DEXILANT IS THE ONLY PPI WITH A SECOND RELEASE OF GERD MEDICINE THAT ARRIVES LATER IN THE DAY1

Tortoise and hare image

Granule 1 begins releasing medicine within an hour of taking a DEXILANT capsule. Granule 2 provides a second release of medicine around 4-5 hours later. The clinical relevance of this information is unknown.



DEXILANT 30 mg provides effective maintenance of EE healing and heartburn relief.1



96%

DEXILANT 30 mg (n=132)

vs

29%

Placebo (n=141)

of 24-hour periods remained heartburn free in a 6‑month study.1,2

66%

DEXILANT 30 mg (n=125)

vs

14%

Placebo (n=119)

of patients remained healed over 6 months (Study primary endpoint; p<0.00001).1,2


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

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SUPPORT FOR THE PRIOR AUTHORIZATION PROCESS

79%* of commercially insured patients do not require a prior authorization for DEXILANT. But for those who do, CoverMyMeds makes PAs easy.

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Commercially insured patients are intended to show size of insured population and not imply disease prevalence or appropriate population for treatment with DEXILANT.

*Fingertip Formulary, March 2016.

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

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.
  • PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
  • Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
  • Acute interstitial nephritis has been observed in patients taking PPIs, including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Long-term (a year or longer) 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.
  • 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 at least 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 were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • 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. Increases in INR and prothrombin time 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., drugs with pH-dependent absorption such as 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 at least 30 days before assessing to allow gastrin levels to return to baseline.
  • There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
  • 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.

Indication

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed‑release capsules are indicated in adults 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

Please see Full Prescribing Information and Medication Guide for DEXILANT.

Important Safety Information

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.
  • PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
  • Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
  • Acute interstitial nephritis has been observed in patients taking PPIs, including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Long-term (a year or longer) 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.
  • 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 at least 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 were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • 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. Increases in INR and prothrombin time 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., drugs with pH-dependent absorption such as 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 at least 30 days before assessing to allow gastrin levels to return to baseline.
  • There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
  • 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.

Indication

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed‑release capsules are indicated in adults 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

Please see Full Prescribing Information and Medication Guide for DEXILANT.