Raloxifene Hydrochloride (Page 8 of 9)

14.5 Effects on Cardiovascular Disease

In a randomized, placebo-controlled, double-blind, multinational clinical trial (RUTH) of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene HCl 60 mg once daily for a median follow-up of 5.6 years. No significant increase or decrease was observed for coronary events (death from coronary causes, nonfatal myocardial infarction, or hospitalization for an acute coronary syndrome). An increased risk of death due to stroke after treatment with raloxifene HCl was observed: 59 (1.2%) raloxifene HCl-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women (2.2 versus 1.5 per 1000 women-years; hazard ratio 1.49; 95% confidence interval, 1 to 2.24; p=0.0499). The incidence of stroke did not differ significantly between treatment groups (249 with raloxifene HCl [4.9%] versus 224 with placebo [4.4%]; hazard ratio 1.10; 95% confidence interval 0.92 to 1.32; p=0.30; 9.5 versus 8.6 per 1000 women-years) [see Warnings and Precautions (5.2,5.3)] .

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Raloxifene HCl tablets, USP, 60 mg, are supplied as white to off-white, elliptical shaped, film–coated tablets debossed with “AN057” on one side and plain on the other side. They are available as follows:

NDC 50268-694-15 (10 tablets per card, 5 cards per carton)

Dispensed in Unit Dose Package. For Institutional Use Only.

16.2 Storage and Handling

Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [ see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals and warehouses. Dispense in tight containers.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide.

Physicians should instruct their patients to read the Medication Guide before starting therapy with raloxifene HCl and to reread it each time the prescription is renewed.

17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation

For osteoporosis treatment or prevention, patients should be instructed to take supplemental calcium and/or vitamin D if intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, chronically ill, or with gastrointestinal malabsorption syndromes) should be instructed to take additional vitamin D if needed. Weight-bearing exercises should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.

17.2 Patient Immobilization

Raloxifene HCl should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and patients should be advised to avoid prolonged restrictions of movement during travel because of the increased risk of venous thromboembolic events [see Warnings and Precautions (5.1)] .

17.3 Hot Flashes or Flushes

Raloxifene HCl may increase the incidence of hot flashes and is not effective in reducing hot flashes or flushes associated with estrogen deficiency. In some asymptomatic patients, hot flashes may occur upon beginning raloxifene HCl therapy.

17.4 Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis or at High Risk of Invasive Breast Cancer

Use of raloxifene HCl is associated with the reduction of the risk of invasive breast cancer in postmenopausal women. Raloxifene HCl has not been shown to reduce the risk of noninvasive breast cancer. When considering treatment, physicians need to discuss the potential benefits and risks of raloxifene HCl treatment with the patient.

Raloxifene HCl is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.

Patients should have breast exams and mammograms before starting raloxifene HCl and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene HCl.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 05-2016-01

Medication Guide

Raloxifene (ra-LOX-i-feen) HCl Tablets for Oral Use

Read the Medication Guide that comes with raloxifene HCl before you start taking it and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene HCl when you start taking it and at regular checkups.

What is the most important information I should know about raloxifene HCl?

Serious and life-threatening side effects can occur while taking raloxifene HCl. These include blood clots and dying from stroke:

  • Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene HCl. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene HCl.
  • Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene HCl.

1. Before starting raloxifene HCl, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), or have an irregular heartbeat.

2. Stop taking raloxifene HCl and call your doctor if you have:

  • leg pain or a feeling of warmth in the lower leg (calf).
  • swelling of the legs, hands, or feet.
  • sudden chest pain, shortness of breath, or coughing up blood.
  • sudden change in your vision, such as loss of vision or blurred vision.

3. Being still for a long time (such as sitting still during a long car or airplane trip or being in bed after surgery) can increase your risk of blood clots. (See “What should I avoid if I am taking raloxifene HCl?”)

What is raloxifene HCl?

Raloxifene HCl is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene HCl is for women after menopause, and has more than one use:

• Osteoporosis: Raloxifene HCl treats and prevents osteoporosis by helping make your bones stronger and less likely to break.

• Invasive Breast Cancer: If you have osteoporosis or are at high risk for breast cancer, raloxifene HCl can be used to lower your chance of getting invasive breast cancer. Raloxifene HCl will not totally get rid of your chance of getting breast cancer. Your doctor can estimate your risk of breast cancer by asking you about risk factors, including:

  • your age (getting older).
  • family history of breast cancer in your mother, sister, or daughter.
  • a history of any breast biopsy, especially an abnormal biopsy.

You and your doctor should talk about whether the possible benefit of raloxifene HCl in lowering your chance of getting invasive breast cancer is greater than its possible risks.

Raloxifene HCl is not for use in premenopausal women (women who have not passed menopause).

Who should not take raloxifene HCl ?

Do not take raloxifene HCl if you:

  • have or have had blood clots in your legs, lungs, or eyes. Taking raloxifene HCl may increase the risk of getting blood clots.
  • are pregnant or could become pregnant. Raloxifene HCl could harm your unborn child.
  • are nursing a baby. It is not known if raloxifene HCl passes into breast milk or what effect it might have on the baby.

What should I tell my doctor before taking raloxifene HCl ?

Raloxifene HCl may not be right for you. Before taking raloxifene HCl, tell your doctor about all your medical conditions, including if you:

  • have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (TIA/transient ischemic attack), or a type of irregular heartbeat (atrial fibrillation).
  • have had breast cancer. Raloxifene HCl has not been fully studied in women who have a history of breast cancer.
  • have liver or kidney problems.
  • have taken estrogen in the past and had a high increase of triglycerides (a kind of fat in the blood).
  • are pregnant, planning to become pregnant, or breast-feeding (see “Who should not take raloxifene HCl ?”).

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Especially tell your doctor if you take*:

  • warfarin (Coumadin ® , Jantoven ®)

If you are taking warfarin or other coumarin blood thinners, your doctor may need to do a blood test when you first start or if you need to stop taking raloxifene HCl. Names for this test include “prothrombin time,” “pro-time,” or “INR.” Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinner.

  • cholestyramine
  • estrogens

Raloxifene HCl should not be taken with cholestyramine or estrogens.

How should I take raloxifene HCl?

  • Take raloxifene HCl exactly how your doctor tells you to.
  • Keep taking raloxifene HCl for as long as your doctor prescribes it for you. It is not known how long you should keep taking raloxifene HCl to lower your chance of getting invasive breast cancers.
  • It is important to get your refills on time so you do not run out of the medicine.
  • Take one raloxifene HCl tablet each day.
  • Take raloxifene HCl at any time of the day, with or without food.
  • To help you remember to take raloxifene HCl, it may be best to take it at about the same time each day.
  • Calcium and vitamin D may be taken at the same time as raloxifene HCl. It is important to take calcium and vitamin D, as directed by your physician, to prevent or treat osteoporosis.
  • If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take two doses at the same time.

What should I avoid while taking raloxifene HCl?

  • Being still for a long time (such as during long trips or being in bed after surgery) can increase the risk of blood clots. Raloxifene HCl may add to this risk. If you will need to be still for a long time, talk with your doctor about ways to reduce the risk of blood clots. On long trips, move around periodically. Stop taking raloxifene HCl at least 3 days before a planned surgery or before you plan on being still for a long time. You should start taking raloxifene HCl again when you return to your normal activities.
  • Some medicines should not be taken with raloxifene HCl (see “What should I tell my doctor before taking raloxifene HCl?”).

What are the possible side effects of raloxifene HCl?

Serious and life-threatening side effects can occur while taking raloxifene HCl. These include blood clots and dying from stroke:

  • Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene HCl. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene HCl.
  • Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene HCl.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See “What is the most important information I should know about raloxifene HCl?”

The most common side effects of raloxifene HCl are hot flashes, leg cramps, swelling of the feet, ankles and legs, flu syndrome, joint pain and sweating. Hot flashes are more common during the first 6 months after starting treatment.

These are not all the side effects of raloxifene HCl. Tell your doctor about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking raloxifene HCl, ask your doctor or pharmacist for more information.

What else should I know about raloxifene HCl?

  • Do not use raloxifene HCl to prevent heart disease, heart attack, or strokes.
  • To get the calcium and vitamin D you need, your doctor may advise you to change your diet and/or take supplemental calcium and vitamin D. Your doctor may suggest other ways to help treat or prevent osteoporosis, in addition to taking raloxifene HCl and getting the calcium and vitamin D you need. These may include regular exercise, stopping smoking and drinking less alcohol.
  • Women who have hot flashes can take raloxifene HCl. Raloxifene HCl does not treat hot flashes, and it may cause hot flashes in some women. (See “What are the possible side effects of raloxifene HCl?”)
  • Raloxifene HCl has not been found to cause breast tenderness or enlargement. If you notice any changes in your breasts, call your doctor to find out the cause. Before starting and while taking raloxifene HCl you should have breast exams and mammograms, as directed by your doctor. Because raloxifene HCl does not eliminate the chance of developing breast cancers, you need these examinations to find any breast cancers as early as possible.
  • Raloxifene HCl should not cause spotting or menstrual-type bleeding. If you have any vaginal bleeding, call your doctor to find out the cause. Raloxifene HCl has not been found to increase the risk for cancer of the lining of the uterus.
  • Women in clinical trials have taken raloxifene HCl for up to eight years.

How should I store raloxifene HCl tablets?

  • Store raloxifene HCl tablets at 68°F to 77°F (20°C to 25°C).
  • Keep raloxifene HCl and all medicines out of the reach of children.

General Information about the safe and effective use of raloxifene HCl

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene HCl for a condition for which it was not prescribed. Do not give your raloxifene HCl to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide is a summary of the most important information about raloxifene HCl. If you would like more information about raloxifene HCl, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene HCl that is written for health professionals. For more information, call 1-855-361-3993 (toll free) or go to the following website: www.avkare.com.

What are the ingredients in raloxifene HCl tablets?

Active Ingredient: raloxifene hydrochloride, USP

Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

* Trademarks are the property of their respective owners.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 05-2016-01

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