Dexlansoprazole - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response with dexlansoprazole delayed-release capsules does not preclude the presence of gastric malignancy.

Consider additional follow-up and diagnostic testing.

Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.

Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk.

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.

Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue dexlansoprazole delayed-release capsules and refer to specialist for evaluation.

Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.

Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs.

Interactions with 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. ( 5.9 , 7 ) 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 dexlansoprazole delayed-release capsules. ( 5.10 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond 1 year.

Use the shortest duration of therapy.

Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age : Dexlansoprazole delayed-release capsules are not recommended in pediatric patients less than 2 years of age. ( 5.12 , 8.4 ) 5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with dexlansoprazole delayed-release capsules does not preclude the presence of gastric malignancy.

Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.

In older patients, also consider an endoscopy.

5.2 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.

Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia).

In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue dexlansoprazole delayed-release capsules and evaluate patients with suspected acute TIN [see Contraindications ] .

5.3 Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like dexlansoprazole delayed-release capsules may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients.

This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ] .

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.4 Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.

The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated.