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raloxifene (Rx)Brand and Other Names:Evista

 
 
 

Dosing & Uses

AdultPediatric

Dosing Form & Strengths

tablet

  • 60mg

Osteoporosis in Post-menopausal Women

60 mg PO qDay

Breast Cancer

Prevention; risk reduction of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer

60 mg PO qDay for 5 years

Dosing Modifications

Moderate to severe renal impairment: Caution; safety and efficacy not established

Mild hepatic impairment: Safety and efficacy not established

Dosing Considerations

High risk of breast cancer is defined as at least 1 breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, 1 or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified Gail model)

Limitations of use for breast cancer risk reduction

  • There are no data available regarding the effect on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2), so specific recommendations on the effectiveness of raloxifene cannot be made
  • Not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence
  • Not indicated for reduction in the risk of noninvasive breast cancer

Not recommended

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Interactions

Interaction Checker

raloxifene and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hot flashes (8-29%)

            Flu syndrome (14-15%)

            Cramps/muscle spasm (6-12%)

            Arthralgia (11-16%)

            Infection (11%)

            1-10%

            Insomnia (6%)

            Vomiting (5%)

            Sinusitis (10%)

            Venous thromboembolism (1-2% )

            Bronchitis (10%)

            Pharyngitis (8%)

            Breast pain (4%)

            Gastroenteritis (<3%)

            Diaphoresis (3%)

            Frequency Not Defined

            Deep vein thrombosis

            Cerebrovascular accident

            Thrombosis of retinal vein (rare)

            Pulmonary embolism

            Decreased fibrinogen

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            Warnings

            Black Box Warnings

            Increased risk of deep vein thrombosis and pulmonary embolism has been reported with this drug

            Women with active or past history of venous thromboembolism should not take this drug

            Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events

            Consider risk-benefit balance in women at risk for stroke

            Contraindications

            Pregnancy, lactation

            Active history of thromboembolic disorders

            Women who could become pregnant

            Cautions

            Discontinue 72 hours prior to and during prolonged immobilization

            Increased risk of stroke, deep vein thrombosis/pulmonary embolism

            Supplemental calcium and vitamin D recommended

            Triglyceride levels may increase in women with history of triglyceride elevation in response to oral estrogens

            Taper off estrogen treatment, then wait month before starting raloxifene

            Examine unexplained uterine bleeding

            Concurrent estrogen treatment

            Hepatic dysfunction

            Premenopausal use not recommended

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Excretion in milk unknown; contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Selective estrogen receptor modulator; estrogenlike effects on bone (decreases bone resorption; increases bone density) and lipid (decrease in LDL); antiestrogenic in uterus, breast

            Absorption

            Bioavailability: 2%

            Absorption: 60%

            Onset: 8 wk

            Distribution

            Protein bound: >95%

            Vd: 2348 L/kg

            Metabolism

            Extensively undergoes first-pass metabolism in the liver to glucuronide conjugates

            Metabolites: Raloxifene-4 glucuronide, raloxifene-6 glucuronide (inactive)

            Elimination

            Half-life: 27.7-32.5 hr

            Excretion: Feces (>93%); urine (<0.2%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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