Dosage and Administration
Evista is supplied in a tablet dosage form of 60mg for oral administration.
Recommended Dosing
The recommended dosage is one 60 mg EVISTA tablet daily, which may be administered any time of day without regard to meals.
For the indications in risk of invasive breast cancer the optimum duration of treatment is not known.
Recommendations for Calcium and Vitamin D Supplementation
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. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400-800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Drug Description
Evista (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:
The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.
Side Effects
If you experience any of the following serious side effects, stop taking Evista and seek emergency medical attention or notify your doctor:
- an allergic reaction
- swelling of the legs
- sudden chest pain
- coughing up blood
- changes in vision
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or is especially bothersome.
Get emergency medical help if you have any of these signs of an allergic reaction such as hives, difficulty in breathing, sudden numbness or weakness, headache, fever and flu symptoms.
Precautions
- Avoid drinking milk or eating dairy products within 2 hours after taking etidronate. Also avoid taking supplements that contain calcium, magnesium, iron, or aluminum (such as in multivitamins with iron, and in many types of antacids).
- Do not take etidronate if you have a condition called osteomalacia (softening of the bones).
- Before taking etidronate, tell your doctor if you have:
- diarrhea;
- a bone fracture;
- a stomach or esophageal ulcer or disease; or
- Kidney disease.
- If you have any of these conditions, you may not be able to use etidronate, or you may need a dosage adjustment or special tests during treatment.
- Some people using medicines similar to etidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
- You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
- FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
- It is not known whether etidronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Drug Interactions
Before taking etidronate, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin). You may not be able to use etidronate, or you may need dosage adjustments or special tests during treatment.
There may be other drugs that can affect etidronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
