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ABOUT DEXILANT

DUAL DELAYED RELEASE (DDR) FORMULATION

DEXILANT is the first and only PPI with a Dual Delayed Release (DDR) formulation, which combines 2 types of enteric-coated granules in one pill. The clinical relevance of this statement is unknown.

DEXILANT capsules contain 2 types of granules1 - Granule 1 begins releasing drug within an hour of dosing - Granule 2 provides a second release of drug with another peak concentration several hours after dosing

DEXILANT WORKS A SECOND SHIFT TO HELP SHUT DOWN ACID PUMPS

The DDR formulation provides a second release of drug. The two releases of medicine result in a dexlansoprazole plasma concentration-time profile with two distinct peaks. The first peak occurs 1–2 hours after dosing, while the second peak occurs within 4–5 hours.1

Conclusions of comparative efficacy cannot be drawn from this information.

The Dual Delayed Release (DDR) formulation provides a second release of drug

Mean plasma concentration (in healthy subjects; day 5)1

DEXILANT effectively maintains intragastric pH >4

% time intragastic pH >4 (in healthy subjects; day 5; mean)1,2 - 24 Hours DEXILANT 60 mg 71% (n=20) Lansoprazole 30 mg 60% (n=23)

The effects of DEXILANT 60 mg or lansoprazole 30 mg once daily for 5 days on a 24-hour intragastric pH in healthy subjects in a multiple-dose crossover study.

THE CORRELATION OF THESE DATA TO CLINICAL OUTCOMES HAS NOT BEEN DIRECTLY ESTABLISHED.

Reference: 1. DEXILANT (dexlansoprazole) package insert, Takeda Pharmaceuticals America, Inc.

DEXILANT is indicated for:

  • 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

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.
  • 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. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
  • 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%).
  • Do not co-administer atazanavir with DEXILANT because atazanavir systemic concentrations may be substantially decreased. DEXILANT may interfere with 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 see the full Prescribing Information for DEXILANT.

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