Apriso

Maintenance of Remission

Apriso is specifically used for the maintenance of remission in adults with ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that causes swelling, irritation, and sores in the lining of the large intestine (colon) and rectum.

When a patient is in remission, their active symptoms have subsided. Apriso is prescribed to help prolong this period and reduce the likelihood of a flare-up. It helps manage the underlying inflammation to prevent the return of symptoms such as:

• Abdominal pain or cramping
• Diarrhea
• Rectal bleeding

How It Is Used

This medication belongs to a class of drugs called aminosalicylates. It works by acting locally on the lining of the colon to reduce inflammation. While some forms of mesalamine are used to treat active flare-ups, Apriso is primarily indicated for patients who have already achieved remission to help them stay symptom-free.

It is designed to release the active medicine in the colon, providing targeted treatment where the inflammation occurs. Consistent use as directed by a healthcare provider is necessary to maintain the protective effects against future inflammation.

Mechanism of Action

Apriso contains the active ingredient mesalamine, which is an anti-inflammatory medicine. It works locally in the large intestine (colon) to reduce the symptoms of ulcerative colitis.

While the exact way mesalamine works is not fully understood, it is believed to function by blocking the production of certain chemicals in the body that cause inflammation, tissue damage, and diarrhea. By suppressing these substances, the medication helps the lining of the colon heal and stay healthy.

Delayed-Release Delivery

Apriso is designed as a delayed-release capsule. This formulation is important for how the drug works in the body:

• Targeted Release: The capsule contains granules that are coated to prevent the medicine from being released too early in the digestive process.
• Colon-Specific Action: The coating allows the medication to pass through the stomach and small intestine so that the active ingredient is released primarily once it reaches the colon.

This targeted delivery ensures that the medicine is available exactly where the inflammation occurs, rather than being absorbed entirely into the bloodstream before reaching the affected area.

Common Side Effects

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

• Headache
• Nausea or stomach pain
• Diarrhea or constipation
• Gas and bloating
• Dizziness
• Back pain
• Cold-like symptoms, such as a sore throat or runny nose

Serious Side Effects

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

• Acute Intolerance Syndrome: Severe stomach cramping, bloody diarrhea, fever, and skin rash. These symptoms may be similar to a flare-up of ulcerative colitis.
• Kidney Issues: Decreased urination, swelling in the ankles or feet, and fatigue.
• Liver Problems: Yellowing of the skin or eyes, dark urine, and upper stomach pain.
• Heart Inflammation: Chest pain, difficulty breathing, or a rapid heartbeat.
• Severe Allergic Reaction: Hives, swelling of the face or throat, and trouble breathing.

Kidney and Liver Function

Mesalamine, the active ingredient in Apriso, has been associated with kidney impairment. Healthcare providers typically monitor kidney function before and during treatment. Individuals with a history of liver disease may also face an increased risk of liver failure while taking this medication.

Acute Intolerance Syndrome

Some people experience an acute intolerance syndrome that can be difficult to distinguish from a flare-up of ulcerative colitis. Symptoms may include:

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

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

Allergies and Sensitivities

Apriso should not be used by individuals with a known hypersensitivity to salicylates, such as aspirin, or to any components of the capsule. Severe skin reactions, including Stevens-Johnson syndrome, have been reported. Additionally, the medication may increase sensitivity to sunlight, making the skin more prone to sunburn.

Phenylketonuria (PKU)

Apriso extended-release capsules contain phenylalanine. This is an important consideration for individuals with phenylketonuria, a genetic condition where the body cannot process this amino acid.

Pregnancy

The effects of mesalamine on an unborn baby are not fully understood. While animal studies have not demonstrated a risk of birth defects or other problems, there is limited information from well-controlled studies in pregnant women. Because of this, healthcare providers generally suggest using this medication during pregnancy only when the benefits outweigh the potential risks.

If you are pregnant or planning to become pregnant, talk to your doctor about the risks and benefits of continuing treatment. It is also important to consider that active inflammatory bowel disease can pose its own risks to a pregnancy.

Breastfeeding

Mesalamine can pass into breast milk. It is important to consider the following if you are nursing:

• Infant side effects: Some nursing infants have been reported to develop diarrhea when the mother is taking mesalamine.
• Monitoring: If you are breastfeeding while taking this medication, watch your baby closely for any changes in their bowel habits.

Consult with your healthcare provider to determine the safest way to feed your baby while managing your condition.

Available Forms

Apriso is available in the following form for oral administration:

• Extended-release capsules: These capsules are designed to release the active medication gradually as they pass through the digestive tract.

Generic versions of these extended-release capsules are also available.

FDA Approval and Indications

Apriso was approved by the U.S. Food and Drug Administration (FDA) specifically for the maintenance of remission of ulcerative colitis in adults. Remission refers to the period when the symptoms of the disease are under control or have disappeared. This medication is not currently approved for use in children.

Generic Availability

The FDA has approved generic versions of Apriso. Generic mesalamine extended-release capsules are available and are required to meet the same quality and safety standards as the brand-name product.

Regulatory Requirements

Apriso is not a controlled substance and does not currently require a Risk Evaluation and Mitigation Strategy (REMS) program. There are no boxed warnings associated with this medication. However, regulatory authorities require that the drug be dispensed with a medication guide to inform patients about potential risks, such as kidney impairment or serious skin reactions.

Generic Availability

A generic version of Apriso, known as mesalamine extended-release capsules, is available. Generic medications contain the same active ingredients as the brand-name version but are typically available at a lower cost.

Insurance and Medicare Coverage

Most private insurance plans and Medicare Part D plans provide coverage for mesalamine. However, the specific out-of-pocket cost depends on the plan's formulary. Brand-name Apriso may be placed in a higher cost-sharing tier than its generic equivalent, leading to higher copays.

Factors Influencing Price

The final price paid at the pharmacy can be affected by various factors:

• Pharmacy Choice: Prices may vary between retail pharmacies, and some mail-order services may offer different pricing structures.
• Prescription Quantity: Filling a 90-day supply instead of a 30-day supply may sometimes reduce the overall cost per dose, depending on insurance policies.
• Financial Assistance: Some patients may be eligible for manufacturer savings cards or patient assistance programs that help reduce the cost of the brand-name medication.