What is Evista (Raloxifene)? What Is It Used For?

What is Evista?

Evista is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Evista is for postmenopausal women and has multiple uses.

What Are the Possible Side Effects of Evista?

Possible side effects of Evista include:

  • abdominal pain, chest pain
  • swelling
  • breast pain
  • vaginal bleeding
  • urinary tract infections
  • sweating, cough
  • skin rash
  • dizziness
  • insomnia, depression
  • vomiting, diarrhea

WARNING

Serious and life-threatening side effects can occur while taking Evista. These include dying from blood clots and stroke:

An increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) has been reported with Evista. Women who have or have a history of blood clots in their legs, lungs, or eyes should not take Evista.

An increased risk of death from stroke occurred in a study of postmenopausal women with documented coronary heart disease or at high risk for major coronary events. Risk-benefit balance should be considered in women at risk of stroke.

What are the indications?

Evista treats and prevents osteoporosis by helping to make bones stronger and less likely to break.

If there is a high risk for osteoporosis or breast cancer, Evista can be used to reduce the chance of developing invasive breast cancer. Evista will not be able to completely avoid the possibility of developing breast cancer. The doctor can estimate the risk of breast cancer by asking questions about risk factors.

Evista is indicated for reducing the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

Usage Restrictions

Evista is not for use in premenopausal women (women who have not passed the menopause).

Once the risk of developing breast cancer has been assessed, the decision regarding treatment with Evista should be based on an individual assessment of the benefits and risks. Evista does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting Evista and should continue regular breast exams and mammograms in accordance with good medical practice after starting treatment with Evista.

No data are available regarding the effect of Evista on the incidence of invasive breast cancer in women with inherited mutations, to be able to make specific recommendations regarding the efficacy of Evista.

Evista is not indicated for the treatment of invasive breast cancer or for reducing the risk of recurrence.

Evista is not indicated for a reduced risk of noninvasive breast cancer.

What are the dosage and usage recommendations?

The recommended dose is one 60 mg Evista (raloxifene hydrochloride tablets) tablet per day and can be administered at any time of the day regardless of meals.

Suggestions for Calcium and Vitamin D Supplementation: Supplemental calcium and/or vitamin D should be added to the diet if daily intake is insufficient for the treatment or prevention of osteoporosis. Postmenopausal women need an average of 1500 mg/day of elemental calcium. Total daily calcium intake above 1500 mg did not show additional bone benefits, while daily intake above 2000 mg was associated with an increased risk of side effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400-800 IU daily. Patients at high risk of vitamin D deficiency may need additional vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

What are the Storage Conditions?

Evista should be stored at controlled room temperature between 20° – 25° C (68° – 77° F); can be found outside between 15° and 30° C (59° and 86° F).

Warnings and Precautions

Venous Thromboembolism: In clinical studies, women treated with Evista have an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events may also occur. Superficial thrombophlebitis, a less serious event, was also reported more frequently with Evista than with placebo. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of the risk appears similar to the reported risk associated with the use of hormone therapy. Evista should be discontinued at least 72 hours before and during prolonged immobilization, as immobilization increases the risk of venous thromboembolic events regardless of treatment. Additionally, women taking Evista should be advised to move periodically during extended travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease due to other causes such as congestive heart failure, superficial thrombophlebitis and active malignancy.

Death Due to Stroke: In a clinical study of postmenopausal women with documented coronary heart disease or at increased risk of coronary events, an increased risk of death from stroke was observed after treatment with Evista. Evista had no significant effect on all-cause mortality. The risk-benefit balance should be considered in women at previous stroke risk.

Cardiovascular Disease: Evista should not be used for primary or secondary prevention of cardiovascular disease. In a clinical study in postmenopausal women with documented coronary heart disease or at high risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years.

Premenopausal Use: There are no indications for premenopausal use of Evista. The safety of Evista in premenopausal women has not been established and its use is not recommended.

Concurrent Estrogen Therapy: The safety of simultaneous use of Evista with systemic estrogens has not been established and its use is not recommended.

Hypertriglyceridemia When Treated With Estrogens: Limited clinical data suggest that some women with a history of significant hypertriglyceridemia in response to treatment with oral estrogen or estrogen plus progestin may have increased triglyceride levels when treated with Evista. Women with this medical history should monitor their serum triglycerides while taking Evista.

Breast Cancer History: Evista has not been adequately studied in women with a prior history of breast cancer.

Usage in Men: There is no indication of the use of Evista in men. Evista has not been adequately studied in men and its use is not recommended.

Unexplained Uterine Bleeding: Any unexplained uterine bleeding should be investigated as clinically indicated. Evista-treated and placebo-treated groups had similar incidences of endometrial proliferation.

Chest Abnormalities: Unexplained breast abnormalities that occur during Evista therapy should be investigated. Evista does not eliminate the risk of breast cancer.

Inactivity: Evista should be discontinued at least 72 hours before and during prolonged immobilization and patients should be advised to avoid prolonged movement restrictions during travel due to the increased risk of venous thromboembolic events.

Hot Flashes: Evista may increase the incidence of hot flashes and is not effective in reducing hot flashes associated with estrogen deficiency. In some asymptomatic patients, hot flashes may occur at the beginning of Evista therapy.

Reduction in Invasive Breast Cancer Risk in Postmenopausal Women with Osteoporosis or at High Risk of Invasive Breast Cancer: Evista use is associated with a reduced risk of invasive breast cancer in postmenopausal women. Evista has not been shown to reduce the risk of noninvasive breast cancer. When evaluating treatment, physicians should discuss the potential benefits and risks of Evista therapy with the patient. Evista is not indicated for the treatment of invasive breast cancer or for reducing the risk of recurrence. Patients should have breast exams and mammograms before starting Evista and should continue regular breast exams and mammograms in accordance with good medical practice after starting treatment with Evista.

Pregnancy: Evista should not be used in women who are or may become pregnant.

Breastfeeding Period: Evista should not be used by women who are breastfeeding. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when raloxifene is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No overall differences in safety or efficacy were observed between this population and the younger population, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals cannot be excluded. Based on clinical studies, no dose adjustment is required for geriatric patients.

Kidney failure: Evista should be used with caution in patients with moderate or severe renal impairment.

Liver failure: Evista should be used with caution in patients with hepatic impairment.

What should be done in case of overdose?

In post-marketing spontaneous reports, raloxifene overdose has been reported very rarely. The highest overdose was approximately 1.5 grams. No deaths associated with raloxifene overdose have been reported. Adverse reactions, including leg cramps and dizziness, were reported in half of patients receiving 180 mg or less of raloxifene. There is no specific antidote for raloxifene.

What are the contraindications?

Evista is contraindicated in women with thromboembolism (VTE), deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Evista is contraindicated in pregnancy, women who may become pregnant, and nursing mothers. Evista may cause fetal harm when administered to a pregnant woman. If this medicine is used during pregnancy or if the patient becomes pregnant while taking this medicine, the patient should be made aware of the potential danger to the fetus.

Movement Mechanism

Raloxifene is an estrogen agonist/antagonist, often referred to as a selective estrogen receptor modulator (SERM). The biological effects of raloxifene are mediated largely by binding to estrogen receptors. This binding results in activation (agonism) of estrogenic pathways in some tissues and blockade (antagonism) of estrogenic pathways in others. The agonistic or antagonistic action of raloxifene is dependent on the extent to which coactivators and corepressors are recruited to estrogen receptor (ER) target gene promoters. Raloxifene appears to act as an estrogen agonist in bone. It reduces bone resorption and bone turnover, increases bone mineral density (BMD) and reduces the incidence of fractures. Preclinical data indicate that raloxifene is an estrogen antagonist in uterine and breast tissues. These results are consistent with findings from clinical studies showing that Evista does not have estrogen-like effects on uterine and breast tissue.

Raloxifene is rapidly absorbed after oral administration. About 60% of an oral dose is absorbed, but presystemic glucuronide conjugation is common. The absolute bioavailability of raloxifene is 2%. Time to reach mean maximum plasma concentration and bioavailability are functions of the enterohepatic cycle and systemic conversion of raloxifene and its glucuronide metabolites. Evista can be applied regardless of meals.

Following intravenous administration, raloxifene is cleared at a rate approaching hepatic blood flow. Raloxifene and its glucuronide conjugates are interconverted by reversible systemic metabolism and enterohepatic cycling, thus prolonging the plasma elimination half-life to 27.7 hours after oral dosing. Raloxifene is mainly excreted in the faeces and less than 0.2% is excreted unchanged in the urine. Less than 6% of a raloxifene dose is excreted in the urine as glucuronide conjugates.

Required Information for Safe and Effective Use

Medications are sometimes prescribed for purposes other than those listed in the medication guide. Evista should not be used for a condition for which it was not prescribed and should not be given to others, even if they have the same symptoms. Before starting Evista, the doctor should be told if you have blood clots in the legs, lungs, or eyes, stroke, mini-stroke (transient ischemic attack), or irregular heartbeat. Taking Evista should be discontinued and a doctor should be sought. Being sedentary for long periods of time can increase the risk of blood clots.

Source: Evista (Raloxifene) Drug, 2020

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