Apriso

Apriso is part of the drug class:

• Aminosalicylic acid and similar agents

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

This is not a complete list of Apriso drug interactions. Ask your doctor or pharmacist for more information.

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 Apriso, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Apriso is excreted in human breast milk. The effect of Apriso on the nursing infant is not known.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take mesalamine with a full glass of water.

Lialda should be taken with a meal.

Other brands of mesalamine can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label.

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

Call your doctor if you find undissolved tablets in your stool.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking mesalamine.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Delzicol® for the treatment of ulcerative colitis in children 5 years and older. Safety and efficacy have not been established in children younger than 5 years. The safety and efficacy of Delzicol® have not been established for the prevention of ulcerative colitis in children.

Appropriate studies have not been performed on the relationship of age to the effects of Apriso™, Asacol® HD, Lialda®, or Pentasa® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mercaptopurine
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Varicella Virus Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tamarind
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to sulfasalazine (Azulfidine®)—May cause side effects to become worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use with caution. May make this condition worse.

• Phenylketonuria (PKU)—The Apriso™ capsules contain aspartame, which may require caution in patients with PKU.

• It is used to treat ulcerative colitis.
• It is used to help keep ulcerative colitis flares from coming back.
• It may be given to you for other reasons. Talk with the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Apriso (mesalamine long-acting capsules (apriso)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Apriso. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Apriso.

Review Date: October 4, 2017

Clinical Studies Experience

The data described below reflect exposure to Apriso in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. Apriso was studied in two placebo-controlled trials (n = 367 treated with Apriso) and in one open-label, long-term study (n = 190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of Apriso 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the open-label study.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two placebo-controlled trials, 59% of Apriso-treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with Apriso were mild or moderate in severity. Severe adverse reactions occurred in 6% of Apriso-treated patients and 5% of placebo-treated patients. Discontinuations due to adverse reactions occurred in 11% of Apriso-treated patients and 17% of placebo-treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (Apriso 6%, placebo 14%). The most common reactions reported with Apriso (≥3%) are shown in Table 1 below.

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with Apriso for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: abdominal pain lower, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Adverse Reaction Information from Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to Apriso and post approval use of other mesalamine-containing products such as Apriso.  Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular:  pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia

Apriso is an aminosalicylate, and symptoms of salicylate toxicity include hematemesis, tachypnea, hyperpnea, tinnitus, deafness, lethargy, seizures, confusion, or dyspnea. Severe intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement.  There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. This includes prevention of further gastrointestinal tract absorption by emesis and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.  Apriso is a pH-dependent delayed-release product and this factor should be considered when treating a suspected overdose.

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine).

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Clinical Studies Experience

The data described below reflect exposure to APRISO in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO was studied in two placebocontrolled trials (n = 367 treated with APRISO) and in one open-label, long-term study (n = 190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of APRISO 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the openlabel study.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two placebo-controlled trials, 59% of APRISO-treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with APRISO were mild or moderate in severity. Severe adverse reactions occurred in 6% of APRISO-treated patients and 5% of placebotreated patients. Discontinuations due to adverse reactions occurred in 11% of APRISO-treated patients and 17% of placebo-treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (APRISO 6%, placebo 14%). The most common reactions reported with APRISO (≥ 3%) are shown in Table 1 below.

Table 1: Treatment-Emergent Adverse Reactions during Clinical Trials Occurring in at Least 3% of APRISO-Treated Patients and at a Greater Rate than with Placebo

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with APRISO for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: abdominal pain lower, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Adverse Reaction Information From Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to APRISO and post approval use of other mesalamine-containing products such as APRISO. Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular: pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Nervous System: intracranial hypertension

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barr� syndrome, transverse myelitis

Renal and Urinary: nephrogenic diabetes insipidus

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia

Read the entire FDA prescribing information for Apriso (Mesalamine Extended-Release Capsules)

Take Apriso exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Apriso with a full glass of water.

Apriso can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label.

Do not crush, break, or chew an Apriso extended-release capsule. Swallow the capsule whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking open the capsule may cause the medicine to be released too early in the digestive tract.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

Apriso can cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking mesalamine.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Common side effects of Apriso include: headache. See below for a comprehensive list of adverse effects.