Lialda

Treatment of Ulcerative Colitis

Lialda is primarily used to treat the symptoms of mild to moderate ulcerative colitis, a chronic inflammatory bowel disease. It works by acting directly on the lining of the colon to reduce inflammation, which helps alleviate symptoms such as:

• Diarrhea
• Rectal bleeding
• Stomach pain or cramping

Maintenance of Remission

In addition to treating active flare-ups, Lialda is used for the maintenance of remission. This means it is taken long-term to help keep the disease inactive and prevent symptoms from recurring. It is approved for use in both adults and pediatric patients who meet specific weight requirements.

How It Works

Lialda is a delayed-release tablet designed to pass through the stomach and release the active medicine, mesalamine, once it reaches the colon. By reducing the production of certain substances that cause inflammation in the bowel, it allows the intestinal lining to heal.

Mechanism of Action

Lialda belongs to a class of medications called aminosalicylates. It works locally in the colon to decrease inflammation. While the exact process is not completely understood, the medication is thought to block the production of certain chemicals in the body, such as prostaglandins, that cause inflammation, tissue damage, and diarrhea.

Targeted Release

Lialda is designed to deliver the active medicine, mesalamine, specifically to the large intestine. It uses a specialized delivery system that includes:

• Delayed-release coating: This protects the tablet from being broken down by stomach acid, allowing it to pass through the upper digestive tract intact.
• Multi-Matrix System (MMX): This technology allows the medication to be released slowly and consistently as it travels through the entire length of the colon.

By releasing the medication directly at the site of the disease, Lialda treats the inflamed tissue while limiting the amount of medicine absorbed into the rest of the body.

Common Side Effects

Some people may experience mild side effects while taking Lialda. These often include:

• Headache
• Stomach pain, nausea, or vomiting
• Gas or flatulence
• Diarrhea
• Dizziness
• Back pain
• Flu-like symptoms or runny nose

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious side effects:

• Mesalamine-induced acute intolerance syndrome: This condition can mimic a flare-up of ulcerative colitis. Symptoms include severe stomach cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash.
• Kidney problems: Signs may include a change in the amount of urine, increased thirst, or swelling in the hands, ankles, or feet.
• Liver issues: Symptoms include yellowing of the eyes or skin (jaundice), dark urine, loss of appetite, or pain in the upper right side of the stomach.
• Heart inflammation: Chest pain, difficulty breathing, or a fast or pounding heartbeat.
• Severe skin reactions: A red or purple skin rash that spreads and causes blistering or peeling.
• Allergic reactions: Hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Renal Impairment

Renal impairment, including cases of kidney failure and interstitial nephritis, has been reported with the use of mesalamine. It is common practice for healthcare providers to evaluate kidney function before starting treatment and periodically during therapy. Caution is advised when using this medication alongside other drugs that can affect the kidneys, such as nonsteroidal anti-inflammatory drugs (NSAIDs).

Mesalamine-Induced Acute Intolerance Syndrome

Some individuals may experience an acute intolerance syndrome that can be difficult to distinguish from an ulcerative colitis flare. Symptoms may include:

• Abdominal pain and cramping
• Bloody diarrhea
• Fever
• Headache
• Rash

If these symptoms occur, the medication is typically discontinued immediately.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the sac around the heart), have been reported. Patients with a known allergy to salicylates, such as aspirin, should not use Lialda.

Severe Skin Reactions

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with mesalamine treatment. Additionally, patients with pre-existing skin conditions like eczema or atopic dermatitis may experience increased sensitivity to sunlight while taking this medication.

Hepatic Failure

There have been reports of liver failure in patients with pre-existing liver disease who take mesalamine. Risks and benefits are usually carefully weighed for those with known hepatic impairment before starting treatment.

Nephrolithiasis

The formation of kidney stones has been reported with mesalamine use. Maintaining adequate fluid intake during treatment is generally recommended to help prevent this condition.

Drug Interactions

The use of mesalamine with certain medications may increase the risk of adverse effects. Using Lialda with azathioprine or 6-mercaptopurine may increase the risk of blood disorders, such as a decrease in white blood cells. Close monitoring of blood counts is typically required if these drugs are used together.

Pregnancy

It is not known whether Lialda will harm an unborn baby. While animal studies have not shown a high risk of birth defects, there are no adequate and well-controlled studies in pregnant women. Because the medication can cross the placenta, it should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

If you are pregnant or planning to become pregnant, discuss the risks and benefits of continuing treatment with your healthcare provider. Maintaining control of inflammatory bowel disease is important for a healthy pregnancy.

Breastfeeding

Mesalamine, the active ingredient in Lialda, is known to pass into breast milk. There have been reports of diarrhea in infants who are breastfed by people taking this medication. If you are breastfeeding, monitor your baby for changes in bowel movements or signs of irritability.

Consult your doctor to determine the best course of action while breastfeeding. They can help you weigh the benefits of breastfeeding against the potential risks of the medication to the infant.

Dosage Forms

Lialda is available in the following form:

• Delayed-release tablets: These are oral tablets that use a multi-matrix technology to delay the release of the medication until it reaches the terminal ileum and colon.

The tablets are film-coated and should be swallowed whole. They should not be crushed, chewed, or broken to ensure the medication is released properly in the digestive tract.

FDA Approval Status

Lialda (mesalamine) was approved by the U.S. Food and Drug Administration (FDA) as a delayed-release oral tablet. It belongs to a class of medications known as aminosalicylates.

Approved Indications

The FDA has approved Lialda for the following uses in patients with ulcerative colitis:

• Induction of remission: To treat active, mild to moderate ulcerative colitis in adults and pediatric patients weighing at least 24 kg.
• Maintenance of remission: To help maintain the remission of ulcerative colitis in adults.

Safety and Monitoring

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) required for Lialda. However, the FDA requires labeling that includes precautions regarding renal impairment, as mesalamine has been associated with kidney toxicity. Healthcare providers are typically advised to evaluate renal function before starting treatment and periodically during therapy.

Factors Influencing Price

The price of Lialda can vary significantly based on several variables:

• Generic Availability: Mesalamine, the active ingredient in Lialda, is available as a generic medication. Generic versions are generally less expensive than the brand-name drug.
• Insurance and Medicare: Most insurance plans and Medicare Part D provide coverage for mesalamine, though the specific copay or coinsurance amount will depend on your plan's formulary.
• Pharmacy Selection: Costs may vary between different retail pharmacies or mail-order options.

Assistance and Savings

Patients may be able to lower their out-of-pocket costs through various means:

• Patient Assistance Programs: Some manufacturers offer programs to help patients who meet specific income or insurance requirements.
• Savings Cards: Manufacturer-sponsored savings cards may be available for those with commercial insurance to reduce copayments.
• Healthcare Provider Consultation: Your doctor or pharmacist can provide information on the most cost-effective way to obtain your medication, including switching to a generic alternative if appropriate.