RALOXIFENE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RALOXIFENE HYDROCHLORIDE (UNII: 4F86W47BR6) (RALOXIFENE - UNII:YX9162EO3I)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] . Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)] . Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies (14.4)] . The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see Clinical Studies (14.4)] . Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. 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 ≥ 1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty. After an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks. Raloxifene hydrochloride tablets does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets. Important Limitations of Use for Breast Cancer Risk Reduction - There are no data available regarding the effect of raloxifene hydrochloride tablets on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets. - Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. - Raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer. Raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions (5.1)] . Raloxifene hydrochloride is contraindicated for use in pregnancy, as it may cause fetal harm [see Use in Specific Populations (8.1)] . Risk Summary Raloxifene hydrochloride is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential. Based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has during all stages of pregnancy [see Clinical Pharmacology (12.1)] . Limited data with raloxifene hydrochloride use in pregnant women are insufficient to inform any drug associated risks for births defects or miscarriage. In rabbits and rats dosed during organogenesis or during gestation and lactation, raloxifene hydrochloride produced multiple adverse reproductive and developmental effects, including abortion; fetal anomalies; and delayed or disrupted parturition leading to maternal and neonatal mortality, at doses less than or similar to the maximum recommended human dose (based on human body surface area comparison). Data Animal Data In the developmental and reproductive toxicity studies conducted with raloxifene hydrochloride, numerous adverse effects were observed in multiple animal species. In rabbits dosed during organogenesis, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ). In rats dosed during organogenesis, retardation of fetal growth and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m2 ). Treatment of rats during gestation and lactation with doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m2 ) produced effects that included delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring. At 10 mg/kg, the disruption of parturition resulted in maternal and progeny morbidity and death. Effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. Risk Summary Raloxifene hydrochloride is not indicated for use in females of reproductive potential. There is no information on the presence of raloxifene in human milk, the effects on the breastfed child, or the effects on milk production. However, based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has in mammary tissue during lactation [see Clinical Pharmacology (12.1)] . Safety and effectiveness in pediatric patients have not been established. Of the total number of patients in placebo-controlled clinical studies of raloxifene hydrochloride, 61% were 65 and over, while 15.5% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Based on clinical trials, there is no need for dose adjustment for geriatric patients [see Clinical Pharmacology (12.3)] . Raloxifene hydrochloride should be used with caution in patients with moderate or severe renal impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3)] . Raloxifene hydrochloride should be used with caution in patients with hepatic impairment [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)] .

Product summary:

Product: 50090-7073 NDC: 50090-7073-1 90 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM
COATED
A-S Medication Solutions
----------
MEDICATION GUIDE
Raloxifene Hydrochloride Tablets, USP for Oral Use
(ral ox' i feen hye'' droe klor' ide)
Read the Medication Guide that comes with raloxifene hydrochloride
tablets before you start taking them
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 hydrochloride tablets when you start
taking them and at regular checkups.
What is the most important information I should know about raloxifene
hydrochloride tablets?
Serious and life-threatening side effects can occur while taking
raloxifene hydrochloride tablets. 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 hydrochloride tablets. Women who
have or have had blood
clots in the legs, lungs, or eyes should not take raloxifene
hydrochloride tablets.
•
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 hydrochloride tablets.
1. Before starting raloxifene hydrochloride tablets, 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 hydrochloride tablets 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 while taking ra

Summary of Product characteristics

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM
COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RALOXIFENE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
RALOXIFENE HYDROCHLORIDE TABLETS.
RALOXIFENE HYDROCHLORIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM
STROKE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM HAVE
BEEN
REPORTED WITH RALOXIFENE HYDROCHLORIDE (5.1). WOMEN WITH ACTIVE OR
PAST HISTORY OF
VENOUS THROMBOEMBOLISM SHOULD NOT TAKE RALOXIFENE HYDROCHLORIDE (4.1).
INCREASED RISK OF DEATH DUE TO STROKE OCCURRED IN A TRIAL IN
POSTMENOPAUSAL WOMEN
WITH DOCUMENTED CORONARY HEART DISEASE OR AT INCREASED RISK FOR MAJOR
CORONARY
EVENTS. CONSIDER RISK-BENEFIT BALANCE IN WOMEN AT RISK FOR STROKE
(5.2, 14.5).
INDICATIONS AND USAGE
Raloxifene hydrochloride is an estrogen agonist/antagonist indicated
for:
Treatment and prevention of osteoporosis in postmenopausal women.
(1.1)
Reduction in risk of invasive breast cancer in postmenopausal women
with osteoporosis. (1.2)
Reduction in risk of invasive breast cancer in postmenopausal women at
high risk for invasive breast
cancer. (1.3)
Important Limitations: Raloxifene hydrochloride tablets are not
indicated for the treatment of invasive
breast cancer, reduction of the risk of recurrence of breast cancer,
or reduction of risk of noninvasive
breast cancer. (1.3)
DOSAGE AND ADMINISTRATION
60 mg tablet orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 60 mg (3)
CONTRAINDICATIONS
Active or past history of venous thromboembolism, including deep vein
thrombosis, pulmonary
embolism, and retinal vein thrombosis. (4.1)
Pregnancy (4.2, 8.1)
WARNINGS AND PRECAUTIONS
_Venous Thromboembolism: _Increased risk of deep vein thrombosis,
pulmonary embolism, and retinal
vein