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Dexilant

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Dexilant and Dexilant SoluTabs




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of DEXILANT capsules was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least six months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on DEXILANT 30 mg capsules, 2218 patients on DEXILANT 60 mg capsules, and 1363 patients on lansoprazole 30 mg once daily.

Common Adverse Reactions

The most common adverse reactions ( ≥ 2%) that occurred at a higher incidence for DEXILANT capsules than placebo in the controlled studies are presented in Table 3.

Table 3: Common Adverse Reactions in Controlled Studies

Adverse Reaction Placebo
(N=896) %
DEXILANT 30 mg capsules
(N=455) %
DEXILANT 60 mg capsules
(N=2218) %
DEXILANT capsules Total
(N=2621) %
Lansoprazole 30 mg
(N=1363) %
Diarrhea 2.9 5.1 4.7 4.8 3.2
Abdominal Pain 3.5 3.5 4.0 4.0 2.6
Nausea 2.6 3.3 2.8 2.9 1.8
Upper Respiratory Tract Infection 0.8 2.9 1.7 1.9 0.8
Vomiting 0.8 2.2 1.4 1.6 1.1
Flatulence 0.6 2.6 1.4 1.6 1.2

Adverse Reactions Resulting In Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from DEXILANT therapy was diarrhea (0.7%).

Less Common Adverse Reactions

Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system:

Blood and Lymphatic System Disorders: anemia, lymphadenopathy

Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia

Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo

Endocrine Disorders: goiter

Eye Disorders: eye irritation, eye swelling

Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett's esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage, retching

General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia

Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly

Immune System Disorders: hypersensitivity

Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection

Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn

Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase

Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia

Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia

Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia

Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes

Renal and Urinary Disorders: dysuria, micturition urgency

Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder

Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, respiratory tract congestion, sore throat

Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritus, rash, skin lesion, urticaria

Vascular Disorders: deep vein thrombosis, hot flush, hypertension

Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to DEXILANT by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, bursitis, central obesity, cholecystitis acute, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gout, herpes zoster, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, rectal tenesmus, restless legs syndrome, somnolence, tonsillitis.

See the full prescribing information for lansoprazole for other adverse reactions not observed with DEXILANT.

Postmarketing Experience

The following adverse reactions have been identified during post-approval of DEXILANT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura

Ear and Labyrinth Disorders: deafness

Eye Disorders: blurred vision

Gastrointestinal Disorders: oral edema, pancreatitis

General Disorders and Administration Site Conditions: facial edema

Hepatobiliary Disorders: drug-induced hepatitis

Immune System Disorders: anaphylactic shock (requiring emergency intervention), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Infections and Infestations: Clostridium Difficile associated diarrhea

Metabolism and Nutrition Disorders: hypomagnesemia, hyponatremia

Musculoskeletal System Disorders: bone fracture

Nervous System Disorders: cerebrovascular accident, transient ischemic attack

Renal and Urinary Disorders: acute renal failure

Respiratory, Thoracic and Mediastinal Disorders: pharyngeal edema, throat tightness

Skin and Subcutaneous Tissue Disorders: generalized rash, leukocytoclastic vasculitis

Read the Dexilant and Dexilant SoluTabs (dexlansoprazole capsules and tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Tables 4 and 5 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with DEXILANT and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with DEXILANT and Interactions with Diagnostics

Antiretrovirals
Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with dexlansoprazole may reduce antiviral effect and promote the development of drug resistance.
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with dexlansoprazole may increase toxicity of the antiretroviral drugs.
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with dexlansoprazole.
Intervention: Rilpivirine-containing products: Concomitant use with DEXILANT is contraindicated [see CONTRAINDICATIONS]. See prescribing information.
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with DEXILANT. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities.
Other antiretrovirals: See prescribing information.
Warfarin
Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Methotrexate
Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see WARNINGS AND PRECAUTIONS].
Intervention: A temporary withdrawal of DEXILANT may be considered in some patients receiving high-dose methotrexate.
Digoxin
Clinical Impact: Potential for increased exposure of digoxin.
Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenoloate mofetil, ketoconazole/itraconazole)
Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Intervention: Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving DEXILANT and MMF. Use DEXILANT with caution in transplant patients receiving MMF.
See the prescribing information for other drugs dependent on gastric pH for absorption.
Tacrolimus
Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.
Interactions with Investigations of Neuroendocrine Tumors
Clinical Impact: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Intervention: Temporarily stop DEXILANT 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.
Interaction with Secretin Stimulation Test
Clinical Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.
Intervention: Temporarily stop DEXILANT treatment at least 30 days before assessing to allow gastrin levels to return to baseline [see CLINICAL PHARMACOLOGY].
False Positive Urine Tests for THC
Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
Intervention: An alternative confirmatory method should be considered to verify positive results.

Table 5: Clinically Relevant Interactions Affecting DEXILANT When Co-Administered with Other Drugs

CYP2C19 or CYP3A4 Inducers
Clinical Impact: Decreased exposure of dexlansoprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY].
Intervention: St. John’s Wort, rifampin: Avoid concomitant use with DEXILANT. Ritonavir-containing products: See prescribing information.
CYP2C19 or CYP3A4 Inhibitors
Clinical Impact: Increased exposure of dexlansoprazole is expected when used concomitantly with strong inhibitors [see CLINICAL PHARMACOLOGY].
Intervention: Voriconazole: See prescribing information.
Alcohol and DEXILANT SoluTab
Clinical Impact: Alcohol may modify the release rate of dexlansoprazole from DEXILANT SoluTab, possibly leading to decreased efficacy.
Intervention: Avoid alcoholic beverages when taking DEXILANT SoluTab [see DOSAGE AND ADMINISTRATION].

Read the Dexilant and Dexilant SoluTabs Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/7/2016

Side Effects
Interactions

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