Evista

Generic and Brand Names

Evista is the brand name for the generic medication raloxifene hydrochloride. It belongs to a class of drugs known as selective estrogen receptor modulators (SERMs).

Indications for Use

Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women. It is also indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis or those at high risk for invasive breast cancer.

Dosage Forms and Strengths

Evista is available in tablet form. Each tablet contains 60 mg of raloxifene hydrochloride.

Recommended Dosage

The recommended dosage of Evista is one 60 mg tablet taken orally once a day, with or without food.

Administration Instructions

Patients should swallow tablets whole and should not crush, chew, or divide them. It can be administered at any time of the day without regard to meals.

Mechanism of Action

Evista mimics the effects of estrogen on bone tissue, helping to reduce resorption of bone and increase bone mineral density (BMD) without stimulating the breast or uterine tissues like estrogen would.

Pharmacodynamics

Raloxifene binds to estrogen receptors and acts as an estrogen agonist on bone tissue and metabolism, while functioning as an antagonist on breast and uterine tissues.

Pharmacokinetics

After oral administration, raloxifene is absorbed rapidly and undergoes extensive first-pass metabolism. The bioavailability is approximately 2%. Peak plasma concentrations occur within 1 hour of dosing. The drug is extensively bound to plasma proteins (>95%), and steady-state concentrations are achieved within 28 days.

Drug Interactions

Cholestyramine may reduce the absorption and enterohepatic cycling of raloxifene, leading to decreased plasma concentrations. Concomitant use with systemic estrogens is not recommended. Caution is advised when Evista is coadministered with warfarin or other coumarin derivatives, lipid-lowering agents, and other highly protein-bound drugs.

Contraindications

Evista is contraindicated in patients with a history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. It is also contraindicated in patients with known hypersensitivity to raloxifene or any of its excipients, and in those who are pregnant, nursing, or may become pregnant.

Precautions

Patients should be advised of the increased risk of venous thromboembolism, and that they should seek immediate care if symptoms of deep vein thrombosis or pulmonary embolism occur. Prolonged immobilization may increase this risk, and caution should be used during prolonged travel where mobility is restricted.

Adverse Reactions

The most common adverse reactions reported with Evista include hot flashes, peripheral edema, arthralgia, and flu-like symptoms. Evista can also cause leg cramps and dyspepsia.

Use in Specific Populations

Postmenopausal women are the specific population for which Evista has been approved. Safety and efficacy in premenopausal women, men, and pediatric populations have not been established.

Monitoring and Laboratory Tests

Baseline and subsequent bone mineral density assessments are recommended to monitor the drug’s effectiveness. Monitoring for signs and symptoms of venous thromboembolism is advised. Liver function tests should be performed if liver dysfunction is suspected.

Overdosage Management

In the event of an overdose, supportive care is recommended, with treatment of symptomatic hypotension if it occurs. There is no specific antidote for raloxifene overdose, and raloxifene is not easily dialyzable due to high protein binding.

Storage and Handling

Evista should be stored at room temperature, between 15°C and 30°C (59°F and 86°F). Keep the medication in its original container and protect from moisture and humidity. Keep out of reach of children.

Patient Counseling Information

Patients should be informed about the potential benefits and risks associated with Evista use, the importance of adherence to prescribed treatments, and the need for proper intake of calcium and vitamin D. They should also be educated on lifestyle factors that contribute to bone health, including weight-bearing exercise and minimizing alcohol and tobacco use.