EVISTA- raloxifene hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

RALOXIFENE HYDROCHLORIDE

Složení:

RALOXIFENE HYDROCHLORIDE 60 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] . EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)] . EVISTA is 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-

Přehled produktů:

EVISTA 60 mg tablets are white, elliptical, and film coated. They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink. They are available as follows: Bottles of 30 (unit of use) NDC 54868-4170-0 Bottles of 60 NDC 54868-4170-1 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.

Stav Autorizace:

New Drug Application

Informace pro uživatele

EVISTA - RALOXIFENE HYDROCHLORIDE TABLET
Physicians Total Care, Inc.
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Medication Guide
EVISTA® (Ē-VISS-tah)
(raloxifene hydrochloride tablets)
Tablets for Oral Use
Read the Medication Guide that comes with EVISTA 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 EVISTA
when you start taking it and at regular checkups.
What is the most important information I should know about EVISTA?
Serious and life-threatening side effects can occur while taking
EVISTA. 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 EVISTA. Women who have or have had blood clots
in the legs, lungs, or
eyes should not take EVISTA.
•
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 EVISTA.
1.
Before starting EVISTA, 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 EVISTA 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
EVISTA?”)
What is EVISTA?
EVISTA is a type of prescription medicine called a Selective Estrogen
Receptor Modulator (SERM).
EVISTA is for women after menopause, and has more than one use:
•
Osteoporosis: EVISTA treats and prevents osteoporosis by helping make
your bones st

Charakteristika produktu

EVISTA - RALOXIFENE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVISTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EVISTA.
EVISTA (RALOXIFENE HYDROCHLORIDE) TABLET 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 EVISTA
(5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF VENOUS THROMBOEMBOLISM
SHOULD NOT TAKE EVISTA (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).
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
EVISTA 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: EVISTA is 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, women who may become pregnant, and nursing mothers. (4.2,
8.1, 8.3)
WARNINGS AND PRECAUTIONS
_Venous Thromboembolism_: Increased risk of deep vein thrombosis,
pulmonary embolism, and retinal vein thrombosis.
Discontinue use 72 hours prior to and during prolonged immobil