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SAFETY INFORMATION
DEXILANT WORKS WITH A SAFETY AND TOLERABILITY PROFILE SIMILAR TO LANSOPRAZOLE
In studies of nearly 6000 patients, DEXILANT showed safety and tolerability similar to lansoprazole and placebo*
| Incidence of adverse reactions in controlled studies1 |
| Diarrhea |
2.9% |
5.1% |
4.7% |
4.8% |
3.2% |
| Abdominal pain |
3.5% |
3.5% |
4.0% |
4.0% |
2.6% |
| Nausea |
2.6% |
3.3% |
2.8% |
2.9% |
1.8% |
Upper respiratory
tract infection |
0.8% |
2.9% |
1.7% |
1.9% |
0.8% |
| Vomiting |
0.8% |
2.2% |
1.4% |
1.6% |
1.1% |
| Flatulence |
0.6% |
2.6% |
1.4% |
1.6% |
1.2% |
*Includes patients who completed trials for higher DEXILANT doses2
- 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.
- 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.
See the full Prescribing Information for more detail.
References: 1. DEXILANT (dexlansoprazole) package insert, Takeda Pharmaceuticals America, Inc. 2. Data on file. Takeda Pharmaceuticals North 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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