SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) kit
Braintree Laboratories, Inc.
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.
2 DOSAGE AND ADMINISTRATION
Preparation and Administration ( 2.1)
- Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy.
- One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
- Each bottle must be reconstituted with water before ingestion.
- An additional 16 ounces of water must be consumed after each dose.
- Stop consumption of all fluids at least 2 hours before the colonoscopy.
Recommended Dosage and Administration ( 2.2)
- The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE
:
o Day 1, Dose 1: Evening before Colonoscopy: 1 bottle with flavor enhancing packet
o Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1):1 bottle with flavor enhancing packet - For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1, 2.2)
2.1 Important Preparation and Administration Instructions
- Correct fluid and electrolyte abnormalities before treatment with SUFLAVE [see Warnings and Precautions ( 5.1)]
- Two doses of SUFLAVE are required for a complete preparation for colonoscopy. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
- Reconstitue each bottle with water before ingestion. Do not reconstitute SUFLAVE with liquids other than water and/or add starch-based thickeners to the mixing bottle [see Warnings and Precautions ( 5.7)] .
- Must consume an additional 16 ounces of water after each dose of SUFLAVE.
- Consume a low residue breakfast on the day before colonoscopy. After breakfast, only consume clear liquids up to 2 hours prior to colonoscopy.
- Do not eat solid food or drink milk or eat or drink anything colored red or purple.
- Do not drink alcohol.
- Do not take other laxatives while taking SUFLAVE. [see Drug Interactions ( 7.3)].
- Do not take oral medications within 1 hour of starting each dose of SUFLAVE. [see Drug Interactions ( 7.2)].
- If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of SUFLAVE [see Drug Interactions ( 7.2)] .
- Stop consumption of all fluids at least 2 hours prior to the colonoscopy.
- If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
2.2 Split-Dose (2-Day) Recommended Doasge
The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE:
- Day 1, Dose 1: Evening before Colonoscopy: 1 bottle with flavor enhancing packet
- Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): 1 bottle with flavor enhancing packet
2.3 Preparation and Administration Instructions
The Day Prior to Colonoscopy:
- A low residue breakfast may be consumed. Examples of low residue foods are white bread, biscuits, muffins (no wheat), cornflakes, eggs, cream of wheat, grits, yogurt, cottage cheese, coffee, tea, juice without pulp, fruit (no skin or seeds).
- After breakfast, only consume clear liquids until after the colonoscopy. Examples of clear liquids are water, fruit juice (without pulp), lemonade, plain coffee, tea (no cream or non-dairy creamer), chicken broth, gelatin dessert (no fruit or topping).
- No red or purple liquids, no milk or alcoholic beverages.
Day 1, Dose 1 - Early in the Evening Prior to Colonoscopy:
- Open 1 flavor enhancing packet and pour the contents into 1 bottle.
- Fill the provided bottle with lukewarm water up to the fill line. After capping the bottle, gently shake the bottle until all powder has dissolved. For best taste, refrigerate the solution for an hour before drinking. Do not freeze. Use within 24 hours.
- Drink 8 ounces of solution every 15 minutes until the bottle is empty.
- Drink an additional 16 ounces of water during the evening.
If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
Day 2, Dose 2 - The Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1):
Continue to consume only clear liquids until after the colonoscopy.
- Repeat Step 1 to Step 3 from Day 1, Dose 1.
- Drink an additional 16 ounces of water during the morning.
- Stop drinking liquids at least 2 hours 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.
Storage of Reconstituted Solution
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.
3 DOSAGE FORMS AND STRENGTHS
SUFLAVE is supplied as a white powder for reconstitution and is available in a carton that contains two bottles and two flavor enhancing packets.
- 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. The bottle contains lemon-lime flavoring.
When diluted as directed, the solution is slightly hazy to hazy.
For Oral Solution: Two bottles and two flavor enhancing packets.
- 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. The bottle also contains lemon-lime flavoring. ( 3)
4 CONTRAINDICATIONS
SUFLAVE is contraindicated in the following conditions:
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)
- Colonic mucosal ulcerations: Consider potential for ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5)
- 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)
- Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ( 4, 5.6)
- Patients at risk for aspiration: Observe during administration ( 5.7)
- Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur ( 5.8)
5.1 Serious Fluid and Electrolyte Abnormalities
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 ( 6.2)] . 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 ( 7.1)] .
5.2 Cardiac Arrythmias
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.
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 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 ( 7.1)] .
5.4 Use in Patients with Risk of Renal Injury
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 ( 7.1)] . 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 postcolonoscopy 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 SUFLAVE 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.
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 SUFLAVE [see Contraindications ( 4)] .
Use with caution in patients with severe active ulcerative colitis.
5.7 Aspiration
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 ( 2.1)] . 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.
5.8 Hypersensitivity Reactions
SUFLAVE contains polyethylene glycol (PEG) and other ingredients that may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [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.
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.
aReported in at least 2% of patients in either treatment group. |
||||
bStudy 1 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. |
||||
cAbdominal pain is composed of several similar terms. |
||||
SUFLAVE
|
Polyethylene glycol 3350, sodium sulfate,
solution (%)
|
|||
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.
aReported in at least 2% of patients in any treatment group. |
||||
bStudy 2 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. |
||||
cAbdominal pain is composed of several similar items. |
||||
SUFLAVE
|
Sodium sulfate, potassium sulfate, and
|
|||
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)]
7 DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1)
7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities
Use caution when prescribing SUFLAVE to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4)] .
7.2 Potential for Reduced Drug Absorption
SUFLAVE can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1)] :
- Administer oral medications at least one hour before starting each dose of SUFLAVE.
- Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUFLAVE to avoid chelation with magnesium.
7.3 Stimulant Laxatives
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 ( 5.5)] .
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
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.
8.2 Lactation
Risk Summary
There are no available data on the presence of SUFLAVE in human or animal milk, the effects of 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.
8.4 Pediatric Use
The safety and effectiveness of SUFLAVE in pediatric patients have not been established.
8.5 Geriatric Use
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 ( 14)] .
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 ( 5.1)] . Advise geriatric patients to hydrate adequately before, during, and after the use of SUFLAVE.
8.6 Renal Impairment
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 use of SUFLAVE and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warning and Precautions ( 5.4)] .
10 OVERDOSAGE
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 ( 5.1, 5.2, 5.3)] . Monitor for fluid and electrolyte disturbances and treat symptomatically.
11 DESCRIPTION
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.
Chemical Name | Chemical Formula | Average Molecular
Weight (g/mol) |
Chemical Structure |
Polyethlyene Glycol
3350, USP |
PEG3350
![]() |
3350 |
PEG3350
![]() |
Sodium Sulfate, USP | Na 2SO 4 | 142.04 |
Sodium Sulfate
![]() |
Magnesium Sulfate, USP | MgSO 4 | 120.37 |
Magnesium Sulfate
![]() |
Potassium Chloride, USP | KCl | 74.55 |
Potassium Chloride
![]() |
Sodium Chloride, USP | NaCl | 58.44 | Na +Cl - |
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.
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/PEG3350.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/PEG3350-1.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/Na2SO4.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/MgSO4.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/KCl.jpg)
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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.
12.3 Pharmacokinetics
After administration of the first dose of SUFLAVE in 18 healthy subjects, the mean ± SD maximum plasma concentration (C max) for polyethylene glycol 3350 of 3.4 ± 1.4 mcg/mL was reached at 4 hours, and the mean ± SD serum C maxfor 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 C maxfor polyethylene glycol 3350 of 2.9 ± 0.97 mcg/mL was reached at 4 hours, and the mean ± SD serum C maxfor 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.
14 CLINICAL STUDIES
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 ( 2.2)] . 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 ( 2.2)] . 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).
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.
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 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 |
||||
enon-inferiority was demonstrated |
||||
SUFLAVE % (n/N) |
Active
% (n/N) |
SUFLAVE-Active Comparator |
||
Difference b(%) |
99% Confidence Interval b |
|||
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 |
16 HOW SUPPLIED/STORAGE AND HANDLING
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).
Storage
Store SUFLAVE at room temperature between 20º to 25°C (68º to 77°F), excursions permitted from 15º to 30°C (59º to 86°F). See USP controlled room temperature.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Instruct patients:
- Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy.
- Must reconstitute each bottle with water before ingestion.
- Must consume an additional 16 ounces of water after each dose of SUFLAVE.
- To hydrate adequately with clear liquids before, during, and after the use of SUFLAVE to prevent dehydration [see Warnings and Precautions ( 5.1)] . Examples of clear liquids can be found in the Instructions for Use.
- If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
- Do not take other laxatives while taking SUFLAVE.
- Do not drink milk or eat or drink anything colored red or purple.
- Do not drink alcohol.
- Do not take oral medications within one hour of starting each dose of SUFLAVE [see Drug Interactions ( 7.2)] .
- If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of SUFLAVE [see Drug Interactions ( 7.2)] .
- Complete all SUFLAVE and required water at least two hours prior to colonoscopy.
- Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUFLAVE or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1, 5.2, 5.3)] .
- Seek immediate medical care if signs and symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.8)] .
Manufactured by:
Braintree Laboratories, Inc.
270 Centre Street
Holbrook, MA 02343
Please see www.sebelapharma.com for patent information.
© Braintree Laboratories, Inc.
MEDICATION GUIDE SUFLAVE ®(Soo-FLAVE) (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate,
|
Read and understand this Medication Guide and the Instructions for Use at least 2 days beforeyour 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:
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.
|
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.
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:
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?
|
What are the possible side effects of SUFLAVE?
The most common side effects of SUFLAVE include:
vomiting
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.
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. Manufactured by: Braintree Laboratories, Inc.
|
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued 06/2023
Principal Display Panel - Carton Label
NDC 52268-550-01
Dispense the enclosed Medication Guide to each patient.
SUFLAVE
(polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution)
178.7g/7.3g/1.12 g/0.9g/0.5g
2 Doses of SUFLAVE are required for a complete preparation.
This carton contains:
2 Flavor Enhancing Packets
2 Bottles
1 Patient booklet, which includes:
1. Instructions for Use
2. Full Prescribing Information
3. Medication Guide
© 2023 Braintree Labroatories, Inc. All rights reserved. 6/2023
Rx only
Braintree
A PART OF SEBELA PHARMACEUTICALS®
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Carton%20PDP.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Carton%20PDP.jpg)
Principal Display Panel - Bottle Label
NDC 52268-551-01
SUFLAVE(polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution)
178.7g/7.3g/1.12 g/0.9g/0.5g
Dispense the enclosed Medication Guide to each patient.
2 Doses of SUFLAVE are required for a complete preparation.
Rx only
Net Weight 188.73 g
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Bottle%20Label%20PDP.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Bottle%20Label%20PDP.jpg)
Principal Display Panel - Flavor Enhancing Packet
NDC 52268-552-01
SUFLAVE
For use with 1 SUFLAVE Bottle
This packet contains:
citric acid, anhydrous, USP, 0.820 g;
colloidal silicon dioxide, NF, 0.009 g;
malic acid, FCC, 0.718 g;
sucralose, FCC, 0.300 g.
Dispense the enclosed Medication Guide to each patient.
Net Weight 1.847 g
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Flavor%20Enhancing%20Packet%20PDP.jpg)
![](https://gcdrugs.s3.amazonaws.com/spl/546cfc44-791c-4524-99a9-6a0af96c4ec8/SUFLAVE%20Flavor%20Enhancing%20Packet%20PDP.jpg)