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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 ) Colonic mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 4 , 5.6 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.7 ) Risk of Gastrointestinal Complications with Ingestion of Desiccant : Postmarketing reports of ingestion of the desiccant along with SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking. ( 2.2 , 5.8 ) 5.1 Serious Fluid and Electrolyte Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions ( 7.1 )] . 5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 5.3 Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )] . 5.4 Use in Patients with Risk of Renal Injury Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations ( 8.6 )] . 5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks [see Drug Interactions ( 7.3 )] . Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). 5.6 Use in Patients with Significant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB [see Contraindications ( 4 )] . Use with caution in patients with severe active ulcerative colitis. 5.7 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus and urticaria have been reported with SUTAB [see Adverse Reactions ( 6.2 )] . Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur. 5.8 Risk of Gastrointestinal Complications with Ingestion of Desiccant Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )]. Postmarketing reports of patients ingesting the desiccant along with the SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking.
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. The safety of SUTAB was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 941 adult patients undergoing colonoscopy. The active comparators were polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution in Study 1 and sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution in Study 2 [see Clinical Studies ( 14 )] . Adverse Gastrointestinal Reactions Reported by Symptom Questionnaire In Studies 1 and 2, patients were queried for selected gastrointestinal adverse reactions of stomach cramping (upper abdominal pain), stomach bloating (abdominal distention), nausea and vomiting using a standard questionnaire following completion of study drug and prior to colonoscopy on the day of colonoscopy. Patients reporting selected gastrointestinal symptom(s) rated the intensity as mild, moderate or severe. A total of 52% (287/552) of patients in Study 1 and 52% (202/389) in Study 2 reported at least one selected gastrointestinal adverse reaction when queried using the standard questionnaire. Tables 1 and 2 show results for each gastrointestinal adverse reaction reported by patients using the standard questionnaire, including severity. Table 1: Gastrointestinal Symptoms by Severity a From Symptom Questionnaire in Adult Patients Following Colon Cleansing and Prior to Colonoscopy – Study 1 b Symptom SUTAB Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate Total Number of Patients per Treatment Arm (N) 281 271 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 163 124 % Nausea c 48 26 Mild 71 77 Moderate 27 23 Severe 2 0 % Abdominal Distension c,d 29 22 Mild 68 71 Moderate 30 29 Severe 1 0 % Vomiting c 23 5 Mild 48 46 Moderate 52 54 Severe 0 0 % Upper Abdominal Pain c 16 18 Mild 65 71 Moderate 35 29 Severe 0 0 a Mild : barely noticeable, does not influence functioning causing no limitations of usual activities; Moderate: makes participant uncomfortable, influences functioning causing some limitations of usual activities; Severe: severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities b Study 1 was not designed to support comparative claims for SUTAB for the adverse reactions reported in this table. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. d Total not equal to 100% due to rounding. Table 2: Gastrointestinal Symptoms by Severity a From Symptom Questionnaire in Adult Patients Following Colon Cleansing and Prior to Colonoscopy – Study 2 b Symptom SUTAB Sodium picosulfate, magnesium oxide, and anhydrous citric acid Total Number of Patients per Treatment Arm (N) 190 199 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 135 67 % Nausea c 52 18 Mild 74 94 Moderate 20 6 Severe 6 0 % Abdominal Distension c 34 15 Mild 73 69 Moderate 27 31 Severe 0 0 % Vomiting c 16 2 Mild 53 33 Moderate 47 67 Severe 0 0 % Upper Abdominal Pain c 23 13 Mild 82 100 Moderate 16 0 Severe 2 0 a Mild: barely noticeable, does not influence functioning causing no limitations of usual activities; Moderate: makes participant uncomfortable, influences functioning causing some limitations of usual activities; Severe: severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities b Study 2 was not designed to support comparative claims for SUTAB for the adverse reactions reported in this table. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. Additional Adverse Reactions Reported in Studies 1 and 2 In addition to the gastrointestinal symptoms reported on the standard questionnaire (Tables 1 and 2), other adverse reactions reported in at least 2% of patients in either treatment arm in Studies 1 and 2 were: dizziness in Study 1 (0% SUTAB and 2% comparator); and hypermagnesemia (2% SUTAB and 2% comparator) and increased liver function test (including ALT, AST and bilirubin) (3% SUTAB and 1% comparator) in Study 2. Laboratory Changes Electrolyte Abnormalities Shifts in serum electrolytes from normal at baseline to above the upper end of normal following study drug on the day of colonoscopy in at least 2% of patients in either treatment arm and at least 2% greater in patients treated with SUTAB than treated with comparator in either Study 1 or Study 2 were: magnesium (27% SUTAB and 5% comparator in Study 1), and serum osmolality (44% SUTAB and 28% comparator in Study 2). These changes were transient and resolved without intervention. Renal Function Parameters Decreases in creatinine clearance and increases in blood urea nitrogen (BUN) were reported in less than 1% of patients in both SUTAB and comparator arms in both trials. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of SUTAB. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal : gastric ulceration, gastritis Hypersensitivity : anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warnings and Precautions ( 5.7 )]