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PLENVU®
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) for Oral Solution
The active ingredients contained in PLENVU are provided in Table 3.
Table 3: Details of Active Ingredients contained in PLENVU
| Chemical Name | Chemical Formula | Average Molecular Weight (g/mol) | Chemical Structure | |
| Polyethylene Glycol (PEG) 3350 | H-(OCH2-CH2)n-OH | 3350 |
|
|
| Sodium Ascorbate | C6H7NaO6 | 198.1 |
|
|
| Sodium Sulfate | Na2SO4 | 142.0 |
|
|
| Ascorbic Acid | C6H8O6 | 176.1 |
|
|
| Sodium Chloride | NaCl | 58.4 | Na+ Cl- | |
| Potassium Chloride | KCl | 74.6 | K+ Cl+ |
PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution.
Dose 1 contains 100 grams of PEG 3350, NF; 9 grams of sodium sulfate, NF; 2 grams of sodium chloride, USP/NF; and 1 gram of potassium chloride, USP/NF; and the following excipients: sucralose, NF; encapsulated citric acid; and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor.
Each Dose 2 Pouch A contains 40 grams of PEG 3350, NF; 3.2 grams of sodium chloride, USP/NF; and 1.2 grams of potassium chloride, USP/NF and the following excipients: aspartame, NF and fruit punch flavoring.
Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate, USP/NF; and 7.54 grams of ascorbic acid, USP/NF.
When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor.
The entire, reconstituted, 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings.
A mixing container for reconstitution is enclosed.
Contains Phenylalanine 491 mg per treatment.
Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).
PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.
Two doses of PLENVU are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure [see Two-Day Split-Dosing Regimen and One-Day Morning Dosing Regimen].
The Two-Day Split-Dosing Regimen commences in the evening of the day before the colonoscopy.
Instruct adult patients that on the day before the clinical procedure, they can consume a light breakfast followed by a light lunch, which must be completed at least 3 hours prior to the start of the first PLENVU dose.
Instruct patients to take two separate doses in conjunction with clear liquids as follows:
Dose 1 – In the evening before the colonoscopy, between approximately 4 pm and 8 pm:
Dose 2 – The next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 (between approximately 4 am and 8 am):
Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.
The One-Day Morning Dosing Regimen commences in the morning of the day of the colonoscopy.
Instruct adult patients that on the day before the clinical procedure, they can consume a light breakfast followed by a light lunch, and clear broth soup and/or plain yogurt for dinner, which should be completed by approximately 8 pm.
Instruct patients to take two separate doses in conjunction with clear liquids as follows:
Dose 1 – On the day of the colonoscopy, between approximately 3 am and 7 am:
Dose 2 – On the day of the colonoscopy, a minimum of 2 hours after the start of Dose 1:
Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.
After reconstitution, keep PLENVU solution at room temperature, between 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. The solution may also be stored in a refrigerator. Use within 6 hours after it is mixed in water.
PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution.
First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B.
PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution.
Dose 1 contains 100 grams of PEG 3350, NF; 9 grams of sodium sulfate, NF; 2 grams of sodium chloride, USP/NF; and 1 gram of potassium chloride, USP/NF: NDC 65649-400-01.
Dose 2 Pouch A contains 40 grams of PEG 3350, NF; 3.2 grams of sodium chloride, USP/NF; and 1.2 grams of potassium chloride, USP/NF: NDC 65649-400-01.
Dose 2 Pouch B contains 48.11 grams of sodium ascorbate, USP/NF; and 7.54 grams of ascorbic acid, USP/NF: NDC 65649-400-01.
PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 65649-400-01.
PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 65649-400-01.
Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.
Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. Manufactured by: Norgine Limited, 7 Tir-y-berth Industrial Estate, New Road, Tir-y-berth, Hengoed, CF82 8SJ, United Kingdom (GBR). Revised: May 2018
The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:
Because clinical trials 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.
The safety of PLENVU as a Two-Day Split-Dosing and One-Day Morning Dosing Regimen was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials (Two-Day Split-Dosing in the NOCT and MORA trials and One-Day Morning Dosing in the MORA trial) in 1351 adult patients undergoing colonoscopy. The mean age of the study population was 56 years (range 18 to 86 years), 92% of patients were Caucasian and 51% were female. In the NOCT trial, 61% of patients had mild renal impairment. In the MORA trial, 67% had mild renal impairment and 5% had moderate renal impairment. Patients with severe renal impairment were not enrolled in the clinical trials of PLENVU [see Clinical Studies].
The most common adverse reactions (>2%) in the PLENVU treatment groups in both trials were: nausea, vomiting, dehydration and abdominal pain/discomfort.
Table 1 and Table 2 display adverse reactions reported in at least 1% of patients in one or more treatment group(s) in the NOCT and MORA trials, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials.
Table 1: Common Adverse Reactions* in Patients
Undergoing Colonoscopy in the NOCT Trial by Treatment Group
| Preferred Term | PLENVU Two-Day Split Dosing Regimen (N = 275) % |
Trisulfate1 Two-Day Split Dosing Regimen (N = 271) % |
| Nausea | 7 | 2 |
| Vomiting | 6 | 3 |
| Dehydration2 | 4 | 2 |
| Abdominal Pain/Discomfort3 | 2 | 2 |
| Decline in Glomerular Filtration Rate (GFR)4 | 2 | 2 |
| Electrolyte Abnormalities5 | 2 | 1 |
| Fatigue | 2 | 1 |
| Headache | 2 | 1 |
| Abdominal Distension | 1 | 1 |
| Gastritis | 1 | 1 |
| Hiatus Hernia | 1 | 0 |
| Nasopharyngitis | 1 | 1 |
| * Reported in at least 1% of patients in either treatment
group N = Total number of patients in the treatment group; n = the number of patients with the adverse reaction 1 Trisulfate: Two 6 ounce bottles of oral solution each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams 2 Includes signs and symptoms of dehydration, including dizziness, dry mouth, orthostatic hypotension, pre-syncope, syncope, and thirst 3 Includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness 4 Decreased or abnormal GFR 5 Includes increased anion gap, decreased blood bicarbonate, hypomagnesemia, hyperosmolarity, hypokalemia, hyperkalemia, hypercalcemia, hypernatremia, hyperosmolar state, hyperuricemia, hypocalcemia, and hypophosphatemia |
||
Table 2: Common Adverse Reactions* in Patients
Undergoing Colonoscopy in the MORA Trial by Treatment Group
| Preferred Term | PLENVU One-Day Morning Dosing Regimen (N = 271) % |
PLENVU Two-Day Split Dosing Regimen (N = 265) % |
2 Liter PEG + Electrolytes Two-Day Split-Dosing Regimen1 (N = 269) % |
| Vomiting | 7 | 4 | 1 |
| Nausea | 6 | 6 | 3 |
| Dehydration2 | 4 | 3 | 2 |
| Abdominal Pain/Discomfort3 | 3 | 2 | 3 |
| Hypertension | 2 | 1 | 0 |
| Headache | 1 | 2 | 2 |
| Electrolyte Abnormalities4 | 1 | 1 | 0 |
| * Reported in at least 1% of patients in either treatment
group N = Total number of patients in the treatment group; n = the number of patients with the adverse reaction 1 2 Liter PEG Plus Electrolytes: Two doses each containing PEG 3350 100 grams, sodium sulfate 7.5 grams, sodium chloride 2.691 grams, potassium chloride 1.015 grams, sodium ascorbate 5.9 grams, and ascorbic acid 4.7 grams 2 Includes signs and symptoms of dehydration, including dizziness, dry mouth, orthostatic hypotension, pre-syncope, syncope, and thirst 3 Includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness 4 Includes increased anion gap, decreased blood bicarbonate, hypomagnesemia, increased blood osmolarity, hypokalemia, hyperkalemia, hypercalcemia, hypernatremia, hyperosmolar state, hyperuricemia, hypocalcemia, and hypophosphatemia |
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Increases in serum sodium, chloride, calcium, magnesium, phosphate, and urate were noted in more patients treated with PLENVU compared with control in one or both trials. The majority of these changes were transient and not clinically significant. Associated decreases in bicarbonate and increases in serum osmolality were also noted.
Decreases in creatinine clearance and increases in blood urea nitrogen (BUN) were also noted in more patients treated with PLENVU compared to control in both trials. Changes of a magnitude indicative of possible acute renal injury, or worsening of baseline chronic renal impairment, were noted infrequently and occurred at a similar incidence in both PLENVU and comparator arms.
Adverse reactions in patients with mild renal impairment were similar to those in patients with normal renal function.
Less common adverse reactions (less than 1%) in the NOCT and MORA trials include: anorectal discomfort, hypersensitivity reaction (including rash), migraine, somnolence, asthenia, chills, pains, aches, palpitation, sinus tachycardia, hot flush, and transient increase in liver enzymes.
An additional 235 patients were exposed to the One-Day Morning Dosing Regimen of PLENVU in a third clinical trial, utilizing a comparator not approved in the United States. The adverse reaction profile for patients receiving PLENVU in that trial was similar to what is described above.
The following adverse reactions have been identified during post-approval use of another oral formulation of polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride or other polyethylene glycol (PEG)-based bowel preparations. 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.
Hypersensitivity: urticaria/rash, pruritus, dermatitis, rhinorrhea dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see CONTRAINDICATIONS]
Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration
Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]
Nervous system: tremor, seizure
Use caution when prescribing PLENVU for patients with conditions and/or who are using medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS].
Consider additional patient evaluations as appropriate.
PLENVU can reduce the absorption of other coadministered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of PLENVU[see DOSAGE AND ADMINISTRATION].
Concurrent use of stimulant laxatives and PLENVUmay increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PLENVU[see WARNINGS AND PRECAUTIONS].
Included as part of the PRECAUTIONS section.
Advise patients to hydrate adequately before, during, and after the use of PLENVU. If a patient develops significant vomiting or signs of dehydration after taking PLENVU, consider performing post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN).
Bowel Preparations can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment. Correct fluid and electrolyte abnormalities before treatment with PLENVU. PLENVU should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)] [see DRUG INTERACTIONS]. Consider performing pre-dose and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in patients receiving these concomitant medications.
There have been rare reports of serious arrhythmias (including atrial fibrillation) 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 PLENVU 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, cardiomyopathy or electrolyte imbalance). Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
There have been rare 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 PLENVUfor 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 PLENVUwith caution in patients with renal impairment or patients taking concomitant medications that affect renal function (such as diuretics, ACE inhibitors, angiotensin receptor blockers, or nonsteroidal antiinflammatory drugs) [see DRUG INTERACTIONS]. 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 PLENVU, and consider performing pre-dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use In Specific Populations].
Osmotic laxatives 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 PLENVU may increase the risk and is not recommended. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PLENVU [see CONTRAINDICATIONS]. Use with caution in patients with severe ulcerative colitis.
Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of PLENVU. Observe these patients during the administration of PLENVU. Use with caution in these patients.
Since PLENVU contains sodium ascorbate and ascorbic acid, PLENVU should be used with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, especially G6PD deficiency patients with an active infection, with a history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions.
Phenylalanine can be harmful to patients with phenylketonuria (PKU). PLENVUcontains phenylalanine, a component of aspartame. Each PLENVU treatment contains 491 mg of phenylalanine. Before prescribing PLENVU to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including PLENVU.
PLENVUcontains PEG and 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 with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU.
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 data available to assess the presence of PLENVU in human milk, the effects on the breastfed child or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PLENVU to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PLENVU and any potential adverse effects on the breastfed child from PLENVU or from the underlying maternal condition.
The safety and effectiveness of PLENVU in pediatric patients has not been established.
Of the approximately 1000 patients in clinical trials receiving PLENVU, 217 (21%) patients were over 65 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, elderly 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].
Use PLENVU with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see DRUG INTERACTIONS]. 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 PLENVU, 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 PLENVU 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.
PLENVU is contraindicated in the following conditions:
The primary mode of action is osmotic action of the components of PLENVU (PEG 3350 plus sodium sulfate components in Dose 1, and sodium ascorbate and ascorbic acid plus PEG 3350 components in Dose 2) which induce the laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.
The osmotic effect of the unabsorbed PEG, ascorbate and sulfate ions, when ingested, produces a copious watery diarrhea.
The first bowel movement may happen about 1 to 2 hours after the start of PLENVU intake.
The plasma pharmacokinetic parameters for PEG 3350, ascorbate and sulfate are shown in Table 4.
Table 4: Plasma Pharmacokinetic Data Following Two-Day
Split-Dosing Regimen of 140 grams PEG 3350, 33.9 grams Sodium Ascorbate, 9
grams Sodium Sulfate, 20.1 grams Ascorbic Acid, 4.8 grams Sodium Chloride and
2.3 grams Potassium Chloride in Healthy Subjects1 (N=21)2
| PK Parameter | PEG 3350 Mean (SD) | Ascorbate3 Mean (SD) | Sulfate3 Mean (SD) |
| Cmax [mcg/mL] | 2.7 (1.17) | 70.8 (22.37) | 17.6 (4.80) |
| tmax [h] | 3.0 (0.61) | 16.8 (0.75) | 8.1 (5.51) |
| AUC(0-tlast) [(mcg/mL)*h] |
17.3 (7.19) | 433.1 (157.29) | 206.2 (74.32) |
| Vd [l] | 48,481 (29,811) | 1,026 (675) | 231 (205) |
| t½ [h] | 4.1 (2.34) | 7.2 (6.16) | 10.5 (15.19) |
| 1 Four-day study with controlled diet
including fasting from 2 pm on Day 1 to 2 pm on Day 2. 2 Product studied contains the same amount of PEG 3350 and sodium sulfate, although the amount of sodium ascorbate and ascorbic acid are slightly different, compared to PLENVU. SD = standard deviation; Cmax = maximum concentration; tmax = time to maximum concentration from start of dosing; AUC(0-tlast) = area under the curve from t0 to tlast; Vd = volume of distribution; t½ = half-life. 3 Baseline-corrected |
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A pharmacokinetic study measured up to 85% to 99% of a 140 grams oral PEG 3350 dose in excreted feces. A pharmacokinetic study measured up to 69% of a 50 grams oral ascorbate dose in excreted feces and up to 5% of the 50 grams oral ascorbate dose is recovered in the urine (with up to 0.07% as the ascorbate metabolite, oxalic acid).
Sulfate is endogenous and also present in the diet. A pharmacokinetic study measured up to 69% to 73% of a 9 grams oral sodium sulfate dose in excreted feces, with approximately 43% recovered in the urine.
The colon cleansing efficacy, safety and tolerability of PLENVU was evaluated in two randomized, parallelgroup, multicenter, investigator-blinded trials in adult patients scheduled to undergo a screening, surveillance, or diagnostic colonoscopy. The overall patient population consisted of 49% male and 51% female patients, mean age of 56 years (range 18 to 86 years), 92% Caucasian, 5% Black and 2% Asian. In general, the demographic characteristics were balanced across the trials.
In Study NER1006-01/2014 (referred to as NOCT; NCT02254486) and Study NER1006-02/2014 (referred to as MORA; NCT02273167), the bowel cleansing efficacy of PLENVU was compared to two different comparators (Table 5) using two different PLENVU dosing regimen(s):
Table 5: Treatment Regimens by Trial
| Trial | PLENVU Regimen(s) | Comparator Regimens |
| NOCT | Two-Day Split-Dosing | Trisulfate bowel cleansing solution administered as a Two-Day Split-Dosing Regimen:
|
| MORA | Two-Day Split-Dosing and One-Day Morning Dosing | 2 liter PEG + electrolytes (2 L PEG+E) preparation administered as a Two-Day Split-Dosing Regimen:
|
The primary efficacy endpoint in both trials was the proportion of patients achieving “overall bowel cleansing success,” which was defined by a result of Grade A or B (Grades A or B [see Table 6] corresponding to full visualization of the bowel mucosa on the Harefield Cleansing Scale [HCS]), as assessed on withdrawal of colonoscope. The HCS segmental scores were initially evaluated by the colonoscopist at the site, who was blinded to treatment, and evaluated for endpoint analysis by central readers (gastroenterologists) using video recordings of the colonoscopy.
Table 6: Harefield Cleansing Scale
| Overall Grade | Description |
| A | All five segments* scored 3 or 4 (Mucosa is fully visualized without cleaning.) |
| B | One or more segments scored 2, remaining segments scored 3 or 4 (Mucosa is fully visualized.) |
| C | One or more segments scored 1, remaining segments scored 2, 3 or 4 |
| D | One or more segments scored 0 |
| Segmental Score | Description |
| 4 | Empty and clean |
| 3 | Clear liquid |
| 2 | Brown liquid/fully removable semisolid stools |
| 1 | Semisolid, only partially removable stools |
| 0 | Irremovable, heavy, hard stools |
| * Colon ascendens, Colon transversum, Colon descendens, Colon sigmoideum, Rectum | |
The modified Intent-to-Treat (mITT) population was used as the primary population for the efficacy analyses and was defined as all randomized patients with the exception of any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Non-inferiority was assessed using a one-sided 97.5% confidence interval (CI) for the difference in proportions of patients for the overall bowel cleansing success endpoint. Non-inferiority was demonstrated if the difference between PLENVU and the comparator was above the predefined non-inferiority margin set at -10%.
The results for the overall bowel cleansing success endpoint in the mITT population in NOCT are shown in Table 7. The Two-Day Split-Dosing regimen of PLENVU was shown to be non-inferior (NI) to the trisulfate solution comparator.
Table 7: Overall Bowel Cleansing Success Rate of
PLENVU versus Trisulfate in NOCT
| Primary Endpoint (N=556) |
PLENVUTwo-Day Split-Dosing (N=276) n (% = n/N*100) |
TrisulfateTwo-Day Split-Dosing (N=280) n (% = n/N*100) |
PLENVU® - Trisulfate Difference (%) (97.5% One-Sided Lower Confidence Interval) |
| Overall Colon | 235 | 238 | 0 1% |
| Cleansing Success Rate | (85.1%) | (85.0%) | (-8.2%) |
The results for the overall bowel cleansing success endpoint in the mITT population in MORA are shown in Table 8. Both the PLENVU Two-Day Split-Dosing regimen and the PLENVU One-Day Morning Dosing regimen were shown to be non-inferior (NI) to the 2 L PEG+E treatment comparator.
Table 8: Overall Bowel Cleansing Success Rate of
PLENVU versus 2 L PEG+E in MORA
| Primary Endpoint (N=822) |
PLENVU Two-Day Split-Dosing (N=275) n (% = n/N*100) |
PLENVU One-Day Morning Dosing (N=275) n (% = n/N*100) |
2 L PEG+E Two-Day Split-Dosing (N=272) n (% = n/N*100) |
PLENVU® Regimen - 2 L PEG+E Difference (%) (97.5% One-Sided Lower Confidence Interval) |
| Overall Colon Cleansing Success Rate | 253 (92.0%) | 245 (89.1%) | 238 (87.5%) | Two-Day Split-Dosing 4.5% (-4.0%) One-Day Morning Dosing 1.6% (-6.9%) |
PLENVU®
(plen-vu)
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic
acid, sodium chloride and potassium chloride for oral solution)
Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PLENVU.
What is the most important information I should know about PLENVU?
PLENVU and other bowel preparations can cause serious side effects, including:
Your chance of having fluid loss and changes in body salts with PLENVU is higher if you:
Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking PLENVU:
See “What are the possible side effects of PLENVU?” for more information about side effects.
What is PLENVU?
PLENVU is a prescription medicine used by adults to clean the colon before a colonoscopy. PLENVU 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 PLENVU is safe and effective in children.
Do not take PLENVU if your healthcare provider has told you that you have:
Before taking PLENVU, tell your healthcare provider about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
PLENVU may affect how other medicines work. Do not take medicines by mouth 1 hour before or after the start of PLENVU.
Especially tell your healthcare provider if you take:
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 PLENVU?
See the “Instructions for Use” for dosing instructions. You must read, understand, and follow these instructions to take PLENVU the right way.
What are the possible side effects of PLENVU?
PLENVU can cause serious side effects including:
The most common side effects of PLENVU include:
These are not all the possible side effects of PLENVU.
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 PLENVU?
Keep PLENVU and all medicines out of the reach of children.
General information about the safe and effective use of PLENVU.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PLENVU for a condition for which it was not prescribed. Do not give PLENVU 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 healthcare professionals.
What are the ingredients in PLENVU?
Active ingredient:
Dose 1: PEG 3350, sodium sulfate, sodium chloride, potassium chloride
Dose 2 Pouch A: PEG 3350, sodium chloride, potassium chloride
Dose 2 Pouch B: sodium ascorbate, ascorbic acid
Inactive ingredients:
Dose 1: sucralose, encapsulated citric acid, mango flavoring
Dose 2 Pouch A: aspartame, fruit punch flavoring
Instructions for Use
PLENVU®
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid,
sodium chloride and potassium chloride for oral solution)
There are two different options for taking PLENVU. Your healthcare provider will tell you to take the Two-Day Split-Dosing option or the One-Day Morning Dosing option.
The following are provided with the pack:
 |
 |
 |
The inner carton contains:
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Additional supplies:
Important Information on PLENVU:
It is important for you to drink the additional amount of clear liquids listed here in the Instructions for Use.
Examples of clear liquids are:
Two-Day Split-Dosing Schedule
Take Dose 1 in the evening sometime between 4 pm and 8 pm.
Take Dose 2 the next morning, on the day of the colonoscopy. This should be about 12 hours (between about 4 am and 8 am) after you started Dose 1. Make sure you finish Dose 2 at least 2 hours before your colonoscopy.
Follow steps 1 through 3 on how to mix with a spoon or shake with lid on securely and take PLENVU:
Step 1a: Empty Dose 1 into the mixing container that comes with your PLENVU.
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Step 1b: Add water to the fill line. You will need to add least 16 ounces.
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Step 1c: Mix the water and PLENVU together with a spoon or put lid on mixing container securely and shake the water and PLENVU, until it is completely dissolved. This can take 2 to 3 minutes.
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Step 2: Drink the entire contents of the mixing container over the next 30 minutes.
If you feel like you have severe stomach pain or discomfort you can stop taking PLENVU for a short time and then continue taking it or you can take smaller sips of PLENVU so that you space out your dose longer than 30 minutes. If you still have severe stomach pain, call your healthcare provider.
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Step 3: Rinse the mixing container with water. Refill to the fill line with clear liquids. This will be at least 16 ounces. Drink the entire contents of the mixing container over the next 30 minutes. Continue to drink additional clear liquids during the evening. For a list of clear liquids, see examples at the top of the Instructions for Use.
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After taking PLENVU if you have any bloating or feeling like your stomach is upset, wait to take Dose 2 until your stomach feels better.
For Dose 2: Rinse the mixing container with water. Repeat Steps 1, 2 and 3 but this time for Dose 2 you will empty two dose pouches (Dose 2 Pouch A and Dose 2 Pouch B) into the mixing container at the same time. It is important that you drink additional clear liquids, but you must stop drinking all liquids 2 hours before your colonoscopy.
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One-Day Morning Dosing Schedule
Take Dose 1 the morning of your colonoscopy sometime between 3 am and 7 am.
Take Dose 2 about two hours after you start Dose 1. Make sure you finish Dose 2 at least 2 hours before your colonoscopy.
Follow the steps 1 through 3 on how to mix with a spoon or shake with lid on securely and take PLENVU:
Step 1a: Empty Dose 1 into the mixing container that comes with your PLENVU.
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Step 1b: Add water to the fill line. You will need to add least 16 ounces.
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Step 1c: Mix the water and PLENVU together with a spoon or put lid on mixing container securely and shake the water and PLENVU, until it is completely dissolved. This can take 2 to 3 minutes.
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Step 2: Drink the entire contents of the mixing container over the next 30 minutes.
If you feel like you have severe stomach pain or discomfort you can stop taking PLENVU for a short time and then continue taking it or you can take smaller sips of PLENVU so that you space out your dose longer than 30 minutes. If you still have severe stomach pain, call your healthcare provider.
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Step 3: Rinse the mixing container with water. Refill to fill line with clear liquids. This will be at least 16 ounces. Drink the entire contents of the mixing container over the next 30 minutes. For a list of clear liquids, see examples at the top of the Instructions for Use.
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After taking PLENVU if you have any bloating or feeling like your stomach is upset, wait to take Dose 2 until your stomach feels better.
For Dose 2: Rinse the mixing container with water. Repeat Steps 1, 2 and 3 but this time for Dose 2 you will empty two dose pouches (Dose 2 Pouch A and Dose 2 Pouch B) into the mixing container at the same time. It is important that you drink additional clear liquids, but you must stop drinking all liquids 2 hours before your colonoscopy.
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This Instructions for Use has been approved by the U.S. Food and Drug Administration.
