In most patients, treatment of hypomagnesemia (and hypomagnesemia associated hypocalcemia and/or hypokalemia) required magnesium replacement and discontinuation of the PPI. , diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
See 8 ADVERSE REACTIONS. The chronic use of PPIs may lead to hypomagnesemia.
Cyanocobalamin (Vitamin B12) Deficiency:
The prolonged use of PPIs may impair the absorption of protein-bound Vitamin B12 and may contribute to the development of cyanocobalamin (Vitamin B12) deficiency. Gastrointestinal Long-term use of DEXILANT is associated with an increased risk of fundic gland polyps, especially beyond one year.
See 8 ADVERSE REACTIONS. Most fundic gland polyps are asymptomatic. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Genitourinary Testicular interstitial cell adenoma occurred in 1 of 30 rats treated with 50 mg/kg/day of lansoprazole (13 times the recommended human dose based on body surface area) in a one-year toxicity study.
See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity. These changes are associated with endocrine alterations which have not been, to date, observed in humans. Hepatic/Biliary/Pancreatic No dosage adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
A maximum daily dose of 30 mg should be considered for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions.
Immune Severe Cutaneous Adverse Reactions:
Severe cutaneous adverse reactions (SCARs), including Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and erythema multiforme have been reported in association with the use of PPIs.
Discontinue dexlansoprazole at the first signs or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation. At the time of prescription, patients should be informed of the signs and symptoms, and advised to monitor closely for skin reactions.
5 Post-Market Drug Reactions.
Subacute cutaneous lupus erythematosus:
Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of PPIs. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping DEXILANT.
The occurrence of SCLE with previous PPI treatment may increase the risk of SCLE with other PPIs. 5 Post-Market Adverse Drug Reactions. Monitoring and Laboratory Tests During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity.
Increased CgA levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, DEXILANT treatment should be stopped 14 days before CgA measurements. 4 Drug-Drug Interactions.
Musculoskeletal 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 condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. Renal No dosage adjustment is necessary for patients with renal impairment. 3 Pharmacokinetics, Special Populations and Conditions. 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women with DEXILANT.
Exposure in clinical trials was very limited. DEXILANT should not be administered to pregnant women unless the expected benefits outweigh the potential risks. See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology.
2 Breast-feeding It is not known whether DEXILANT (dexlansoprazole) is excreted in human milk. However, lansoprazole (the racemate) and its metabolites are excreted in the milk of rats. As many drugs are excreted in human milk, DEXILANT should not be given to nursing mothers unless its use is considered essential.
In this case, nursing should be avoided. 3 Pediatrics Pediatrics (<12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of DEXILANT in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use in children under 12 years of age.
DEXILANT should not be used in pediatric patients less than one year of age because lansoprazole (the racemic mixture) was not effective for the treatment of symptomatic GERD in a multicenter, double- blind controlled trial. In addition, toxicology studies with lansoprazole have shown heart valve thickening and bone changes in juvenile rats.
See 16 NON-CLINICAL TOXICOLOGY, Juvenile Animal Toxicity Data.
Pediatrics (12 to 17 years of age):
DEXILANT is indicated for adolescents 12 to 17 years of age, and is supported by evidence from adequate and well-controlled studies of dexlansoprazole in adults, and by additional efficacy, safety and pharmacokinetic data in adolescents 12 to 17 years of age for the treatment of heartburn associated with symptomatic non-erosive GERD, […]