SUFLAVE
Generic: POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION
Basic Information
Manufacturer
Braintree Laboratories, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
546cfc44-791c-4524-99a9-6a0af96c4ec8
Indications & Usage
1 INDICATIONS AND USAGE SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
SUFLAVE is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
SUFLAVE is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
Adverse Reactions
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 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc.
at 1-800-874-6756 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 trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUFLAVE was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 929 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 sulfate, potassium sulfate, and magnesium sulfate oral solution in Study 2 [see Clinical Studies ( 14 )] .
Table 1 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 1.
Table 1: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 1 b a Reported in at least 2% of patients in either treatment group.
b Study 1 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table.
c Abdominal pain is composed of several similar terms.
SUFLAVE (%) N=233 Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution (%) N=243 Nausea 13 9 Abdominal distension 6 3 Vomiting 6 3 Abdominal pain c 3 4 Headache 3 2 Table 2 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 2.
Table 2: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 2 b a Reported in at least 2% of patients in any treatment group.
b Study 2 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table.
c Abdominal pain is composed of several similar items.
SUFLAVE (%) N=227 Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (%) N=226 Nausea 7 6 Vomiting 4 7 Headache 2 2 Abdominal pain c 3 1 Abdominal distension 1 1 Laboratory Changes Electrolyte Abnormalities In patients with normal baseline values, the most common electrolyte abnormality following study drug, on the day of colonoscopy, was increased magnesium (Study 1: 11% in SUFLAVE-treated patients and 2% in patients treated with active comparator; Study 2: 12% in SUFLAVE-treated patients and 11% in patients treated with active comparator).
These changes were transient and resolved without intervention.
Renal Function Parameters In patients with normal baseline values, at 48 to 72 hours after bowel preparation, an increase in serum creatinine of > 0.3 mg/dL and/or a decrease in eGFR of > 25% were reported in 2% of SUFLAVE-treated patients and 0 patients treated with active comparator in Study 1 and 1% of SUFLAVE-treated patients and 3% of patients treated with active comparator in Study 2.
These changes were transient and resolved.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of other polyethylene glycol-based products.
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.
Cardiovascular : arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema [see Warnings and Precautions ( 5.2 )] .
Gastrointestinal : upper gastrointestinal bleeding from a Mallory-Weiss tear; esophageal perforation, usually with gastroesophageal reflux disease Hypersensitivity reactions : rash, urticaria, pruritus, dermatitis, dyspnea, chest tightness and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Warnings and Precautions ( 5.8 )] .
Nervous system : tremor, seizure [see Warnings and Precautions ( 5.3 )]
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc.
at 1-800-874-6756 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 trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUFLAVE was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 929 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 sulfate, potassium sulfate, and magnesium sulfate oral solution in Study 2 [see Clinical Studies ( 14 )] .
Table 1 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 1.
Table 1: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 1 b a Reported in at least 2% of patients in either treatment group.
b Study 1 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table.
c Abdominal pain is composed of several similar terms.
SUFLAVE (%) N=233 Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution (%) N=243 Nausea 13 9 Abdominal distension 6 3 Vomiting 6 3 Abdominal pain c 3 4 Headache 3 2 Table 2 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 2.
Table 2: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 2 b a Reported in at least 2% of patients in any treatment group.
b Study 2 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table.
c Abdominal pain is composed of several similar items.
SUFLAVE (%) N=227 Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (%) N=226 Nausea 7 6 Vomiting 4 7 Headache 2 2 Abdominal pain c 3 1 Abdominal distension 1 1 Laboratory Changes Electrolyte Abnormalities In patients with normal baseline values, the most common electrolyte abnormality following study drug, on the day of colonoscopy, was increased magnesium (Study 1: 11% in SUFLAVE-treated patients and 2% in patients treated with active comparator; Study 2: 12% in SUFLAVE-treated patients and 11% in patients treated with active comparator).
These changes were transient and resolved without intervention.
Renal Function Parameters In patients with normal baseline values, at 48 to 72 hours after bowel preparation, an increase in serum creatinine of > 0.3 mg/dL and/or a decrease in eGFR of > 25% were reported in 2% of SUFLAVE-treated patients and 0 patients treated with active comparator in Study 1 and 1% of SUFLAVE-treated patients and 3% of patients treated with active comparator in Study 2.
These changes were transient and resolved.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of other polyethylene glycol-based products.
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.
Cardiovascular : arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema [see Warnings and Precautions ( 5.2 )] .
Gastrointestinal : upper gastrointestinal bleeding from a Mallory-Weiss tear; esophageal perforation, usually with gastroesophageal reflux disease Hypersensitivity reactions : rash, urticaria, pruritus, dermatitis, dyspnea, chest tightness and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Warnings and Precautions ( 5.8 )] .
Nervous system : tremor, seizure [see Warnings and Precautions ( 5.3 )]