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What is opioid-induced constipation?

Opioid-induced constipation (OIC), also called opioid constipation, is defined as a change in baseline bowel habits upon initiation of opioid therapy and includes any of the following5:

  • Decreased frequency
  • Straining
  • Incomplete evacuation
  • Harder stool consistency
What is opioid-induced constipation?

Opioid-induced constipation (OIC), also called opioid constipation, is defined as a change in baseline bowel habits upon initiation of opioid therapy and includes any of the following5:

  • Decreased frequency
  • Straining
  • Incomplete evacuation
  • Harder stool consistency

SYMPROIC® (naldemedine) addresses the underlying cause of OIC

SYMPROIC is a PAMORA that targets the underlying cause of opioid-induced constipation.2,6


SYMPROIC MOA

SYMPROIC® (naldemedine) addresses the underlying cause of OIC

SYMPROIC is a PAMORA that targets the underlying cause of opioid-induced constipation.2,6

It is not known if SYMPROIC is safe and effective in children.


SYMPROIC MOA

Is OIC getting in your patients’ way?

Digestive Tract Icon

Opioids bind to the mu-opioid receptors in the GI tract, which may lead to OIC4

Group of People Icon

About 40%-60% of patients receiving opioid therapy report developing OIC7

83% Icon

In a longitudinal study of 493 adults with chronic noncancer pain and OIC, 83% reported straining to pass bowel movements8

OTC Icon

Over-the-counter (OTC) laxatives do not address the underlying mechanism of OIC9

Learn about the proven efficacy of SYMPROIC for OIC

INDICATION

SYMPROIC® (naldemedine) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Important Safety Information

CONTRAINDICATIONS

  • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
  • Patients with a history of a hypersensitivity reaction to naldemedine. Reactions have included bronchospasm and rash.
INDICATION

SYMPROIC® (naldemedine) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Important Safety Information
CONTRAINDICATIONS
  • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
  • Patients with a history of a hypersensitivity reaction to naldemedine. Reactions have included bronchospasm and rash.
WARNINGS AND PRECAUTIONS

Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with SYMPROIC.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using SYMPROIC in such patients. Monitor for symptoms of opioid withdrawal in such patients.

DRUG INTERACTIONS

Avoid use with strong CYP3A inducers (e.g., rifampin) because they may reduce the efficacy of SYMPROIC.

Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase SYMPROIC concentrations. Monitor for potential adverse reactions.

Avoid use of SYMPROIC with another opioid antagonist due to the potential for additive effect and increased risk of opioid withdrawal.

USE IN SPECIFIC POPULATIONS

Naldemedine crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. SYMPROIC should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Avoid use in patients with severe hepatic impairment. No dose adjustment of SYMPROIC is required in patients with mild or moderate hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions with SYMPROIC compared to placebo in two pooled 12-week studies were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).

The incidence of adverse reactions of opioid withdrawal in two pooled 12-week studies was 1% (8/542) for SYMPROIC and 1% (3/546) for placebo. In a 52-week study, the incidence was 3% (20/621) for SYMPROIC and 1% (9/619) for placebo.

Please see Full Prescribing Information and Medication Guide for SYMPROIC.

To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-855-331-5615 or the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

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