Deerfield, Ill., (April 26, 2010) –Takeda Pharmaceuticals North America, Inc. today announced that DEXILANT™ (dexlansoprazole) delayed release capsules are now available in United States (U.S.) pharmacies. Takeda recently announced that the product trade name for dexlansoprazole in the U.S. would be changed from KAPIDEX™ to DEXILANT. The formulation, indication and approved dosages of DEXILANT remain the same as that of KAPIDEX, which was originally approved by the U.S. Food and Drug Administration (FDA) in January 2009. After receiving reports of dispensing errors with KAPIDEX, Takeda, in coordination with the FDA, determined that in the interest of patient safety a name change would be the best way to minimize future errors.
DEXILANT is a once-daily, oral medication indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. DEXILANT is a proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication.
“Takeda’s response to this situation further demonstrates our commitment to patient safety. We are working to ensure a seamless transition from KAPIDEX to DEXILANT to mitigate any disruption to patient care,” said Tim Rudolphi, vice president of marketing at Takeda. “Over the past several months, we conducted a comprehensive communication plan to educate pharmacists, reaching out to more than 45,000 pharmacies, and other health care professionals, including all major prescription insurers and drug wholesalers, about the name change. Today we will begin expanding these efforts to also reach consumers.”
“When a name change occurs, pharmacists are often the first group of health care professionals that is impacted,” noted Marlowe Djuric Kachlic, Pharm.D., clinical assistant professor at University of Illinois at Chicago – College of Pharmacy. “The most important thing for patients, pharmacists and health care professionals to note is that DEXILANT is the same medication as KAPIDEX, with the same safety and efficacy profile.”
Individuals and health care professionals who have questions about this name change should contact Takeda at 1- 877-TAKEDA-7. Errors involving DEXILANT or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch.
About DEXILANT™ (dexlansoprazole) 30 mg and 60 mg delayed release capsules
DEXILANT is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. DEXILANT combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. DEXILANT, taken once daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Important Safety Information
DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with DEXILANT use. Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
The most commonly reported treatment-emergent adverse reactions include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). DEXILANT must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased.
DEXILANT may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
Elissa J. Johnsen
Takeda Pharmaceuticals North America