Dexilant

Common Uses

Dexilant is primarily prescribed for conditions where stomach acid causes discomfort or damage to the digestive tract. Its main uses include:

• Healing Erosive Esophagitis: It is used to treat all grades of erosive esophagitis, a condition where the lining of the esophagus becomes inflamed or damaged due to frequent exposure to stomach acid.
• Maintenance of Healed Esophagitis: After the esophagus has healed, this medication may be used to maintain that healing and provide continued relief from heartburn.
• Symptomatic GERD: It is used to treat the heartburn associated with non-erosive gastroesophageal reflux disease (GERD). This is a condition where stomach acid flows back into the esophagus, causing discomfort even if there is no visible damage to the tissue.

This medication belongs to a class of drugs known as proton pump inhibitors (PPIs). It works by decreasing the amount of acid produced in the stomach, which helps reduce symptoms and allows the esophagus time to heal.

Mechanism of Action

Dexilant works by shutting down many of the tiny pumps in the stomach lining that produce acid. These are called proton pumps. By blocking these pumps, the medication significantly lowers the level of acid in the stomach. This reduction in acid helps relieve symptoms like heartburn and allows the esophagus to heal if it has been damaged by acid reflux.

Dual Delayed Release Technology

This medication is unique because it uses a dual delayed-release delivery system. Each capsule contains two different types of granules designed to release the medicine at different times:

• The first release occurs shortly after taking the dose, providing an initial reduction in stomach acid.
• The second release happens several hours later, which helps maintain acid control for a longer period throughout the day and night.

By spreading out the release of the active ingredient, the medication provides extended relief from acid-related symptoms with a single daily dose.

Common Side Effects

The most frequently reported side effects of Dexilant are generally mild and may include:

• Diarrhea
• Stomach pain
• Nausea
• Gas
• Vomiting
• Upper respiratory tract infections, such as the common cold

Serious Side Effects

While less common, some side effects can be serious. Seek medical attention immediately for:

• Severe or persistent diarrhea that is watery or bloody
• Signs of kidney issues, such as changes in urination, blood in the urine, or unexplained weight gain
• Symptoms of low magnesium levels, including dizziness, irregular heartbeat, tremors, or muscle cramps
• New or worsening joint pain or a skin rash on the cheeks or arms that worsens in the sun
• Seizures

Using this medication for a long period may increase the risk of bone fractures in the hip, wrist, or spine, or lead to a vitamin B-12 deficiency. Seek emergency help for signs of a severe allergic reaction, such as swelling of the face or throat, hives, or difficulty breathing.

Serious Allergic Reactions

Dexilant should not be used by individuals with a known hypersensitivity to dexlansoprazole or any other proton pump inhibitor (PPI). Serious allergic reactions, including anaphylaxis and severe skin reactions, have been reported. This medication is also contraindicated for use with products containing rilpivirine.

Kidney Problems

Acute tubulointerstitial nephritis, a type of kidney inflammation, can occur at any point during treatment. This condition may progress to kidney failure if the medication is not discontinued.

Severe Diarrhea

The use of PPIs like Dexilant may increase the risk of Clostridium difficile-associated diarrhea (CDAD). This condition causes severe watery stool, stomach pain, and fever that does not improve. It is especially a concern for patients who are hospitalized.

Bone Fractures

Long-term use or high doses of Dexilant may increase the risk of fractures of the hip, wrist, or spine. This risk is generally higher in individuals who take the medication for a year or longer or those who are older.

Lupus Erythematosus

PPIs have been linked to new or worsening cases of autoimmune conditions, specifically cutaneous lupus erythematosus and systemic lupus erythematosus. Symptoms may include joint pain and a skin rash on the cheeks or arms that worsens in sunlight.

Nutritional Deficiencies

Daily use of Dexilant for long periods (typically longer than three years) may lead to a deficiency in vitamin B12 because the drug reduces the acid needed for absorption. Additionally, long-term use (usually over one year) can cause low magnesium levels, known as hypomagnesemia. This may lead to muscle spasms, seizures, or irregular heartbeats.

Masking Gastric Symptoms

Improvement in symptoms while taking Dexilant does not rule out the presence of stomach cancer. Healthcare providers may perform further testing if symptoms persist or return to ensure there is no underlying malignancy.

Fundic Gland Polyps

Long-term use of PPIs is associated with an increased risk of developing fundic gland polyps, which are small growths on the lining of the stomach. This risk increases with use longer than one year.

Drug Interactions

Dexilant can interact with several other medications. It may significantly increase the levels of methotrexate in the blood, potentially leading to toxicity. It may also affect the way warfarin works, requiring close monitoring of blood clotting times.

Pregnancy

There are no adequate and well-controlled studies of Dexilant use in pregnant women. Research in animals using high doses of dexlansoprazole did not show evidence of harm to the developing fetus or an increased risk of birth defects. However, because animal studies do not always predict human response, this medication should be used during pregnancy only if a healthcare provider determines the potential benefit outweighs the potential risk to the fetus.

Breastfeeding

It is not known whether Dexilant passes into human breast milk, how it might affect a nursing infant, or its impact on milk production. Because many medications are excreted in human milk, there is a potential for adverse reactions in nursing infants. A decision should be made whether to stop breastfeeding or stop taking the medication, taking into account the importance of the drug to the mother's health. Individuals who are breastfeeding or planning to breastfeed should discuss the potential risks and benefits with their doctor before using this medication.

Dosage Forms

Dexilant is available as a delayed-release capsule. This formulation uses a dual delayed-release technology, which is designed to release the medication in two separate phases.

The capsules are intended to be swallowed whole. However, for patients who have difficulty swallowing, the capsules may be opened and the contents can be administered by:

• Sprinkling the granules onto applesauce.
• Mixing the granules with water for administration through a gastric tube.

FDA Approval and Indications

Dexilant (dexlansoprazole) is approved by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients aged 12 years and older. It is a prescription medication indicated for the following uses:

• Healing of Erosive Esophagitis: Used for up to 8 weeks to heal all grades of erosive esophagitis (acid-related damage to the esophagus).
• Maintenance of Healed Erosive Esophagitis: Used to maintain the healing of erosive esophagitis and provide relief from heartburn.
• Symptomatic GERD: Used for up to 4 weeks to treat heartburn associated with non-erosive gastroesophageal reflux disease (GERD).

Safety Communications and Warnings

The FDA has issued several safety communications regarding the class of drugs known as proton pump inhibitors (PPIs), which includes Dexilant:

• Bone Fractures: The FDA has warned of a possible increased risk of fractures of the hip, wrist, and spine associated with PPI use. This risk is most significant in patients who receive high doses or use the medication for one year or longer.
• Clostridium difficile-Associated Diarrhea: FDA safety reviews have linked the use of PPIs to an increased risk of Clostridium difficile-associated diarrhea (CDAD), a severe form of diarrhea that does not improve.
• Lupus Erythematosus: The FDA has monitored reports of subacute cutaneous lupus erythematosus (SCLE) and systemic lupus erythematosus (SLE) associated with the use of PPIs.

Dexilant does not currently have a boxed warning or a Risk Evaluation and Mitigation Strategy (REMS) program required by the FDA.

Factors Influencing Cost

The price of Dexilant can vary based on several variables, including the pharmacy location and the specific dosage prescribed. Because it is a brand-name medication, it is often more expensive than older proton pump inhibitors.

Insurance and Generic Options

Insurance coverage is a primary factor in determining out-of-pocket costs. Many insurance providers place Dexilant on a higher cost tier or may require prior authorization, which means your doctor must provide additional information to the insurance company before the drug is covered. A generic version, dexlansoprazole, is available and is typically a more affordable option for most patients.

Financial Assistance Programs

There are several options that may help reduce the cost of this medication for eligible individuals:

• Savings Cards: The manufacturer may offer copay savings cards for patients with commercial insurance to help lower monthly out-of-pocket expenses.
• Patient Assistance: Programs may be available to provide the medication at a lower cost or for free to individuals who meet specific income requirements and lack adequate insurance coverage.
• Medicare and Medicaid: Coverage for Dexilant under government programs varies by state and specific plan. Generic versions are generally more likely to be covered at a lower cost tier than the brand-name product.