What information is important for the nurse to teach a client recently prescribed raloxifene?

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

Calcium and vitamin D supplementation

• Postmenopausal patients should take supplemental calcium and vitamin D if dietary intake is not adequate
• 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
• 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

Breast cancer risk

• 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

Interactions

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Enter a drug name and raloxifene

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Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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Contraindicated (1)

• ospemifene

  ospemifene, raloxifene. Either increases effects of the other by pharmacodynamic synergism. Contraindicated.

Serious - Use Alternative (0)

Monitor Closely (4)

• apalutamide

  apalutamide will decrease the level or effect of raloxifene by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and may decrease systemic exposure of drugs that are UGT substrates.

• cholestyramine

  cholestyramine decreases levels of raloxifene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

• famciclovir

  raloxifene decreases levels of famciclovir by aldehyde dehydrogenase inhibition. Use Caution/Monitor. The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase. Interactions with other drugs metabolized by this enzyme and/or inhibiting this enzyme could potentially occur. Raloxifene, a potent aldehyde oxidase inhibitor in vitro, could decrease the formation of penciclovir.

• levothyroxine

  raloxifene decreases levels of levothyroxine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

Minor (0)

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

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

Associated with increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis

Increased risk of death due to stroke; consider risk-benefit balance in women at risk for stroke

Supplemental calcium and vitamin D recommended

Therapy should not be used for primary or secondary prevention of cardiovascular disease

Triglyceride levels may increase in women with history of triglyceride elevation in response to oral estrogens; monitor serum triglycerides

Concomitant use of estrogens not recommended; taper off estrogen treatment, then wait month before starting raloxifene

Examine unexplained uterine bleeding

Use with caution in renal or hepatic impairment

Premenopausal use not recommended

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.

Pharmacology

Mechanism of Action

Selective estrogen receptor modulator; estrogenlike effects on bone (decreases bone resorption; increase 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%)

Images

BRAND	FORM.	UNIT PRICE	PILL IMAGE
raloxifene oral -	60 mg tablet
raloxifene oral -	60 mg tablet
raloxifene oral -	60 mg tablet
raloxifene oral -	60 mg tablet
raloxifene oral -	60 mg tablet

Copyright © 2010 First DataBank, Inc.

Patient Handout

RALOXIFENE - ORAL

(ral-OX-i-feen)

COMMON BRAND NAME(S): Evista

WARNING: Raloxifene may rarely cause serious blood clots, especially in the legs or lungs. Women who have or had blood clots (including in the legs, lungs, or eyes) should not take raloxifene. Also, women who have had a heart attack or are at risk for a heart attack may rarely have an increased risk of dying from a stroke while taking raloxifene. Before starting treatment with raloxifene, tell your doctor if you have or had blood clots in your legs/lungs/eyes, a stroke, mini-stroke (TIA), heart disease, heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, or if you smoke. Discuss these risks and the benefits of using raloxifene with your doctor.

USES: Raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. It slows down bone loss and helps to keep bones strong, making them less likely to break.Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive breast cancer) after menopause.Raloxifene is not an estrogen hormone, but it acts like estrogen in some parts of the body, like your bones. In other parts of the body (uterus and breasts), raloxifene acts like an estrogen blocker. It does not relieve menopause symptoms such as hot flashes. Raloxifene belongs to a class of drugs known as selective estrogen receptor modulators-SERMs.This medication should not be used before menopause.It should not be used to prevent heart disease.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking raloxifene and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Swallow the tablet whole. Do not crush or chew because the drug has a bitter taste.Be sure to get enough calcium and vitamin D in your diet. Consult your doctor or pharmacist to see if you need to take calcium and vitamin D supplements.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

SIDE EFFECTS: Hot flashes or leg cramps may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Get medical help right away if you have any very serious side effects, including: signs of a blood clot (such as sudden pain/swelling/redness/warmth in the leg or arm, chest pain, trouble breathing, coughing up blood, sudden vision changes like blurred vision/loss of vision), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (including in the legs/lungs/eyes), stroke, mini-stroke (TIA), heart disease (blocked blood vessels in the heart), heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, smoking, kidney disease, liver disease, heart failure, cancer, high blood fat (triglyceride) levels caused by estrogen treatment.Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using raloxifene. You may need to stop this medication for a time or take special precautions.This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: bile acid-binding resins (such as cholestyramine, colestipol), estrogens, tibolone.This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: dizziness, vomiting.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as bone density tests, X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments.You should have regular complete physical exams (for example, once a year) which include breast and pelvic exams, and Pap smear. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts. Report any unusual vaginal bleeding, breast pain, or lumps right away.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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