PLENVU

The plasma pharmacokinetic parameters for PEG 3350, ascorbate and sulfate are shown in Table 4.

Table 4Plasma Pharmacokinetic Data Following Two-Day Split Dosage 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 Subjects Four-day study with controlled diet including fasting from 2 pm on Day 1 to 2 pm on Day 2. (N=21) Product studied contains the same amount of PEG 3...

Study Design The colon cleansing efficacy, safety and tolerability of PLENVU was evaluated in two randomized, parallel-group, 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 ...

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 Renal Impairment [see Warnings and Precautions ( 5.4 )]
• Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions ( 5.5...

PLENVU is contraindicated in the following conditions:

• Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )]
• Bowel perforation [see Warnings and Precautions ( 5.6 )]
• Gastric retention
• Ileus
• Toxic megacolon
• Hypersensitivity to any ingredient in PLENVU [see Warnings and Precautions ( 5.10 )]
• Gastrointestinal (GI) obstruction ( 4 , 5.6 )
• Bowel perforation ( 4 , 5.6 ...

• Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1 , 5.2 , 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 seizure, including medications that lower the seizure threshold. ( 5.3 , 7.1 )
• Patients with renal impairme...

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. ( 7.1 ) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities 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 ...