Raloxifene

Raloxifene is a prescription drug 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.

Raloxifene should not be used before menopause.

Raloxifene should not be used to prevent heart disease.

Raloxifene is available under the following different brand names: Evista.

Dosage of Raloxifene:

Adult dosage only. Not recommended for pediatric use.

Dosing Consideraations – Should be Given as Follows:

Dietary Supplement

Osteoporosis in Post-Menopausal Women

• 60 mg orally each day

Breast Cancer

• Prevention; risk reduction of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer
• 60 mg orally each day 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 greater than 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

Adult dosage only. Not recommended for pediatric use.

Dosing Consideraations – Should be Given as Follows:

Dietary Supplement

Osteoporosis in Post-Menopausal Women

• 60 mg orally each day

Breast Cancer

• Prevention; risk reduction of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer
• 60 mg orally each day 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 greater than 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

Side effects of raloxifene include:

• hot flashes
• flu syndrome
• cramps/muscle spasm
• infection
• insomnia
• vomiting
• bronchitis
• sore throat
• breast pain
• infectious diarrhea
• decreased fibrinogen protein in the blood
• headache
• increased sweating
• dizziness
• spinning sensation (vertigo)
• joint pain
• nausea
• stomach pain
• runny or stuffy nose
• stroke
• blood clots in the legs, lungs, or eyes

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of raloxifene include:
  • ospemifene
• Raloxifene has no known serious interactions with other drugs.
• Moderate interactions of raloxifene include:
  • cholestyramine
  • famciclovir
  • levothyroxine
• Mild interactions of raloxifene include:
  • warfarin

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

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.

This medication contains raloxifene. Do not take Evista if you are allergic to raloxifene or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Pregnancy, lactation
• Active history of thromboembolic disorders
• Women who could become pregnant

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Raloxifene?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Raloxifene?"

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

Pregnancy and Lactation

• There is no available information of raloxifene use during pregnancy
• Consult with your physician
• Raloxifene excretion in breast milk is unknown and its use is contraindicated when breastfeeding