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 Serious and important adverse reactions described elsewhere in labeling include: Gastrointestinal perforation [see Warnings and Precautions (5.1) ] Opioid withdrawal [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥2%) are: abdominal pain, diarrhea, nausea and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc.
at 1-800-469-0261 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 data described below reflect exposure to SYMPROIC in 1163 patients in clinical trials, including 487 patients with exposures greater than six months and 203 patients with exposures of 12 months.
The following safety data are derived from three double-blind, placebo-controlled trials in patients with OIC and chronic non-cancer pain: two 12-week studies (Studies 1 and 2) and one 52-week study (Study 3) [see Clinical Studies (14) ].
In Studies 1 and 2, patients on laxatives were required to discontinue their use prior to study enrollment.
All patients were restricted to bisacodyl rescue treatment during the study.
In Study 3, approximately 60% of patients in both treatment groups were on a laxative regimen at baseline;
patients were allowed to continue using their laxative regimen throughout the study duration.
The safety profile of SYMPROIC relative to placebo was similar regardless of laxative use.
5 WARNINGS AND PRECAUTIONS Gastrointestinal perforation : Consider the overall risk benefit in patients with known or suspected lesions of the GI tract.
Monitor for severe, persistent, or worsening abdominal pain;
discontinue if development of symptoms ( 5.1 ) Opioid withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier.
Monitor symptoms of opioid withdrawal ( 5.2 ) 5.1 Gastrointestinal Perforation Cases of gastrointestinal (GI) perforation have been reported with use of another peripherally acting opioid antagonist, including SYMPROIC.
Postmarketing cases of GI perforation, including fatal cases, were reported when SYMPROIC was used in patients at risk of GI perforation (e.g., GI cancer, past GI surgery, diverticulitis, chemotherapy/radiation).
Like all medications, Symproic 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: