DEXILANT is a proton pump inhibitor (PPI).

DEXILANT delayed-release capsules (DEXILANT capsules) are indicated in adults for:

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Healing of all grades of erosive esophagitis (EE). ( 1.1)

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Maintaining healing of EE and relief of heartburn. ( 1.2)

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Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3)

DEXILANT SoluTab delayed-release orally disintegrating tablets (DEXILANT SoluTab) are indicated in adults for:

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Maintaining healing of EE and relief of heartburn. ( 1.2)

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Treating heartburn associated with GERD. ( 1.3)

Recommended Adult Dosage:

Two 30 mg DEXILANT SoluTab are not interchangeable with one 60 mg DEXILANT capsule. (2.1)

DEXILANT capsules

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Healing of EE: 60 mg once daily for up to 8 weeks. ( 2.1)

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Maintenance of healed EE: 30 mg once daily for up to 6 months. ( 2.1)

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Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks. ( 2.1)

DEXILANT SoluTab

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Maintenance of healed EE: 30 mg once daily for up to 6 months. ( 2.1)

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Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks. ( 2.1)

Dosage Adjustment in Adults with Hepatic Impairment for the Healing of EE (2.2):

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Moderate hepatic impairment (Child-Pugh Class B): 30 mg once daily for up to 8 weeks of DEXILANT capsules or DEXILANT SoluTab.

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Severe hepatic Impairment (Child-Pugh Class C): use is not recommended.

Administration Instructions (2.3):

DEXILANT capsules

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Take without regard to food.

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Swallow whole; do not chew.

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See full prescribing information for alternative administration options.

DEXILANT SoluTab

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Take at least 30 minutes before a meal.

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Do not break or cut.

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Place the tablet on the tongue, allow to disintegrate and swallow without water. Do not chew microgranules.

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May also be swallowed whole with water.

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Avoid use of alcohol when taking DEXILANT SoluTab ( 7)

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See full prescribing information for alternative administration options.

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Delayed-release capsules: 30 mg and 60 mg. ( 3)

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Delayed-release orally disintegrating tablets: 30 mg. ( 3)

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Patients with known hypersensitivity to any component of the formulation. ( 4)

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Patients receiving rilpivirine-containing products. ( 4, 7)

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Gastric Malignancy: Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. ( 5.1)

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Acute Interstitial Nephritis: Observed in patients taking PPIs. ( 5.2)

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Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.3)

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Clostridium difficile Associated Diarrhea: PPI therapy may be associated with increased risk. ( 5.4)

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Bone Fracture: 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. ( 5.5)

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Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. ( 5.6)

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Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. ( 5.7, 7)

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Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT ( 5.8, 7).

Most commonly reported adverse reactions (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full prescribing information for a list of clinically important drug interactions (7).