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) ] Seizures [see Warnings and Precautions (5.2) ] Use in Patients with Renal Impairment [see Warnings and Precautions (5.3) ] Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Syncope [see Warnings and Precautions (5.5) ] Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions (5.6) ] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.7) ] Aspiration [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Adults (≥2%): nausea, headache, hypermagnesemia, abdominal pain and dehydration or dizziness.
( 6.1 ) Pediatrics 9 to 16 years (>5%): nausea, vomiting, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc.
at 1-888-FERRING (1-888-337-7464) 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 clinical trials of another drug and may not reflect the rates observed in practice.
Adults Clinical Study of CLENPIQ - Study 1 Table 1 displays the most common adverse reactions in a randomized, multicenter, assessor-blinded, non-inferiority trial of CLENPIQ for colon cleansing in adults (Study 1).
CLENPIQ was compared to another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product, both administered according to the Split-Dose dosage regimen [see Clinical Studies (14) ] .
Table 1: Common Adverse Reactions Observed in at Least 2% of Patients Undergoing Colon Cleansing in Study 1 Adverse Reaction Split-Dose Regimen CLENPIQ (N=448) % Sodium picosulfate, magnesium oxide, and anhydrous citric acid Powder for reconstitution (N=453) % Nausea 3 3 Headache 3 3 Hypermagnesemia Magnesium levels returned to normal within one week after colonoscopy in all patients in the CLENPIQ group.
2 5 Abdominal pain Abdominal pain included reports of abdominal pain, abdominal pain upper, and abdominal pain lower.
2 2 Dehydration or dizziness 2 2 Clinical Study of Another Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Product - Study 2 In a randomized, multicenter, investigator-blinded, active-controlled clinical trial for colon cleansing in adults, another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product was compared with a regimen of two liters (2 L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets (Study 2).
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmia, seizures, and renal impairment : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use.
( 5.1 , 5.2 , 5.3 , 5.4 , 7.1 ) Use in patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration, and consider testing.
( 4 , 5.3 , 7.1 ) Syncope : Resulted in serious outcomes including falls, head injuries, and fractures;
encourage adequate hydration.
( 5.5 ) Mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Like all medications, Clenpiq 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: