Raloxifene hydrochloride

What is Raloxifene hydrochloride?

• Raloxifene hydrochloride (Evista) is an estrogen agonist/antagonist used to reduce the risk of invasive breast cancer in postmenopausal women who are at high risk of the disease or who have osteoporosis.
• It is also used to prevent and treat osteoporosis in postmenopausal women.
• Raloxifene hydrochloride is also being studied in the treatment of other types of cancer.

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Raloxifene

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Raloxifene Chemical Structure V 3

What are the uses of this medicine?

Raloxifene hydrochloride (Evista) is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Evista is for women after menopause, and has more than one use:

• Osteoporosis: Evista treats and prevents osteoporosis by helping make your bones stronger and less likely to break.

• Invasive Breast Cancer: If you have osteoporosis or are at high risk for breast cancer, Evista can be used to lower your chance of getting invasive breast cancer. Evista will not totally get rid of your chance of getting breast cancer. Your doctor can estimate your risk of breast cancer by asking you about risk factors, including:

• your age (getting older).
• family history of breast cancer in your mother, sister, or daughter.
• a history of any breast biopsy, especially an abnormal biopsy.

Limitations of use:

• Evista is not for use in premenopausal women (women who have not passed menopause).
• Evista is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer.

How does this medicine work?

• Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM).
• The biological actions of raloxifene are largely mediated through binding to estrogen receptors.
• It blocks the effects of the hormone estrogen in breast tissue, which may help keep breast cancer cells from growing.
• It may also help keep bone from breaking down.
• Raloxifene appears to act as an estrogen agonist in bone.
• It decreases bone resorption and bone turnover, increases bone mineral density (BMD) and decreases fracture incidence.
• In several large clinical trials, raloxifene was shown to increase bone mineral density and prevent bone fractures in postmenopausal women at high risk for osteoporosis, while decreasing serum cholesterol levels (both total and LDL) and without stimulating breast and uterine growth.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have or have had blood clots in your legs, lungs, or eyes.
• are pregnant or could become pregnant.
• are nursing a baby.

What drug interactions can this medicine cause?

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

Especially tell your doctor if you take*:

• warfarin (Coumadin®, Jantoven®)
• If you are taking warfarin or other coumarin blood thinners, your doctor may need to do a blood test when you first start or if you need to stop taking Evista. Names for this test include “prothrombin time,” “pro-time,” or “INR.” Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinner.
• cholestyramine
• estrogens
• Evista should not be taken with cholestyramine or estrogens.

Is this medicine FDA approved?

• Raloxifene was approved for medical use in the United States in 1997.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is one 60 mg Evista (raloxifene hydrochloride tablets) tablet daily, which may be administered any time of day without regard to meals.
• For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
• Postmenopausal women require an average of 1500 mg/day of elemental calcium.
• The recommended intake of vitamin D is 400-800 IU daily.

Administration:

• Keep taking Evista for as long as your doctor prescribes it for you. It is not known how long you should keep taking Evista to lower your chance of getting invasive breast cancers.
• It is important to get your refills on time so you do not run out of the medicine.
• Take one Evista tablet each day.
• Take Evista at any time of the day, with or without food.
• To help you remember to take Evista, it may be best to take it at about the same time each day.
• Calcium and vitamin D may be taken at the same time as Evista. It is important to take calcium and vitamin D, as directed by your physician, to prevent or treat osteoporosis.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take two doses at the same time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets (not scored): 60 mg

This medicine is available in fallowing brand namesː

• Evista

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flashes, leg cramps, swelling of the feet, ankles, and legs, flu syndrome, joint pain, and sweating

Serious and life-threatening side effects can occur while taking Evista which may include:

• deep vein thrombosis
• pulmonary embolism
• dying from stroke

What special precautions should I follow?

• Increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. Discontinue use 72 hours prior to and during prolonged immobilization.
• Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. No increased risk of stroke was seen in this trial. Consider risk-benefit balance in women at risk for stroke.
• Evista should not be used for the primary or secondary prevention of cardiovascular disease.
• There is no indication for premenopausal use of Evista. Safety of Evista in premenopausal women has not been established and its use is not recommended.
• Evista should be used with caution in patients with hepatic impairment. Safety and efficacy have not been established in patients with hepatic impairment.
• The safety of concomitant use of Evista with systemic estrogens has not been established and its use is not recommended.
• If previous treatment with estrogen resulted in hypertriglyceridemia, monitor serum triglycerides.
• Evista should be used with caution in patients with moderate or severe renal impairment. Safety and efficacy have not been established in patients with moderate or severe renal impairment
• There is no indication for the use of Evista in men. Evista has not been adequately studied in men and its use is not recommended.
• Any unexplained breast abnormality occurring during Evista therapy should be investigated. Evista does not eliminate the risk of breast cancer.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leg cramps
• dizziness
• ataxia
• vomiting
• rash
• diarrhea
• tremor
• flushing
• elevation in alkaline phosphatase

Management of overdosage:

• There is no specific antidote for raloxifene.
• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Evista should not be used in women who are or may become pregnant.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• raloxifene hydrochloride

Inactive Ingredients:

• anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.

Who manufactures and distributes this medicine?

• Eli Lilly and Company, Indianapolis, IN , USA

What should I know about storage and disposal of this medication?

• Store at controlled room temperature, 20º to 25ºC (68º to 77ºF).

• Dailymed label info on Raloxifene hydrochloride
• FDA Raloxifene hydrochloride

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