Generic Medicine Info
Indications and Dosage
Postmenopausal osteoporosis
Adult: Treatment and prophylaxis: 60 mg once daily. Recommended therapeutic indications may vary between countries (refer to specific product guidelines).

Reduction of breast cancer incidence in women at high risk
Adult: To reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women with high risk of invasive breast cancer: 60 mg once daily for 5 years. Recommended therapeutic indications may vary between countries (refer to specific product guidelines).
Renal Impairment
Severe: Contraindicated.
Hepatic Impairment
May be taken with or without food.
Active or history of venous thromboembolic events (e.g. DVT, pulmonary embolism, retinal vein thrombosis); unexplained uterine bleeding; patients with signs and symptoms of endometrial cancer; cholestasis. Hepatic and severe renal impairment. Women of childbearing potential, pregnant and premenopausal women; lactation.
Special Precautions
Patient with documented coronary heart disease and risk factors for major coronary events, stroke (e.g. history of stroke, TIA, atrial fibrillation, hypertension, smoking), or thromboembolism (e.g. active malignancy, CHF, superficial thrombophlebitis); history of breast cancer and oral-estrogen induced hypertriglyceridaemia (>5.6 mmol/L or >500 mg/dL). Patients on prolonged immobilisation (e.g. post-surgical recovery, prolonged bed rest). Not indicated to be used for primary or secondary prevention of CV disease, treatment of invasive breast cancer, and risk reduction in non-invasive breast cancer. Not indicated for use in men. The safety of concomitant use with systemic estrogen therapy has not been established; concurrent use is not recommended. Mild to moderate renal impairment.
Adverse Reactions
Significant: Increased serum triglycerides (particularly in patients with history of estrogen-induced hypertriglyceridaemia); vaginal bleeding.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, flatulence.
General disorders and administration site conditions: Peripheral oedema.
Investigations: Increased blood pressure, weight gain.
Musculoskeletal and connective tissue disorders: Leg cramps, arthralgia, muscle spasms, myalgia, tendinopathy.
Nervous system disorders: Headache, migraine.
Psychiatric disorders: Depression, insomnia.
Renal and urinary disorders: UTI.
Reproductive system and breast disorders: Breast pain, enlargement, or tenderness; leukorrhoea, uterine or endometrium disease.
Respiratory, thoracic and mediastinal disorders: Flu syndrome, bronchitis, sinusitis, pharyngitis, pneumonia, laryngitis.
Skin and subcutaneous tissue disorders: Rash, sweating.
Vascular disorders: Hot flushes, superficial vein thrombophlebitis.
Potentially Fatal: Increased risk of venous thromboembolic events, including DVT, pulmonary embolism, and retinal vein thrombosis; stroke.
Patient Counseling Information
For postmenopausal osteoporosis treatment or prophylaxis: Ensure adequate Ca and vitamin D intake.
Monitoring Parameters
Monitor mammogram and breast exam prior to and regularly during treatment; lipid profile (in patients at risk for hypertriglyceridemia). Assess for unexplained uterine bleeding or breast abnormalities and signs or symptoms of thromboembolism. For postmenopausal osteoporosis treatment or prophylaxis: Obtain serial BMD at baseline and every 1 to 3 years; serum Ca and 25-hydroxy vitamin D; annual height or weight measurement.
Drug Interactions
Reduced absorption and enterohepatic recycling with colestyramine or other anion exchange resins. May decrease the efficacy of warfarin or other coumarin derivatives; closely monitor prothrombin time. May reduce the absorption of levothyroxine.
Mechanism of Action: Raloxifene is a selective estrogen receptor modulator (SERM) that has selective agonistic or antagonistic effects on tissues responsive to estrogen. It acts as an estrogen agonist in the bone by decreasing bone resorption and turnover, increasing bone mineral density and reducing fracture incidence. Raloxifene exerts an antagonistic activity by inhibiting some estrogen effects in the breast and uterine tissues.
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 2%.
Distribution: Widely distributed in the body. Volume of distribution: 2,348 L/kg. Plasma protein binding: 98-99%, mainly to albumin and α1-acid glycoprotein.
Metabolism: Undergoes extensive first-pass metabolism in the liver to form glucuronide conjugates; undergoes enterohepatic recycling.
Excretion: Mainly via faeces; urine (<0.2% as unchanged drug, <6% as glucuronide conjugates). Elimination half-life: 27.7 hours (after a single dose); 32.5 hours (after multiple doses).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5035, Raloxifene. https://pubchem.ncbi.nlm.nih.gov/compound/Raloxifene. Accessed Jan. 25, 2024.

Store between 15-30°C. Protect from excessive heat, light and moisture. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
G03XC01 - raloxifene ; Belongs to the class of selective estrogen receptor modulators.
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Anon. Raloxifene. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/08/2023.

Buckingham R (ed). Raloxifene Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/08/2023.

Eli Lilly and Company (NZ) Limited. Evista 60 mg Tablet data sheet 18 March 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 08/08/2023.

Evista 60 mg Film-coated Tablets (Lotus Pharmaceutical Co Ltd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/08/2023.

Evista Tablet (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/08/2023.

Joint Formulary Committee. Raloxifene Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/08/2023.

Raloxifene 60 mg Film-coated Tablets (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/08/2023.

Disclaimer: This information is independently developed by MIMS based on Raloxifene from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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