Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 Renal Impairment [see Warnings and Precautions ( 5.4 )] • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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 )] • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions ( 5.8 )] • Risks in Patients with Phenylketonuria [see Warnings and Precautions ( 5.9 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (>2%) are nausea, vomiting, dehydration and abdominal pain/discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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 Two-Day Split Dosage and One-Day Morning Dosage regimens was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials (Two-Day Split Dosage in the NOCT and MORA trials and One-Day Morning Dosage 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 ( 14 )].
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.
5 WARNINGS AND PRECAUTIONS • 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 impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing.
( 5.4 , 7.1 , 8.6 ) • Mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Like all medications, Plenvu can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: