dexlansoprazole (Rx)

Brand and Other Names:Dexilant, Kapidex, more...Dexilant SoluTab
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

delayed-release capsule

  • 30mg
  • 60mg

delayed-release oral disintegrating tablet (ODT)

  • 30mg

Erosive Esophagitis

Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE

ODT: Indicated for maintaining healing of EE

Healing (capsule): 60 mg PO qDay for up to 8 weeks

Maintenance (capsule or ODT): 30 mg PO qDay for up to 6 months

Gastroesophageal Reflux Disease

Indicated for treating heartburn associated with symptomatic nonerosive GERD

Capsule or ODT: 30 mg PO qDay for 4 weeks

Dosage Modifications

Hepatic impairment

  • Milde (Child-Pugh A): Dose adjustment not necessary
  • Moderate (Child-Pugh B): Not to exceed 30 mg/day
  • Severe (Child-Pugh C): Not recommended

Dosage Forms & Strengths

delayed-release capsule

  • 30mg
  • 60mg

delayed-release oral disintegrating tablet (ODT)

  • 30mg

Erosive Esophagitis

<12 years

  • Safety and efficacy not established

>12 years

  • Capsule: Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE
  • ODT: Indicated for maintaining healing of EE
  • Healing (capsule): 60 mg PO qDay for up to 8 weeks
  • Maintenance (capsule or ODT): 30 mg PO qDay for up to 6 months

Gastroesophageal Reflux Disease

<12 years

  • Safety and efficacy not established

>12 years

  • Indicated for treating heartburn associated with symptomatic nonerosive GERD
  • Capsule or ODT: 30 mg PO qDay for 4 weeks
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Interactions

Interaction Checker

and dexlansoprazole

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Diarrhea (5%)

            Abdominal pain (4%)

            Nausea (3%)

            URI (2-3%)

            Vomiting (1-2%)

            Flatulence (1%)

            <1% (Selected)

            Arrhythmia

            Bradycardia

            Barrett's esophagus

            DVT

            Dyspnea

            Hepatomegaly

            Hypertension

            Paresthesia

            Rectal hemorrhage

            Vulvovaginal infection

            Postmarketing Reports

            Blurred vision

            Oral edema

            Facial edema

            Anaphylactic shock (requiring emergency intervention)

            Stevens-Johnsons syndrome

            Toxic epidermal necrolysis (sometimes fatal)

            Pharyngeal edema, throat tightness

            Generalized rash

            Leukocytoclastic vasculitis

            Bone fracture

            Cutaneous and systemic lupus erythematosus

            Cyanocobalamin (vitamin B-12) deficiency

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            Warnings

            Contraindications

            Hypersensitivity reactions, including anaphylaxis and acute interstitial nephritis reported

            PPIs are contraindicated with rilpivirine-containing products

            Cautions

            Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

            May interfere with absorption of drugs for which pH is a determinant of oral bioavailability (eg, atazanavir)

            Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

            Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4- 12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

            Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy

            Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

            Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

            Therapy increases risk of Salmonella, Campylobacter, and other infections

            Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically

            Brand name changed from Kapidex to Dexilant

            Daily long-term use (eg, >3 yr) may lead to malabsorption or a deficiency of cyanocobalamin

            Acute interstitial nephritis reported in patients taking proton pump inhibitors (see Contraindications)

            Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors; temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high

            May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of dexlansoprazole therapy with high dose methotrexate administration

            Significant increase in systemic exposure of dexlansoprazole reported in patients with moderate hepatic impairment (Child-Pugh Class B) who received a single dose of 60 mg compared to healthy subjects with normal hepatic function

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Not known whether distributed into breast milk; discontinue nursing or drug

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            R-enantiomer of lansoprazole; PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in blockage of acid secretion

            Dual release formulation

            Absorption

            Peak plasma time: 1-2 hr and 4-5 hr (dual release)

            Distribution

            Protein bound: >96%

            Vd: 40.3 L

            Metabolism

            Hydroxylation mainly by CYP2C19 and oxidation to sulfone by CYP3A4

            Elimination

            Half-life elimination: 1-2 hr

            Excretion: Feces (48% as metabolites), urine (51% as metabolites)

            Pharmacogenomics

            Extensively metabolized in the liver by oxidation and reduction; oxidative metabolites are formed mainly by CYP2C19

            Dexlansoprazole is the major circulating component regardless of CYP2C19 allele status

            In extensive (*1/*1) and intermediate (*1/mutant) CYP2C19 metabolizers, 5-hydroxy dexlansoprazole is the major metabolite

            In CYP2C19 poor metabolizers (mutant/mutant), dexlansoprazole sulfone is the major plasma metabolite (because of an increase in the alternate metabolic pathway via CYP3A4)

            Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers

            Intermediate metabolizers: Mean dexlansoprazole Cmax and AUC values were up to 2 times higher than they were in extensive metabolizers

            Poor metabolizers: Mean Cmax was up to 4 times higher and mean AUC was up to 12 times higher than they were in extensive metabolizers

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            Administration

            Oral Administration

            Capsule

            • May take with or without food
            • Swallow whole; do not chew
            • May sprinkle capsule contents on applesauce
              • 1. Place 1 TBSP of applesauce into a clean container
              • 2. Open capsule and sprinkle intact granules on applesauce
              • 3. Swallow applesauce and granules immediately, do not chew granules
              • 4. Do not save applesauce and granules for later use
            • Preparing capsule contents with water in oral syringe
              • 1. Open the capsule and empty the granules into a clean container with 20 mL of water
              • 2. Withdraw the entire mixture into a syringe
              • 3. Gently swirl the syringe in order to keep granules from settling
              • 4. Administer the mixture immediately into the mouth; do not save the water and granule mixture for later use
              • 5. Refill the syringe with 10 mL of water, swirl gently, and administer
              • 6. Refill the syringe again with 10 mL of water, swirl gently, and administer
            • Preparing capsule contents with water for NG tube administration
              • NG tube (≥16 French)
              • 1. Open the capsule and empty the granules into a clean container with 20 mL of water
              • 2. Withdraw the entire mixture into a catheter-tip syringe
              • 3. Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach; do not save the water and granule mixture for later use
              • 4. Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube
              • 5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer

            Oral disintegrating tablet

            • Take at least 30 minutes before a meal
            • Do not break or cut
            • Place the tablet on the tongue, allow to disintegrate and swallow without water
            • Do not chew microgranules
            • May also be swallowed whole with water
            • Avoid use of alcohol
            • ODT with water in oral syringe
              • 1. Place one tablet in an oral syringe and draw up 20 mL of water
              • 2. Swirl gently to allow for a quick dispersal
              • 3. After the tablet has dispersed, administer the contents immediately into the mouth; do not save the water and microgranule mixture for later use
              • 4. Refill the syringe with approximately 10 mL of water, swirl gently, and administer any remaining contents
              • 5. Refill the syringe again with approximately 10 mL of water, swirl gently, and administer any remaining contents
            • Preparing ODT with water for NG tube administration
              • 1. Place one tablet in a catheter-tip syringe and draw up 20 mL of water
              • 2. Shake gently to allow for a quick dispersal
              • 3. After the tablet has dispersed, swirl the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach; do not save the water and microgranule mixture for later use
              • 4. Refill the catheter-tip syringe with approximately 10 mL of water, shake gently, and flush the tube
              • 5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer

            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 2 doses at one time to make up for a missed dose
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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