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Evista (raloxifene)

Indications

Evista tablets are prescribed for the following conditions:

• Osteoporosis Prevention and Treatment: Used to prevent and treat osteoporosis in postmenopausal women by helping to maintain bone density and reduce the risk of fractures.
• Breast Cancer Risk Reduction: Reduces the risk of invasive breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer.

Dosage and Administration

• Follow your doctor’s prescription exactly. Evista is typically taken once daily.
• Swallow the tablet whole with water.
• Take Evista at the same time each day to maintain an even level of medication in your body.
• Ensure adequate intake of calcium and vitamin D as advised by your doctor to support bone health.
• Do not skip doses as it can reduce the effectiveness of the treatment.
• Don’t double up a dose to make up for a missed one.

Mechanism of Action

Evista (Raloxifene) is a selective estrogen receptor modulator (SERM). It acts by mimicking the effects of estrogen on bone and lipid metabolism, while blocking estrogen’s effects on breast and uterine tissues. This helps maintain bone density, reduce the risk of fractures, and lower the risk of invasive breast cancer.

Contraindications

Evista should not be used if you:

• Are Allergic to Raloxifene: Any known hypersensitivity to Raloxifene or any component of Evista tablets.
• Have a History of Blood Clots: Such as deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis.
• Are Pregnant or Breastfeeding: Evista is contraindicated during pregnancy and breastfeeding due to potential harm to the fetus or nursing infant.
• Have Severe Liver Disease: Significant liver impairment can be exacerbated by raloxifene.

Side Effects

Common Side Effects:

• Hot flashes
• Leg cramps
• Swelling of the legs and feet
• Flu-like symptoms
• Joint pain

Serious Side Effects:

• Blood Clots: Pain, swelling, warmth in the leg (deep vein thrombosis), sudden chest pain, or difficulty breathing (pulmonary embolism).
• Severe Allergic Reactions: Rash, itching, swelling, severe dizziness, or trouble breathing.
• Stroke: Sudden numbness or weakness, especially on one side of the body, severe headache, confusion, trouble speaking, or vision problems.

Precautions

• Monitor Health Changes: Be aware of any unusual changes or reactions in your body and inform your doctor immediately.
• Regular Screening: Regular breast exams, mammograms, and pelvic exams are essential while taking Evista.
• Inform About All Medications: Provide a full list of all medications, including over-the-counter drugs and supplements, to your healthcare provider.
• Avoid Prolonged Immobility: If you need to be inactive for long periods, discuss preventive measures for blood clots with your doctor.
• Healthy Lifestyle: Maintain a balanced diet, exercise regularly, and avoid smoking to support overall health and reduce the risk of side effects.

Storage Instructions

• Keep Evista tablets at a temperature between 68°F to 77°F (20°C to 25°C).
• Store in a dry place; avoid bathrooms and kitchens where humidity is high.

References

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf