RxLink: Rxlink LLC - DEXILANT (dexlansoprazole) from TAKEDA Pharmaceuticals

To RxLink: 03-06-12 From Takeda Pharmaceuticals North America, INC.

Takeda Pharmaceuticals North America, INC. (TAKEDA) recently announced an important update to the DEXILANT prescribing label. The labeling now states that concomitant administration of dexlansoprazole and clopidogrel had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition in healthy sublets. No dose adjustment of clopidogrel is necessary when administered with an approved dose of DEXILANT.

A study of healthy subjects who were CYP2C19 extensive metabolizers receiving once daily administration of clopdogrel 75mg alone or concomitantly with DEXILANT 60mg (n=40) for 9 days was conducted. this study showed that the mean AUC of the active metabolite of clopidogrel was reduced by approximately 9% (mean AUC ratio was 91%, with 90% Cl of 86% - 97%) when DEXILANT was coadministration information.

Important Safety Information

Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
Most commonly reported adverse reactions were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%)

Indications for DEXILANT

Healing all grades of erosive esophagitis (EE) for up to 8 weeks
Maintaining healing of EE and relief of heartburn for up to 6 months
Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.

Gilles Delecoeuillerie, MD., Ph.D.
Executive Medical Director, Medical & Scientific Affairs... RxLink LLC - RxLink Pharmacy Franchise - 2016 - All Rights Reserved RxLink is a Registered TradeMark of RxLink LLC.