Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Clinical Trials Experience
Pediatrics (additional section added)
- The safety of DEXILANT capsules was evaluated in controlled and single-arm clinical trials including 166 pediatric patients,12 to 17 years of age for the treatment of symptomatic non-erosive GERD, healing of EE, maintenance of healed EE and relief of heartburn. The adverse reaction profile was similar to that of adults. The most common adverse reactions that occurred in ≥ 5% of patients were headache, abdominal pain, diarrhea, nasopharyngitis and oropharyngeal pain.
Other Adverse Reactions (additional subheading added)
- See the full prescribing information for lansoprazole for other adverse reactions not observed with DEXILANT.
USE IN SPECIFIC POPULATIONS
Pediatric Use (additional information below)
- The safety and effectiveness of DEXILANT capsules have been established in pediatric patients 12 to 17 years of age for the healing of all grades of EE. The safety and effectiveness of DEXILANT capsules and DEXILANT SoluTab have been established in pediatric patients 12 to 17 years of age for the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD.
- Use of DEXILANT in this age group is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years of age.
- The adverse reaction profile in patients 12 to 17 years of age was similar to adults.
- The safety and effectiveness of DEXILANT have not been established in pediatric patients less than 12 years of age.
Hepatic Impairment (addition of adult to sentence)
- In a study of adult patients…
What is DEXILANT? (updated)
- DEXILANT delayed-release capsules (DEXILANT capsules) are used in adults people 12 years of age and older:
- for up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of erosive esophagitis and relief of heartburn
- DEXILANT SoluTab delayed-release orally disintegrating tablets (DEXILANT SoluTab) is used in people 12 years of age and older:
- for up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of EE and relief of heartburn
- It is not known if DEXILANT is safe and effective in children under 12 years of age.
What are the possible side effects of DEXILANT?
DEXILANT may cause serious side effects, including:
- The most common side effects of DEXILANT in adults include: (updated sentence with new words underlined)
- The most common side effects in children 12 to 17 years of age include: (addition of section)
- stomach pain
- pain or swelling (inflammation) in your mouth, nose or throat
- … Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
Cyanocobalamin (vitamin B12) Deficiency
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
5 WARNINGS AND PRECAUTIONS
5.4 Concomitant Use of DEXILANT with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7.5)].
7 DRUG INTERACTIONS
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate .....
- section added....