is related to clomifene and tamoxifen. It is prescribed to prevent vertebral fractures in postmenopausal women who are at increased risk of osteoporosis. There is some evidence that the drug would also be useful for preventing fractures of the hip, but its use in the prevention of other bone fractures is uncertain.

Raloxifene has no beneficial effect on other menopausal problems such as hot flushes. It is not prescribed to women who might become pregnant because it may harm the unborn baby, and it is not prescribed to men.

There is an increased risk of a thrombosis (blood clot) developing in a vein in the leg, but the risk is similar to that due to HRT. However, because of this risk, raloxifene is usually stopped if the woman taking it becomes immobile or bedbound, when clots are more likely to form. Treatment is restarted when full activity is resumed.

INFORMATION FOR USERS

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Tablets.

Frequency and timing of doses Once daily.

Adult dosage range 60mg daily.

Onset of effect 1–4 hours.

Duration of action 24–48 hours.

Diet advice Calcium supplements are recommended if dietary calcium is low.

Storage Keep in original container at room temperature out of the reach of children. Protect from light.

Missed dose Take as soon as you remember. If your next dose is due within 8 hours, take a single dose now and skip the next.

Stopping the drug Do not stop the drug without consulting your doctor except under conditions specified in advance, such as immobility, which increases the risk of blood clots forming.

Exceeding the dose An occasional unintentional extra dose is unlikely to be a cause for concern. But if you notice any unusual symptoms, or if a large overdose has been taken, notify your doctor.

POSSIBLE ADVERSE EFFECTS

Hot flushes, leg cramps, swollen ankles or feet, and flu-like symptoms are common adverse effects. Headaches are less common. Discuss with your doctor if you have headaches or if any of the common adverse effects are severe. If you develop a rash, you should stop taking the drug and contact your doctor. If you develop pain, tenderness, swelling, discoloration, or ulceration of the leg, these may be indications of a thrombosis (blood clot) in a vein in the leg. If any such symptoms develop, stop taking the drug and seek immediate medical attention. If a clot occurs elsewhere in the body, there may not be any obvious symptoms.

INTERACTIONS

Anticoagulants Raloxifene reduces the effect of warfarin and acenocoumarol (nicoumalone).

Colestyramine This drug reduces the absorption of raloxifene by the body.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You have had a blood clot in a vein or a pulmonary embolism.

· You have vaginal bleeding.

· You have liver or kidney problems.

· You are taking other medicines.

Pregnancy Not prescribed to premenopausal women.

Breast-feeding Not prescribed to premenopausal women.

Infants and children Not prescribed.

Over 60 No special problems.

Driving and hazardous work No special problems.

Alcohol No special problems.

PROLONGED USE

Raloxifene is normally used long term. It reduces the risk of some types of breast cancer but this benefit has to be weighed against the increased risk of stroke and venous thrombosis.

Monitoring Liver function tests may be performed periodically.