Raloxifene Hydrochloride (Evista)

Trade Name : Evista

Eli Lilly and Company

TABLET

Strength 60 mg/1

Storage and handling for Evista

RALOXIFENE HYDROCHLORIDE Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Raloxifene Hydrochloride (Evista) which is also known as Evista and Manufactured by Eli Lilly and Company. It is available in strength of 60 mg/1 per ml. Read more

Raloxifene Hydrochloride (Evista) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKEn
See full prescribing information for complete boxed warning.

Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA (). Women with active or past history of venous thromboembolism should not take EVISTA ().
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 (, ).

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EVISTA is an estrogen agonist/antagonist indicated for:n
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. ()n

Treatment and prevention of osteoporosis in postmenopausal women. ()n
Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ()n
Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ()n

60 mg tablet orally once daily. ()n

60 mg, white, elliptical, film-coated tablets (not scored) imprinted with either 4165 or LILLY 4165 on one side in edible blue ink.n
Tablets (not scored): 60 mg ()n

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Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ()n
Pregnancy. (, )n

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Venous Thromboembolism
Death Due to Stroke
Cardiovascular Disease
Premenopausal Women
Hepatic Impairment
Concomitant Use with Systemic Estrogens
Hypertriglyceridemia

Adverse reactions (>2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. ()n
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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Cholestyramine
Warfarin
Highly Protein-Bound Drugs

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Pediatric Use: Safety and effectiveness not established. ()n

In an 8-week study of 63 postmenopausal women, a dose of raloxifene hydrochloride (HCl) 600u00a0mg/day was safely tolerated. In clinical trials, no raloxifene overdose has been reported.n
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 1.5u00a0grams. No fatalities associated with raloxifene overdose have been reported. Adverse reactions were reported in approximately half of the adults who took u2265180u00a0mg raloxifene HCl and included leg cramps and dizziness.n
Two 18-month-old children each ingested raloxifene HCl 180u00a0mg. In these two children, symptoms reported included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, as well as elevation in alkaline phosphatase.n
There is no specific antidote for raloxifene.n
No mortality was seen after a single oral dose in rats or mice at 5000u00a0mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m) or in monkeys at 1000u00a0mg/kg (80 times the AUC in humans).n

EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:n
The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula CHNOSu2022HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.n
EVISTA is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60u00a0mg of raloxifene HCl, which is the molar equivalent of 55.71u00a0mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.n

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See FDA-approved Medication Guide.
Physicians should instruct their patients to read the Medication Guide before starting therapy with EVISTA and to reread it each time the prescription is renewed.n

Medication Guide
EVISTA (u0112-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.n
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:n
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:n
EVISTA is not for use in premenopausal women (women who have not passed menopause).n
Who should not take EVISTA?
Do not take EVISTA if you:n
What should I tell my doctor before taking EVISTA?
EVISTA may not be right for you. Before taking EVISTA, tell your doctor about all your medical conditions, including if you:n
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*:n
EVISTA should not be taken with cholestyramine or estrogens.n
How should I take EVISTA?
What should I avoid while taking EVISTA?
What are the possible side effects of EVISTA?
Serious and life-threatening side effects can occur while taking EVISTA. These include blood clots and dying from stroke:n
See n
The most common side effects of EVISTA 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.n
These are not all the side effects of EVISTA. Tell your doctor about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
What else should I know about EVISTA?
How should I store EVISTA?
General Information about the safe and effective use of EVISTA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EVISTA for a condition for which it was not prescribed. Do not give your EVISTA to other people, even if they have the same symptoms you have. It may harm them.n
This Medication Guide is a summary of the most important information about EVISTA. If you would like more information about EVISTA, talk with your doctor. You can ask your doctor or pharmacist for information about EVISTA that is written for health professionals. For more information, call 1-800-545-5979 (toll-free).n
What are the ingredients in EVISTA?
Active Ingredient:
Inactive Ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.n
*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.n
Medication Guide revised August 1, 2014n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright u00a9 1997, 2014, Eli Lilly and Company. All rights reserved.n
EVS-0001-MG-20140801n

PACKAGE LABEL u2013 Evista 60mg 100ct Bottle (0002-4184)
NDC 0002-4184-02n
100 Tabletsn
No. 4165n
EVISTAn
raloxifene HCl tablets 60mgn
4165
Rx onlyn
Lillyn

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