DEXILANT clinical study results

DEXILANT helps to provide full 24-hour heartburn relief and effectively maintain EE healing1

Median percentage of 24-hour heartburn-free periods of the maintenance of healed EE study1,3

Overall treatment

DEXILANT (dexlansoprazole) overall treatment

Results of a 6-month, multicenter, double-blind, placebo-controlled, randomized study of adult patients who had successfully completed an EE study and showed endoscopically confirmed healed EE. Based on crude-rate estimates, adult patients who did not have endoscopically documented relapse and prematurely discontinued were considered to have relapsed.

  • 66% of adult patients remained healed over 6 months with DEXILANT 30 mg (n=125) vs 14% with placebo (n=119; p<0.00001). Study primary endpoint.1,3

Artistic rendering of granules

Artistic rendering of granules.

DEXILANT is the only PPI with a second release of GERD medicine that arrives later in the day

Mean plasma concentration (in healthy adult subjects; day 5)1,2,4

Mean plasma concentration

Randomized, open-label, multiple-dose, crossover study (n=40) evaluating DEXILANT 60 mg capsule and lansoprazole 30 mg once daily for 5 days in healthy adult subjects.

The key to DEXILANT's two releases of medicine is its DDR technology. DDR combines two different types of granules in one pill.

Conclusions of comparative efficacy cannot be drawn from this information.

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With the DEXILANT Instant Savings Card, patients pay no more than $20* for their DEXILANT capsule prescriptions and refills.

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*Must meet Eligibility Requirements. For commercially insured patients, this savings card covers out-of-pocket expenses greater than $20, up to a maximum benefit of $55 for a 30-day prescription or $165 for a 90-day prescription. For uninsured patients, see Terms & Conditions.

Savings card cannot be used with government programs such as Medicare Part D and Medicaid.

Important Safety Information

  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis, have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis, have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
  • In adults, symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Long-term (≥ 1 year) 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 conditions being treated.
  • New onset or worsening of cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. The majority of PPI-induced lupus erythematosus cases were CLE. Avoid administration of PPIs for longer than medically indicated. Discontinue DEXILANT and refer the patient to an appropriate specialist for evaluation, if signs or symptoms of CLE or SLE occur. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., > 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment ≥ 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
  • Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT.
  • Most commonly reported adverse reactions in adults were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • The adverse reaction profile in patients age 12 to 17 years was similar to adults. The most commonly reported adverse reactions in patients age 12 to 17 years (≥ 5%) were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.
  • Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time (PT). Increases in INR and PT may lead to abnormal bleeding and even death.
  • DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil [MMF], ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF.
  • Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
  • A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment ≥ 30 days before assessing to allow gastrin levels to return to baseline.
  • Avoid concomitant use of DEXILANT with St. John's Wort or rifampin due to decreased exposure of DEXILANT.
  • No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). The use of DEXILANT is not recommended for these patients.

Indications

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated in patients ≥ age 12 years 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 in adults and up to 16 weeks in patients age 12 to 17 years
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks

Use of DEXILANT in patients age 12 to 17 years is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in patients age 12 to 17 years.

The safety and effectiveness of DEXILANT have not been established in patients < 12 years of age.

Please see full Prescribing Information, including Medication Guide for DEXILANT.

  1. DEXILANT (dexlansoprazole) prescribing information. Takeda Pharmaceuticals.
  2. Data on file. Takeda Pharmaceuticals.
  3. Metz DC, Howden CW, Perez MC, et al. Aliment Pharmacol Ther. 2009;29:742-754.
  4. Vakily M, Zhang W, Wu J, et al. Curr Med Res Opin. 2009;25:627-638.

DEXILANT and DEXILANT (with design) are trademarks of Takeda Pharmaceuticals U.S.A., Inc., registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

Dual Delayed Release is a trademark of Takeda Pharmaceuticals U.S.A., Inc. and used under license by Takeda Pharmaceuticals America, Inc.

©2017 Takeda Pharmaceuticals U.S.A., Inc.

This site is intended for use by U.S. residents only.

Important Safety Information

  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis, have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis, have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
  • In adults, symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Long-term (≥ 1 year) 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 conditions being treated.
  • New onset or worsening of cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. The majority of PPI-induced lupus erythematosus cases were CLE. Avoid administration of PPIs for longer than medically indicated. Discontinue DEXILANT and refer the patient to an appropriate specialist for evaluation, if signs or symptoms of CLE or SLE occur. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.
  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., > 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment ≥ 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
  • Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT.
  • Most commonly reported adverse reactions in adults were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • The adverse reaction profile in patients age 12 to 17 years was similar to adults. The most commonly reported adverse reactions in patients age 12 to 17 years (≥ 5%) were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.
  • Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time (PT). Increases in INR and PT may lead to abnormal bleeding and even death.
  • DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil [MMF], ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF.
  • Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
  • A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment ≥ 30 days before assessing to allow gastrin levels to return to baseline.
  • Avoid concomitant use of DEXILANT with St. John's Wort or rifampin due to decreased exposure of DEXILANT.
  • No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). The use of DEXILANT is not recommended for these patients.

Indications

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated in patients ≥ age 12 years 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 in adults and up to 16 weeks in patients age 12 to 17 years
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks

Use of DEXILANT in patients age 12 to 17 years is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in patients age 12 to 17 years.

The safety and effectiveness of DEXILANT have not been established in patients < 12 years of age.

Please see full Prescribing Information, including Medication Guide for DEXILANT.