Dexlansoprazole

Dexlansoprazole may cause serious side effects, including:

• See “Drug Precautions”
• Vitamin B-12 deficiency. Dexlansoprazole reduces the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B-12 properly. Talk with your doctor about the possibility of Vitamin B-12 deficiency if you have been on dexlansoprazole for a long time (more than 3 years). 
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking dexlansoprazole, or during treatment, if you will be taking dexlansoprazole for a long period of time.

The most common side effects of dexlansoprazole include:

• diarrhea
• stomach pain
• nausea
• common cold
• vomiting
• gas

The most common side effects of dexlansoprazole in children 12 to 17 years of age include: 

• headache 
• stomach pain 
• diarrhea 
• pain or swelling (inflammation) in your mouth, nose or throat 

Serious allergic reactions may occur. Tell your doctor if you get any of the following symptoms with dexlansoprazole:

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop dexlansoprazole if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of dexlansoprazole. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dexlansoprazole may affect how other medicines work, and other medicines may affect how dexlansoprazole works.

Especially tell your doctor if you take:

• an antibiotic that contains ampicillin
• atazanavir (Reyataz)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• methotrexate
• erlotinib
• medications that contain iron including Feosol, Ferra-TD, Fer-in-Sol, and ferrous sulfate

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dexlansoprazole there are no specific foods that you must exclude from your diet when receiving dexlansoprazole.

Dexlansoprazole orally disintegrating tablets should not be taken with alcohol. Alcohol may may affect how dexlansoprazole orally disintegrating tablets works. 

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if dexlansoprazole passes into your breast milk. You and your doctor should decide if you will take dexlansoprazole or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take dexlansoprazole.

Dexlansoprazole Dosing Recommendations for Erosive Esophagitis (EE)

The recommended dexlansoprazole dosage to heal erosive esophagitis is 60 mg once daily for up to eight weeks.

After erosive esophagitis is healed, the recommended dose is dexlansoprazole 30 mg once daily. 

Dexlansoprazole Dosing Recommendations for Heartburn related to Gastroesophageal Reflux Disease (GERD)

Dexlansoprazole 30 mg once daily for four weeks.

Usual Adult Dose for Erosive Esophagitis:

Healing of Erosive Esophagitis (EE): 60 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day
-Duration of therapy: Up to 6 months

Comments:
-Patients may be given maintenance doses for the relief of heartburn.
-Controlled studies for maintenance therapy did not extend beyond 6 months.

Uses:
-Healing of all grades of EE
-Maintenance of healed EE
-Relief of heartburn

Usual Adult Dose for Gastroesophageal Reflux Disease:

30 mg orally once a day
-Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)

Usual Pediatric Dose for Erosive Esophagitis:

12 years and older:
Healing of EE: 60 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day
-Duration of therapy: Up to 6 months

Comments:
-Patients may be given maintenance doses for the relief of heartburn.
-Controlled studies of maintenance therapy did not extend beyond 16 weeks.

Uses:
-Healing of all grades of EE
-Maintenance of healed EE
-Relief of heartburn

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

12 years and older: 30 mg orally once a day
-Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive GERD

Contraindications

• Known hypersensitivity to dexlansoprazole or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome) reported.1

Gastric Malignancy

Response to dexlansoprazole therapy does not preclude presence of occult gastric neoplasm.1

Clostridium difficile Infection

Proton-pump inhibitors associated with possible increased (1.4–2.75 times) risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis).335 336 339 340 Many patients also had other risk factors for CDAD.335 May be severe; colectomy and, rarely, death reported.335

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.335

Consider CDAD if persistent diarrhea develops and manage accordingly; initiate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.335 336

Bone Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.1 9 300 301 302 303 304 305 Magnitude of risk is unclear;9 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.1 9 301 303 305 307

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients’ bone health according to current standards of care.1 9 303 305 307

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, reported rarely in patients receiving long-term therapy (≥3 months or, in most cases, >1 year) with proton-pump inhibitors, including dexlansoprazole.1 317 318 319 320 321 322 323 324 325 326 327 328 329 330 Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval.1 318 319 321 322 323 325 327 328 329 Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur.319 320 321 325 330 Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor.1 317 319 321 322 323 324 325 326 327 330 Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.327

In patients expected to receive long-term proton-pump inhibitor therapy or in patients currently receiving digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), consider measuring serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.1 319 326 327 328 330

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).7 8

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling of Kapidex (former trade name for dexlansoprazole) and Casodex (trade name for bicalutamide, a nonsteroidal antiandrogenic antineoplastic agent220 ) or Kadian (a trade name for morphine sulfate, an opiate agonist analgesic221 ) may result in errors.217 218 219 223 In April 2010, manufacturer changed trade name for dexlansoprazole from Kapidex to Dexilant to avoid future errors.1 217

Also be aware of potential for Kapidex to be confused with Capadex (fixed-combination propoxyphene/acetaminophen preparation that is available via the Internet and is marketed in certain other countries [e.g., Australia]).216 219

Specific Populations

Category B.1

Not known whether dexlansoprazole is distributed into milk; however, lansoprazole and its metabolites are distributed into milk in rats.1 Discontinue nursing or the drug.1

Safety and efficacy not established in children <18 years of age.1

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity of some older patients cannot be ruled out.1

Systemic exposure to dexlansoprazole is increased approximately twofold in individuals with moderate hepatic impairment.1 Not studied in severe hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea,1 2 4 abdominal pain,1 2 nausea,1 2 upper respiratory infection,1 2 4 vomiting,1 2 flatulence.1 2

• Dexlansoprazole is the R-isomer of lansoprazole (a racemic mixture of R- and S-isomers).1 5 22 Both isomers inhibit hydrogen-potassium ATPase, but plasma clearance of dexlansoprazole is slower than that of S-lansoprazole.25 32

• Proton-pump inhibitors inhibit basal and stimulated gastric acid secretion.24

• Dexlansoprazole binds to and inactivates hydrogen-potassium ATPase (proton, hydrogen, or acid pump) in gastric parietal cells, blocking the final step in secretion of hydrochloric acid; results in potent, long-lasting inhibition of gastric acid secretion.1 22

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if dexlansoprazole is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not take dexlansoprazole if you are also using products that contain rilpivirine (Complera®, Edurant®).

dexlansoprazole may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using dexlansoprazole.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after taking dexlansoprazole. These could be symptoms of acute interstitial nephritis.

Taking dexlansoprazole for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking dexlansoprazole.

Dexlansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of dexlansoprazole, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

dexlansoprazole may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking dexlansoprazole for more than 1 year, or if you are taking dexlansoprazole together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Do not stop taking dexlansoprazole without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking dexlansoprazole. The results of some tests may be affected by dexlansoprazole.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

• Dexilant SoluTab
• Kapidex
• TAK-390MR

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, the pharmacokinetics of dexlansoprazole are not expected to be altered in patients with renal impairment.

Hemodialysis: Dexlansoprazole is not expected to be removed by hemodialysis.