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:

Exelan Pharmaceuticals, Inc.

INN (International Name):

RALOXIFENE HYDROCHLORIDE

Composition:

RALOXIFENE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Raloxifene hydrochloride tablets, USP 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

Product summary:

Raloxifene hydrochloride tablets, USP 60 mg are white film coated round biconvex, de-bossed with IG on one side and 256 on the other, supplied in bottle of 30 (NDC 76282-256-30), bottle of 90 (NDC 76282-256-90), bottle of 100 (NDC 76282-256-01), bottle of 500 (NDC 76282-256-05), bottle of 1000 (NDC 76282-256-10). 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
Exelan Pharmaceuticals, Inc.
---------- MEDICATION
GUIDE RALOXIFENE HYDROCHLORIDE
TABLETS, USP FOR ORAL USE
(RAL·OX·I·FENE)
Read the Medication Guide that comes with raloxifene hydrochloride
tablets 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 hydrochloride tablets when you start taking it
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 if I am taking raloxifene
hydrochlo

Summary of Product characteristics

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
EXELAN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RALOXIFENE HYDROCHLORIDE TABLETS, USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RALOXIFENE
HYDROCHLORIDE TABLETS, USP.
RALOXIFENE HYDROCHLORIDE TABLETS, USP 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 TABLETS (5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF
VENOUS THROMBOEMBOLISM SHOULD
NOT TAKE RALOXIFENE HYDROCHLORIDE TABLETS (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
Contraindications, Pregnancy (4.2) 06/2018
Warnings and Precautions, Premenopausal Use (5.4) 06/2018
INDICATIONS AND USAGE
Raloxifene hydrochloride tablet, USP 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 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 thromb