Generic name: raloxifene (ra LOX i feen)
Brand name: Evista
Dosage forms: oral tablet (60 mg)
Drug class: Hormones / antineoplastics, Selective estrogen receptor modulators
Raloxifene is used to treat osteoporosis in postmenopausal women.
Raloxifene is not for use in men.
Raloxifene may also be used for purposes not listed in this medication guide.
Warnings
raloxifene may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.
Raloxifene can also increase your risk of a stroke, which can be fatal. This risk is highest if you have certain risk factors (such as smoking, having heart problems or high blood pressure, or if you have ever had a heart attack or a stroke).
Although this medicine is for use only in postmenopausal women, you should not take raloxifene if you are pregnant or breastfeeding.
Before taking this medicine
This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.
This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.
Do not breastfeed while taking raloxifene.
Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:
- heart problems, irregular heartbeats;
- a heart attack or stroke, including "mini-stroke";
- high blood pressure;
- cancer; or
- if you smoke.
Tell your doctor if you have ever had:
- a blood clot;
- high triglycerides caused by using estrogen;
- liver or kidney disease;
- endometriosis;
- abnormal vaginal bleeding; or
- if you have not gone through menopause.
How should I take raloxifene?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take the medicine at the same time each day, with or without food.
If you need major surgery or will be on long-term bed rest, you will need to stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take raloxifene.
Raloxifene is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor's instructions very closely.
Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking raloxifene?
If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.
Avoid sitting still for long periods of time during travel while you are taking raloxifene.
Raloxifene side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using raloxifene and call your doctor at once if you have:
- swelling, tenderness, or other changes in your breasts;
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;
- signs of a blood clot in the lung--chest pain, trouble breathing, coughing up blood; or
- signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.
Common side effects may include:
- hot flashes;
- leg cramps;
- swelling in your hands, feet, or ankles;
- joint pain;
- flu symptoms; or
- increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Raloxifene dosing information
Usual Adult Dose for Osteoporosis:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Osteoporosis:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Breast Cancer:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
What other drugs will affect raloxifene?
Tell your doctor about all your other medicines, especially:
- cholestyramine;
- warfarin (Coumadin, Jantoven); or
- birth control pills or hormone replacement therapy.
This list is not complete. Other drugs may affect raloxifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.