Raloxifene

Common Side Effects of Evista

Tell your doctor if any of the following symptoms become severe or don't go away:

• Leg cramps
• Hot flashes
• Joint pain
• Flu-like symptoms
• Sweating
• Difficulty falling asleep or staying asleep

Serious Side Effects of Evista

Tell your doctor immediately if you experience any of the symptoms listed in the Warning section or any of the following serious side effects:

• Lumps or other changes in your breasts
• Numbness or weakness, especially on one side of the body
• Sudden, severe headache
• Slurred speech
• Problems with vision or balance
• Signs of an allergic reaction, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Included as part of the PRECAUTIONS section.

In an 8-week study of 63 postmenopausal women, a dose of raloxifene hydrochloride (HCl) 600 mg/day was safely tolerated. In clinical trials, no raloxifene overdose has been reported.

In postmarketing spontaneous reports, raloxifene overdose has been reported very rarely (less than 1 out of 10,000 [ < 0.01%] patients treated). The highest overdose has been approximately 1.5 grams. No fatalities associated with raloxifene overdose have been reported. Adverse reactions were reported in approximately half of the adults who took ≥ 180 mg raloxifene HCl and included leg cramps and dizziness.

Two 18-month-old children each ingested raloxifene HCl 180 mg. In these two children, symptoms reported included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, as well as elevation in alkaline phosphatase.

There is no specific antidote for raloxifene.

No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m²) or in monkeys at 1000 mg/kg (80 times the AUC in humans).

If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of raloxifene. Read this paper carefully and ask your health care professional if you need additional information or explanation.

Many patients trying to prevent or treat bone loss will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed.

Dosing

The dose of raloxifene will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of raloxifene. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For preventing bone loss:
    • Adults—60 mg once a day, with or without meals.
  • For treating bone loss:
    • Adults—60 mg once a day, with or without meals.
  • For preventing invasive breast cancer:
    • Adults—60 mg once a day, with or without meals .

Missed Dose

If you miss a dose of raloxifene, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Raloxifene AUC was 122% higher in patients with moderate to severe renal impairment.

Osteoporosis: Treatment and prevention of osteoporosis in postmenopausal women

Risk reduction for invasive breast cancer: Risk reduction of invasive breast cancer in postmenopausal women with osteoporosis; risk reduction of invasive breast cancer in postmenopausal women with high risk for invasive breast cancer (high risk is defined as at least 1 breast biopsy showing lobular carcinoma in situ or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer 1.66% or more [based on the modified Gail model]; factors included in the modified Gail model include current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity, or age of first live birth).

Limitations of use: Raloxifene does not eliminate the risk of breast cancer; patients should have a breast exam and mammogram prior to initiating raloxifene and continue regular breast exams and mammograms as per current guideline recommendations. Raloxifene is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. Raloxifene is not indicated for the reduction of the risk of noninvasive breast cancer. There are no data available regarding the effect of raloxifene on invasive breast cancer incidence in women with inherited mutations BRCA1, BRCA2 to be able to make specific recommendations on the effectiveness of raloxifene.

>10%:

Cardiovascular: Peripheral edema (3% to 14%)

Endocrine & metabolic: Hot flash (8% to 29%)

Infection: Infection (11%)

Neuromuscular & skeletal: Arthralgia (11% to 16%), leg cramps (≤12%), muscle spasm (≤12%)

Respiratory: Flu-like symptoms (14% to 15%)

1% to 10%:

Cardiovascular: Chest pain (3%), syncope (<2%), venous thromboembolism (1% to 2%; includes deep vein thrombosis, pulmonary embolism, retinal vein thrombosis)

Central nervous system: Insomnia (6%), hypoesthesia (<2%), neuralgia (<2%)

Dermatologic: Skin rash (6%), diaphoresis (3%)

Endocrine & metabolic: Weight gain (9%)

Gastrointestinal: Abdominal pain (7%), vomiting (5%), gastrointestinal disease (3%), flatulence (2% to 3%), gastroenteritis (≤3%)

Genitourinary: Vaginal hemorrhage (3% to 6%), mastalgia (4%), leukorrhea (3%), urinary tract abnormality (3%), uterine disease (3%), endometrium disease (≤3%)

Neuromuscular & skeletal: Myalgia (8%), tendon disease (4%)

Respiratory: Bronchitis (10%), sinusitis (10%), pharyngitis (8%), pneumonia (3%), laryngitis (≤2%)

<1%, postmarketing, and/or case reports: Cerebrovascular accident, decreased LDL cholesterol (Delmas 1997; Walsh 1998), decreased serum cholesterol (Delmas 1997; Walsh 1998), decreased serum fibrinogen (Walsh 1998), hypertriglyceridemia (in women with a history of increased triglycerides in response to oral estrogens), retinal vein occlusion, superficial thrombophlebitis

Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene. Women with active VTE or a history of VTE should not take raloxifene.

Increased risk of death caused by stroke occurred in a trial in postmenopausal women with documented coronary heart disease or increased risk for major coronary reactions. Consider the risk-benefit balance in women at risk for stroke.

Commonly reported side effects of raloxifene include: infection, flu-like symptoms, hot flash, and sinusitis. Other side effects include: leg cramps. See below for a comprehensive list of adverse effects.

Applies to raloxifene: oral tablet

Along with its needed effects, raloxifene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking raloxifene and get emergency help immediately if any of the following effects occur:

• Coughing blood
• headache or migraine headache
• loss of or change in speech, coordination, or vision
• pain or numbness in chest, arm, or leg
• shortness of breath (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur while taking raloxifene:

• Bloody or cloudy urine
• chest pain
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, runny nose, and loss of voice
• leg cramping
• skin rash
• swelling of hands, ankles, or feet
• vaginal itching

• Abdominal pain (severe)
• aching body pains
• congestion in lungs
• decreased vision or other changes in vision
• diarrhea
• difficulty in breathing
• hoarseness
• loss of appetite
• nausea
• trouble in swallowing
• weakness

Some side effects of raloxifene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Hot flashes, including sudden sweating and feelings of warmth (especially common during the first 6 months of treatment)
• increased white vaginal discharge
• joint or muscle pain
• mental depression
• problems of stomach or intestines, including passing of gas, upset stomach, or vomiting
• swollen joints
• trouble in sleeping
• weight gain (unexplained)

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.

Hepatic Impairment: Use with caution.