Evista


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raloxifene

Evista

Pharmacologic class: Nonsteroidal benzothiophene derivative

Therapeutic class: Selective estrogen receptor modulator, bone resorption inhibitor

Pregnancy risk category X

Action

Binds to estrogen receptors, activating estrogen pathways and increasing bone mineral density. These effects decrease bone resorption and turnover.

Availability

Tablets: 60 mg

Indications and dosages

Treatment and prevention of osteoporosis in postmenopausal women; reduction of invasive breast cancer risk in postmenopausal women with osteoporosis; reduction of invasive breast cancer risk in postmenopausal women at high risk for invasive breast cancer

Adults: 60 mg P.O. daily

Off-label uses

• Prophylaxis of cardiovascular disease

Contraindications

• Hypersensitivity to drug or its components

• History of thromboembolic events

• Premenopausal women

• Females of childbearing age

• Pregnancy or breastfeeding

• Children

Precautions

Use cautiously in:

• altered lipid metabolism, hepatic dysfunction

• concurrent estrogen therapy (use not recommended)

• immobilized patients and others at increased risk for thromboembolic events.

Administration

• Give with or without food.

Adverse reactions

CNS: depression, insomnia, vertigo, syncope, hypoesthesia, migraine, neuralgia

CV: chest pain, peripheral edema, varicose veins, deep-vein thrombosis, thrombophlebitis

EENT: conjunctivitis, sinusitis, rhinitis, pharyngitis, laryngitis

GI: nausea, vomiting, diarrhea, abdominal pain dyspepsia, flatulence, gastroenteritis

GU: urinary tract infection or disorder, cystitis, vaginitis, leukorrhea, endometrial disorder, vaginal hemorrhage

Musculoskeletal: leg cramps, joint pain, myalgia, arthritis, tendon disorder

Respiratory: cough, pneumonia, bronchitis, pulmonary embolism

Skin: rash, diaphoresis

Other: weight gain, hot flashes, infection, pain, flulike symptoms

Interactions

Drug-drug. Cholestyramine: reduced raloxifene absorption

Highly protein-bound drugs (such as diazepam, diazoxide, lidocaine): interference with binding of these drugs

Warfarin: decreased prothrombin time

Drug-diagnostic tests. Albumin, apolipoprotein B, calcium, fibrinogen, inorganic phosphate, low-density lipoproteins, platelets, protein, total cholesterol: decreased levels

Apolipoprotein A1; corticosteroid-binding, sex steroid-binding, and thyroid-binding globulin: increased levels

Patient monitoring

Watch for thromboembolic events, especially during first 4 months of therapy.

• Stay alert for other adverse effects, particularly leg cramps, other musculoskeletal complaints, and respiratory disorders.

• Assess bone mineral density test results.

• Monitor for unexplained vaginal bleeding.

Patient teaching

• Tell patient she may take with or without food.

• Instruct patient to read package insert before starting drug and then periodically.

Teach patient to recognize and immediately report symptoms of blood clots.

• Instruct patient to stop taking drug 3 days before anticipated period of prolonged immobility, and to restart it only after she regains normal mobility.

• Tell patient that drug may cause hot flashes, but that these are normal effects.

• Advise patient to report unexplained vaginal bleeding or leg cramps.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

raloxifene

(ra-lox-i-feen) ,

Evista

(trade name)

Classification

Therapeutic: bone resorption inhibitors
Pharmacologic: selective estrogen receptor modulators
Pregnancy Category: X

Indications

Treatment and prevention of osteoporosis in postmenopausal women.Reduction of the risk of breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer.

Action

Binds to estrogen receptors, producing estrogen-like effects on bone, resulting in reduced resorption of bone and decreased bone turnover.

Therapeutic effects

Prevention of osteoporosis in patients at risk.
Decreased risk of breast cancer.

Pharmacokinetics

Absorption: Although well absorbed (>60%), after oral administration, extensive first-pass metabolism results in 2% bioavailability.
Distribution: Highly bound to plasma proteins; remainder of distribution unknown.
Protein Binding: Highly bound to plasma proteins.
Metabolism and Excretion: Extensively metabolized by the liver; undergoes enterohepatic cycling; excreted primarily in feces.
Half-life: 27.7 hr.

Time/action profile (effects on bone turnover)

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Contraindications/Precautions

Contraindicated in: Hypersensitivity;History of thromboembolic events; Obstetric / Lactation: Not indicated for women with childbearing potential or who are breast feeding; Pediatric: Safety not established.
Use Cautiously in: Potential immobilization (↑ risk of thromboembolic events);History of stroke or transient ischemic attack;Atrial fibrillation;Hypertension;Cigarette smoking.

Adverse Reactions/Side Effects

Central nervous system

  • stroke (life-threatening)

Cardiovascular

  • thromboembolism (life-threatening)

Ear, Eye, Nose, Throat

  • retinal vein thrombosis

Musculoskeletal

  • leg cramps (most frequent)

Miscellaneous

  • hot flashes (most frequent)

Interactions

Drug-Drug interaction

Cholestyramine ↓ absorption (avoid concurrent use).May alter effects of warfarin and other highly protein-bound drugs.Concurrent systemic estrogen therapy is not recommended.

Route/Dosage

Oral (Adults) 60 mg once daily.

Availability

Tablets: 60 mg Cost: $630.76 / 100

Nursing implications

Nursing assessment

  • Assess patient for bone mineral density with x-ray, serum, and urine bone turnover markers (bone-specific alkaline phosphatase, osteocalcin, and collagen breakdown products) before and periodically during therapy.
  • Lab Test Considerations: May cause ↑ apolipoprotein A-I and reduced serum total cholesterol, LDL cholesterol, fibrinogen, apolipoprotein B, and lipoprotein.
    • May cause ↑ hormone-binding globulin (sex steroid-binding globulin, thyroxine-binding globulin, corticosteroid-binding globulin) with ↑ total hormone concentrations.
    • May cause small ↓ in serum total calcium, inorganic phosphate, total protein, and albumin.
    • May also cause slight decrease in platelet count.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Do not confuse Evista (raloxifene) with Avinza (morphine sulfate, extended release).
  • Oral: May be administered without regard to meals.
    • Calcium supplementation should be added to diet if daily intake is inadequate.

Patient/Family Teaching

  • Instruct patient to take raloxifene as directed. Discuss the importance of adequate calcium and vitamin D intake or supplementation. Instruct patient to read the Medication Guide when initiating therapy and again with each prescription refill in case of changes.
  • Advise patient to discontinue smoking and alcohol consumption.
  • Emphasize the importance of regular weight-bearing exercise. Advise patient that raloxifene should be discontinued at least 72 hr before and during prolonged immobilization (recovery from surgery, prolonged bedrest). Instruct patient to avoid prolonged restrictions of movement during travel because of the increased risk of venous thrombosis.
  • Advise patient that raloxifene will not reduce hot flashes or flushes associated with estrogen deficiency and may cause hot flashes.
  • Instruct patient to notify health care professional immediately if leg pain or a feeling of warmth in the lower leg (calf); swelling of the legs, hands, or feet; sudden chest pain; shortness of breath or coughing up blood; or sudden change in vision, such as loss of vision or blurred vision occur. Being still for a long time (sitting still during a long car or airplane trip, being in bed after surgery) can increase risk of blood clots.
  • Advise patient that raloxifene may have teratogenic effects. Instruct patient to notify health care provider immediately if pregnancy is planned or suspected.

Evaluation/Desired Outcomes

  • Prevention of osteoporosis in postmenopausal women.
  • Reduced risk of breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer.

Evista

(ē-vĭs′tə)
A trademark for the drug raloxifene hydrochloride.

Evista®

Raloxifene, see there.
References in periodicals archive ?
For the most recent 12 months ending in September 2016, the Evista brand and generic had US sales of about USD265m MAT, according to IMS Health.
Raloxifene made by local enterprises came into the market after Evista entered China in Oct.
In Puerto Rico, the company manufactures pharmaceutical products such as Cymbalta, Cialis, Evista, Strattera, Symbyax, Zyprexa and engages in bulk production for Humalog, Forteo and Humatrope.
]hey are raloxifene (Evista), bisphosphonates (Actonel, Boniva, Fosamax, Reclast), parathyroid hormone, denosumab (Prolia), and calcitonin (Fortical, Miacalcin) (Level A evidence).
Raloxifene is the generic name of Eli Lilly's Evista, which also faces generic competition in Europe.
Lupus flares are rare in postmenopausal women, so this finding suggested a possible association between raloxifene (Evista) and disease activity explained Dr.
La imagen que recorrio el mundo no dejo lugar a dudas: el gobierno "evista" hace maniobras sospechosas para socavar la tambaleante democracia boliviana.
My doctor wanted me to start taking Evista (raloxifene hydrochloride) for osteoporosis, but I'm worried because the drug is linked to a risk of blood clots.
Alternative prescription therapies for osteoporosis may include Evista (tablets with estrogen-like action), Forteo (an injectable form of synthetic parathyroid hormone), and Calcitonin (a nasal spray or injectable form of a hormone involved in calcium metabolism).
But a newer drug raloxifene, sold as Evista is safer, a private news channel reported.