Apriso

The active ingredient in Apriso is mesalamine, which is also known as 5-aminosalicylic acid (5-ASA). Its mechanism of action is from its anti-inflammatory properties, which reduce the production of prostaglandins, resulting in a decrease in the inflammation that’s seen in the colon. It can decrease the symptoms of ulcerative colitis, including rectal bleeding, and help prevent flare-ups.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Apriso. However, the following is a synopsis of the general guidelines for the use of Apriso:

• The recommended dose is 1.5 g once daily in the morning.
• Ensure a sun safety routine is practiced, which includes a broad-spectrum sunscreen with at least SPF 30 and wearing protective clothing.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose.

Some mild and common side effects of Apriso seen in clinical trials include:

• Headache
• Stomach pain
• Dizziness
• Diarrhea
• Nausea and vomiting
• Back pain
• Constipation
• Cold symptoms
• Rash
• Increased sun sensitivity

Some individuals may experience serious side effects while using Apriso. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reaction: trouble breathing, hives or skin rash like Stevens-Johnson Syndrome, enlarged lymph nodes, or swelling of the face, eyes, or tongue
• Kidney damage: decreased urination, fatigue, and swelling of the legs, feet, arms, or hands
• Kidney stones: Lower back pain, bloody urine, and stomach pain
• Mesalamine-Induced Acute Intolerance Syndrome: abdominal pain, cramping, and bloody diarrhea
• Liver problems: yellowing of the eyes and skin, loss of appetite, or dark urine
• Low white blood cell count: sore throat, fever, and chills

These are not all of the possible side effects of Apriso. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Apriso, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Anemia
• Kidney problems
• History of pericarditis or myocarditis
• Liver disease
• Hypersensitivity to sulfasalazine
• Obstruction in the upper GI tract
• Skin conditions, including eczema or psoriasis
• Blood cell count disorder
• Phenylketonuria (PKU)

Do not use Apriso if you have:

• Known allergy to salicylates or aspirin
• Known allergy to mesalamine or any of its ingredients, including phenylalanine

This medication will improve symptoms within several weeks, so it’s important to ensure consistency and medication adherence.

When Apriso is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Azathioprine
• 6-mercaptopurine
• Antacids
• NSAIDs (nonsteroidal anti-inflammatory drugs)

The dosage forms available include delayed-release Apriso capsules. The strength available includes a 375 mg extended-release capsule.

This medication should be stored at room temperature and away from the reach of children.

The pharmaceutical company that manufactures Apriso is Salix Pharmaceuticals Inc.

There are lower-cost alternatives for the brand names Apriso, Lialda, or Pentasa.

Before stopping this medication, consult your healthcare provider, as tapering is required for this medication.

It is unknown if Apriso can cause harm to your unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Apriso can pass into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.