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SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution.
The active ingredients contained in SUFLAVE are provided in Table 3.
Table 3: Active Ingredients in SUFLAVE
| Chemical Name | Chemical Formula | Average Molecular Weight (g/mol) | Chemical Structure |
| Polyethylene Glycol 3350, USP |  |
3350 |  |
| Sodium Sulfate, USP | N2SO4 | 142.04 |  |
| Magnesium Sulfate, USP | MgSO4 | 120.37 |  |
| Potassium Chloride, USP | KCl | 74.55 |  |
| Sodium Chloride, USP | NaCl | 58.44 |  |
Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame.
Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose.
Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose.
SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE:
The Day Prior to Colonoscopy:
If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
Continue to consume only clear liquids until after the colonoscopy.
After reconstitution, keep solution refrigerated 2°C to 8°C (36°F to 46°F). Do not freeze. Use within 24 hours, discard unused solution.
SUFLAVE is supplied as a white powder for reconstitution and is available in a carton that contains two bottles and two flavor enhancing packets.
When diluted as directed, the solution is slightly hazy to hazy.
SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is supplied as a white powder for reconstitution and is lemon-lime flavored.
Each carton of SUFLAVE (NDC 52268-550-01) contains:
Two bottles, each bottle (NDC 52268-551-01), closed with child resistant closure, contains a white powder of 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride for reconstitution. The bottle contains lemon-lime flavor.
Two flavor enhancing packets (NDC 52268-552-01).
Store SUFLAVE at room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.
Manufactured by: Braintree Laboratories, Inc. 270 Centre Street Holbrook, MA 02343. Revised: Jun 2023
The following serious or otherwise important adverse reactions are described elsewhere in the labeling:
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].
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 Reactionsa by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 1b
| 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 painc | 3 | 4 |
| Headache | 3 | 2 |
| 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. |
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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 Reactionsa by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 2b
| SUFLAVE (%) N=227 |
Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (%) N=226 |
|
| Nausea | 7 | 6 |
| Vomiting | 4 | 7 |
| Headache | 2 | 2 |
| Abdominal painc | 3 | 1 |
| Abdominal distension | 1 | 1 |
| 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. |
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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.
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.
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].
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].
Nervous system: tremor, seizure [see WARNINGS AND PRECAUTIONS]
Use caution when prescribing SUFLAVE to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT interval in the setting of fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS].
SUFLAVE can reduce the absorption of other co-administered drugs [see DOSAGE AND ADMINISTRATION]:
Concurrent use of stimulant laxatives and SUFLAVE may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUFLAVE [see WARNINGS AND PRECAUTIONS].
Included as part of the PRECAUTIONS section.
Advise all patients to hydrate adequately before, during, and after the use of SUFLAVE. If a patient develops significant vomiting or signs of dehydration after taking SUFLAVE, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN).
Bowel preparation products can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see ADVERSE REACTIONS]. Correct fluid and electrolyte abnormalities before treatment with SUFLAVE. Use SUFLAVE with caution in patients with conditions, or who are using medications [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)], that increase the risk for fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and renal impairment [see DRUG INTERACTIONS].
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing SUFLAVE for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT interval, 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.
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 SUFLAVE 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].
Use SUFLAVE 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]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUFLAVE and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use In Specific Populations].
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 SUFLAVE may increase these risks [see DRUG INTERACTIONS]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease.
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUFLAVE [see CONTRAINDICATIONS].
Use with caution in patients with severe active ulcerative colitis.
Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of SUFLAVE. Observe these patients during administration of SUFLAVE.
Do not combine SUFLAVE with starch-based thickeners [see DOSAGE AND ADMINISTRATION]. Polyethylene glycol (PEG), a component of SUFLAVE, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.
SUFLAVE contains polyethylene glycol (PEG) and other ingredients that may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see ADVERSE REACTIONS]. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Instruct patients:
There are no available data on the use of SUFLAVE during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (SUFLAVE).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There are no available data on the presence of SUFLAVE in human or animal milk, the effects on the breastfed child, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUFLAVE and any potential adverse effects on the breastfed child from SUFLAVE or from the underlying maternal condition.
The safety and effectiveness of SUFLAVE in pediatric patients have not been established.
Of the 460 patients who received SUFLAVE in clinical trials, 125 (27%) were 65 years of age or older. No differences in effectiveness of SUFLAVE were observed between geriatric patients and younger adult patients. Among geriatric patients, decreases in blood pressure on the day of colonoscopy were reported more frequently with SUFLAVE than with the active comparator in Study 1 (6% in SUFLAVE-treated patients and 1% in patients treated with active comparator) in Study 2 (3% in SUFLAVE-treated patients and 0% treated with active comparator) [see Clinical Studies].
Geriatric patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS]. Advise geriatric patients to hydrate adequately before, during, and after the use of SUFLAVE.
Use SUFLAVE with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of SUFLAVE, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see WARNINGS AND PRECAUTIONS].
Overdosage of more than the recommended dose of SUFLAVE may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see WARNINGS AND PRECAUTIONS]. Monitor for fluid and electrolyte disturbances and treat symptomatically.
SUFLAVE is contraindicated in the following conditions:
The primary mode of action is the osmotic effects of polyethylene glycol 3350, sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.
After administration of the first dose of SUFLAVE in 18 healthy subjects, the mean ± SD maximum plasma concentration (Cmax) for polyethylene glycol 3350 of 3.4 ± 1.4 mcg/mL was reached at 4 hours, and the mean ± SD serum Cmax for sulfate of 27.0 ± 11.4 mcg/mL was reached at 6 hours. Following a second dose of SUFLAVE (approximately 12 hours later), the mean ± SD plasma Cmax for polyethylene glycol 3350 of 2.9 ± 0.97 mcg/mL was reached at 4 hours, and the mean ± SD serum Cmax for sulfate of 29.2 ± 11.0 mcg/mL was reached at 3 hours. Sulfate concentrations were below the limit of quantitation (19.2 mcg/mL) for all subjects by follow-up Day 3. Polyethylene glycol 3350 concentrations were below the limit of quantitation (LOQ 0.01 mcg/mL) for 16 of 18 subjects by follow-up Day 7.
The colon cleansing efficacy of SUFLAVE was evaluated in two randomized, single-blind, active-controlled, multicenter trials (Study 1 and Study 2). These trials included adult patients undergoing colonoscopy for colorectal cancer screening and surveillance, or diagnostic colonoscopy, including patients with abdominal pain, diarrhea, constipation and non-severe inflammatory bowel disease.
In Study 1 (NCT04446299), 471 adult patients were included in the efficacy analysis. Patients ranged in age from 20 to 84 years (median age 58 years) and 54% were female. The racial distribution was 70% White, 27% African-American, 2% Asian, and 1% American Indian or Alaska Native. The population was 8% Hispanic or Latino. Patients were randomized to one of the following two colon preparation regimens: SUFLAVE or polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution. Both preparations were administered according to a split-dose regimen [see DOSAGE AND ADMINISTRATION]. Patients receiving SUFLAVE were limited to a low residue breakfast followed by clear liquids on the day prior to the colonoscopy; patients receiving the comparator bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids and/or yogurt for dinner on the day prior to the colonoscopy.
In Study 2 (NCT04446312), 450 adult patients were included in the efficacy analysis. Patients ranged in age from 18 to 80 years (median age 57 years) and 58% were female. The racial distribution was 85% White, 10% African-American, 3% Asian, and < 1% American Indian or Alaska Native. The population was 21% Hispanic or Latino. Patients were randomized to one of the following two colon preparation regimens: SUFLAVE or sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Both preparations were administered according to a split-dose regimen [see DOSAGE AND ADMINISTRATION]. Patients receiving SUFLAVE were limited to a low residue breakfast followed by clear liquids on the day prior to the colonoscopy; patients receiving the comparator bowel prep were allowed a light breakfast followed by clear liquids on the day prior to the colonoscopy.
The primary efficacy endpoint in each trial was the proportion of patients with successful colon cleansing, as assessed by the blinded colonoscopist utilizing the four-point scale described in Table 4. Success was defined as an overall cleansing assessment of 3 (Good) or 4 (Excellent).
Table 4: Description of Colonoscopy Scoring
| Score | Grade | Description |
| 1 | Poor | Large amount of fecal residue, additional bowel preparation required. |
| 2 | Fair | Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa. |
| 3 | Good | Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa. |
| 4 | Excellent | No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa. |
Results for the primary endpoint in Studies 1 and 2 are shown in Table 5. In both trials, SUFLAVE was non-inferior to the active comparator.
Table 5: Proportion of Adult Patients with Overall Cleansing Successa in Two Controlled Trials with a Split-Dose Regimen
| SUFLAVE % (n/N) | Active Comparator % (n/N) | SUFLAVE-Active Comparator | ||
| Differenceb (%) | 95% Confidence Intervalb | |||
| Study 1 | 93% (215/232) | 89%c (212/239) | 3.4% | (-1.7%, 8.5%)e |
| Study 2 | 94% (212/226) | 94%d (211/224) | 0.2% | (-4.0%, 4.3%)e |
| a success was defined as an overall cleaning assessment of 3 (Good) or 4 (Excellent) by the blinded endoscopist, with scores assigned on withdrawal of colonoscope. b common risk differences and confidence intervals were based on the Mantel-Haenszel method adjusting for study site c active comparator in Study 1 was polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution d active comparator in Study 2 was sodium sulfate, potassium sulfate, and magnesium sulfate oral solution e non-inferiority was demonstrated |
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SUFLAVE®
(Soo-FLAVE)
(polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution)
Read and understand this Medication Guide and the Instructions for Use at least 2 days before your colonoscopy and again before you start taking SUFLAVE.
What is the most important information I should know about SUFLAVE?
SUFLAVE and other bowel preparations can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.
These changes can cause:
Your chance of having fluid loss and changes in body salts with SUFLAVE is higher if you:
Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUFLAVE:
See “What are the possible side effects of SUFLAVE?” for more information about side effects.
What is SUFLAVE?
SUFLAVE is a prescription medicine used by adults to clean the colon before a colonoscopy. SUFLAVE cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.
It is not known if SUFLAVE is safe and effective in children.
Do not take SUFLAVE if your healthcare provider has told you that you have:
Before taking SUFLAVE, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
SUFLAVE may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUFLAVE.
Especially tell your healthcare provider if you take:
The following medicines should be taken at least 2 hours before starting each dose of SUFLAVE and not less than 6 hours after taking each dose of SUFLAVE:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take SUFLAVE?
See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take SUFLAVE the right way.
Contact your healthcare provider right away if after taking SUFLAVE you have severe vomiting, signs of too much fluid loss (dehydration), abnormal heartbeats or seizures.
What are the possible side effects of SUFLAVE?
SUFLAVE can cause serious side effects, including:
The most common side effects of SUFLAVE include:
These are not all the possible side effects of SUFLAVE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SUFLAVE?
Keep SUFLAVE and all medicines out of the reach of children.
General information about the safe and effective use of SUFLAVE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUFLAVE for a condition for which it was not prescribed. Do not give SUFLAVE to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in SUFLAVE?
Active ingredients: polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride.
Inactive ingredients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
