"July 6, 2015 -- About 21 million Americans have used prescription heartburn medications called proton pump inhibitors to help ease pain and discomfort after they eat. But does that help come at a price?
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Dexilant and Dexilant SoluTabs
Presence Of Gastric Malignancy
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue DEXILANT if acute interstitial nephritis develops [see CONTRAINDICATIONS].
Cyanocobalamin (Vitamin B-12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with DEXILANT.
Clostridium Difficile Associated Diarrhea
Published observational studies suggest that PPI therapy like DEXILANT 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.
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. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS].
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see ADVERSE REACTIONS].
Interactions With Investigations For Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
Interaction With Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) 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].
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
- Hypersensitivity Reactions [see CONTRAINDICATIONS].
- Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS].
- Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS].
- Clostridium Difficile Associated Diarrhea [see WARNINGS AND PRECAUTIONS].
- Bone Fracture [see WARNINGS AND PRECAUTIONS].
- Hypomagnesemia [see WARNINGS AND PRECAUTIONS].
Advise patients to report to their healthcare provider if they are taking high-dose methotrexate [see WARNINGS AND PRECAUTIONS].
Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
- Take without regard to food.
- Swallow whole; do not chew.
- Can be opened and sprinkled on applesauce for patients who have trouble swallowing the capsule.
- Alternatively, the capsule can be administered with water via oral syringe or NG tube.
- Take at least 30 minutes before a meal.
- Do not break or cut.
- Place the tablet on the tongue, allow it to disintegrate, and swallow the microgranules without water. Do not chew the microgranules.
- May also be swallowed whole with water.
- Avoid use of alcohol when taking DEXILANT SoluTab [see DRUG INTERACTIONS].
- Alternatively, the tablet can be administered with water via oral syringe or NG tube.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two 24-month carcinogenicity studies, Sprague-Dawley rats were treated orally with lansoprazole at doses of 5 to 150 mg/kg/day, about 1 to 40 times the exposure on a body surface (mg/m²) basis of a 50 kg person of average height [1.46 m² body surface area (BSA)] given the recommended human dose of lansoprazole 30 mg/day.
In rats, lansoprazole also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human lansoprazole dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.
In a 24 month carcinogenicity study, CD-1 mice were treated orally with lansoprazole doses of 15 to 600 mg/kg/day, 2 to 80 times the recommended human lansoprazole dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg lansoprazole/kg/day (40 to 80 times the recommended human lansoprazole dose based on BSA) and female mice treated with 150 to 600 mg lansoprazole/kg/day (20 to 80 times the recommended human lansoprazole dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human lansoprazole dose based on BSA).
A 26 week p53 (+/-) transgenic mouse carcinogenicity study of lansoprazole was not positive.
Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay. Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test or the rat bone marrow cell chromosomal aberration test.
Dexlansoprazole was positive in the Ames test and in the in vitro chromosome aberration test using Chinese hamster lung cells. Dexlansoprazole was negative in the in vivo mouse micronucleus test.
The potential effects of dexlansoprazole on fertility and reproductive performance were assessed using lansoprazole studies. Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.
Use In Specific Populations
There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral dexlansoprazole to rabbits during organogenesis at doses up to 9 times the maximum recommended human dose (MRHD) (based on body surface area) or with administration of oral lansoprazole to rats and rabbits during organogenesis at doses up to 40 and 16 times the MRHD (based on body surface area), respectively [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
An embryo-fetal development study conducted in rabbits at oral dexlansoprazole doses up to 30 mg/kg/day (approximately 9 times the maximum recommended human dexlansoprazole dose [60 mg/day] based on body surface area) during organogenesis showed no effects on fetuses due to dexlansoprazole. In addition, embryo-fetal development studies performed in rats with oral lansoprazole at doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on body surface area) during organogenesis and in rabbits with oral lansoprazole at doses up to 30 mg/kg/day (16 times the recommended human lansoprazole dose based on body surface area) during organogenesis revealed no effects on fetuses due to lansoprazole.
There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. However, lansoprazole and its metabolites are present in rat milk [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXILANT and any potential adverse effects on the breastfed child from DEXILANT or from the underlying maternal condition.
When [14C] lansoprazole was administered orally at 2 mg/kg to lactating rats 14 days after parturition, milk collected at 0.5, 2 and 6 hours after the lansoprazole dose contained 2- to 6-fold higher concentrations of radioactivity than plasma. Almost all of the radioactivity was determined to be from lansoprazole metabolites.
Safety and effectiveness of DEXILANT have not been established in pediatric patients.
The use of DEXILANT is not recommended for symptomatic non-erosive GERD in pediatric patients less than 1 year of age because studies in this class of drugs have not demonstrated efficacy.
Of the total number of patients (n=4548) in clinical studies of DEXILANT, 11% of patients were aged 65 years and over, while 2% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see CLINICAL PHARMACOLOGY].
No dosage adjustment for DEXILANT capsules or DEXILANT SoluTab is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
In a study of patients with moderate hepatic impairment (Child-Pugh Class B) who received a single 60 mg DEXILANT capsule, there was a significant increase in systemic exposure of dexlansoprazole compared to healthy subjects with normal hepatic function [see CLINICAL PHARMACOLOGY]. Therefore, for adult patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage of DEXILANT capsules or DEXILANT SoluTab for the healing of EE is 30 mg once daily for up to 8 weeks [see DOSAGE AND ADMINISTRATION].
No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); the use of DEXILANT capsules or DEXILANT SoluTab is not recommended for these patients [see DOSAGE AND ADMINISTRATION].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2016
Additional Dexilant and Dexilant SoluTabs Information
- Dexilant and Dexilant SoluTabs Drug Interactions Center: dexlansoprazole oral
- Dexilant and Dexilant SoluTabs Side Effects Center
- Dexilant and Dexilant SoluTabs in detail including Side Effects and Drug Images
- Dexilant and Dexilant SoluTabs Overview including Precautions
- Dexilant and Dexilant SoluTabs FDA Approved Prescribing Information including Dosage
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