Deerfield, Ill., (March 4, 2010) –Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.
After receiving reports of dispensing errors between KAPIDEX and the products Casodex® (bicalutamide) and Kadian® (morphine sulfate extended-release), Takeda, in coordination with the U.S. Food and Drug Administration (FDA), determined that, in the interest of patient safety, a name change would be the best way to minimize future medication errors with KAPIDEX.
It is important to stress that the formulation, indication and approved dosages of DEXILANT will remain the same as KAPIDEX. Markings on the capsules will not change and their appearance will be identical to those marked under the KAPIDEX trade name. DEXILANT will have a new National Drug Code (NDC) number associated with the product. Takeda anticipates that the newly named product DEXILANT will be available toward the end of April 2010.
“Takeda’s first priority is patient safety, which is why we initiated a widespread communications campaign to inform healthcare professionals and pharmacists as soon as we learned about the potential for confusion,” said Robert Spanheimer, M.D., vice president of medical and scientific affairs at Takeda. “Recently, through discussions with the FDA, we agreed that the best way to minimize these dispensing errors was to change the trade name of dexlansoprazole to DEXILANT.”
Takeda is currently working with the FDA to make this change and will conduct an extensive communications campaign to alert both patients and healthcare professionals of DEXILANT. Individuals and healthcare professionals who have questions about this name change should contact Takeda at 1-877- TAKEDA-7.
“New medication names are extensively screened by Takeda prior to adoption to minimize the possibility of confusion once a drug is on the market. The FDA also conducts independent research to further minimize the risk of name confusion prior to acceptance and approval of a product brand name,” said Dean Sundberg, senior vice president of regulatory affairs at Takeda. “Once marketed, however, instances of name confusion occasionally emerge.”
Errors involving DEXILANT or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch.
About KAPIDEX™ (dexlansoprazole) 30 mg and 60 mg delayed release capsules
KAPIDEX 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. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, 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
KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy.
The most commonly reported treatment-emergent adverse reactions (≥2%) include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). KAPIDEX must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased.
KAPIDEX 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.
Please visit the KAPIDEX Web site at www.KAPIDEX.com, and click here for full prescribing information.
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