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Clinical Data Demonstrates That LYSTEDA™ Significantly Reduced Menstrual Blood Loss and Limitations on Social, Leisure and Physical Activities in Women With Cyclic HMB
Date:5/19/2010

well tolerated.

Effects of BMI, Age and Fibroids on MBL Reduction

Additional post hoc subgroup analyses were conducted using data from a randomized study of 187 women with HMB (LYSTEDA 3.9 g/day (n=115) or placebo (n=72)).  Results showed that LYSTEDA 3.9 g/day significantly and uniformly reduced MBL, regardless of age, the presence of uterine fibroids, baseline MBL or body mass index (BMI).  

About LYSTEDA

LYSTEDA™ (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding.  Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.  For more information, visit www.lysteda.com.

Important Safety Information

LYSTEDA is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion; or known hypersensitivity to tranexamic acid.

Concomitant therapy with hormonal contraceptives may further increase the risk of blood clots, stroke, and myocardial infarction.  Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event.  In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention.  Visual or ocular adverse effects may occur with LYSTEDA.  Immediately discontinue use if visual or ocular symptoms occur.  Concomitant u
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SOURCE Ferring Pharmaceuticals Inc.
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