LYSTEDA: A non-hormonal medication indicated for cyclic
Heavy Menstrual Bleeding
Over 15,000 of your colleagues have written more than 80,000 presciptions of non-hormonal LYSTEDA – FDA approved to treat cyclic Heavy Menstrual Bleeding.†
LYSTEDA was FDA-approved for cyclic Heavy Menstrual Bleeding in November 2009 and has been on the market since July 2010. It is the only FDA-approved non-hormonal treatment specifically developed for this condition.
Tranexamic acid has been used for decades to control excessive bleeding, with its first approval in the United States in 1986 for excessive dental bleeding. LYSTEDA, a unique tablet formulation of tranexamic acid, is specifically designed to control the excessive bleeding of heavy periods. LYSTEDA acts downstream of the coagulation cascade to help normalize a women’s period*
For Heavy Menstrual Bleeding..
When she wants a non-hormonal therapy for heavy periods, LYSTEDA can help.
LYSTEDA: Antifibrinolytic activity
- Works downstream of the coagulation cascade and slows the dissolution of fibrin, therefore reduces excessive bleeding.
LYSTEDA: Provides significantly lighter periods
- Reduced menstrual blood loss by 66 mL on average, a 38% overall reduction (vs 18 mL [12%] for placebo)**
- Women taking LYSTEDA experienced fewer limitations in social, leisure and physical activities compared with women taking placebo [p<0.05]**
LYSTEDA: Appropriate for a range of patients looking for a non-hormonal treatment
- Clinical trials included a diverse range of women aged 18 to 49 years old
- Women who smoke, have high BMI and fibroids were also included in the trials
- LYSTEDA is Pregnancy Category B
LYSTEDA: A therapy she takes only during her periods
- She starts taking LYSTEDA at the first sign of menstrual bleeding
- From day 1, the recommended dose is two 650-mg tablets taken 3 times a day for women with normal renal function
- Taken 3 times a day for up to 5-days during each period
LYSTEDA: Discontinuation rates comparable to placebo
- 2.4% of patients taking LYSTEDA discontinued due to adverse events in a 6-cycle study, compared with 4.1% in the placebo group
Data from two clinical studies of women ages 18-49 years with cyclic heavy menstrual bleeding showed that LYSTEDA
3,900 mg/day significantly and consistently reduced menstrual blood loss (MBL) compared
with placebo. LYSTEDA also significantly reduced limitations in physical, social
and leisure activities compared with placebo*.
Download a brochure for healthcare professionals about LYSTEDA.
Read more about LYSTEDA:
† Data on file Ferring Pharmaceuticals Inc.
* LYSTEDA is an antifibrinolytic – inhibiting fibrinolysis downstream from the coagulation cascade to help preserve the fibrin matrix and reduce HMB.
** Randomized, double-blind, placebo-controlled, 6-cycle clinical trial of 187 women. Dosing was two 650 mg tablets of LYSTEDA TID (3900 mg/day) or placebo for up to 5 days during menstruation. Heavy menstrual bleeding was defined as an average menstrual blood loss (MBL) ≥80 mL as assessed
over 2 baseline menstrual cycles.
Indications & Usage »