Generic Name: Raloxifene Brand Name(s): Generics only. No brands available.

Uses

What is Raloxifene used for?

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 should I take Raloxifene?

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.

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.

How do I store Raloxifene?

Raloxifene is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Raloxifene in the bathroom or the freezer. There may be different brands of Raloxifene that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Raloxifene down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Raloxifene?

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. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Raloxifene during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Raloxifene. Raloxifene is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Raloxifene?

Hot flashes or leg cramps may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Raloxifene?

Some products that may interact with this drug include: bile acid-binding resins (such as cholestyramine, colestipol), estrogens.

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.

Raloxifene may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Raloxifene?

Raloxifene may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Raloxifene?

Raloxifene may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Raloxifene.

What is the dose of Raloxifene for an adult?

Usual Adult Dose for Osteoporosis

60 mg orally per day

Comments:

-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.

-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:

-Treatment and prevention of osteoporosis in postmenopausal women.

-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Osteoporosis

60 mg orally per day

Comments:

-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.

-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:

-Treatment and prevention of osteoporosis in postmenopausal women.

-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Breast Cancer

60 mg orally per day

Comments:

-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.

-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:

-Treatment and prevention of osteoporosis in postmenopausal women.

-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Renal Dose Adjustments

-Mild Renal Impairment (CrCl 51 to 80 mL/min): Data not available.

-Moderate and Severe Renal Impairment (CrCl 50 mL/min or less): Use with caution.

Liver Dose Adjustments

Hepatic Impairment: Use with caution.

Other Comments

Administration Advice:

-Administer this drug any time of day without regard to meals.

General:

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

-Clinical trial findings suggest this drug lacks estrogen-like effects on the uterus and breast tissue.

-Overdosage: There is no specific antidote.

Monitoring:

-Breast exams and mammograms (prior to and during treatment)

What is the dose of Raloxifene for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Raloxifene available?

Raloxifene is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Raloxifene, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 21, 2018 | Last Modified: April 21, 2018

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