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SYMPROIC® (naldemedine) mechanism of action

SYMPROIC is different from OTC laxatives, targeting opioid-induced constipation at its source.5,6

SYMPROIC® (naldemedine) mechanism of action

SYMPROIC is different from OTC laxatives, targeting opioid-induced constipation at its source.5,6

How does SYMPROIC work?

SYMPROIC is2,6

  • A peripherally acting mu-opioid receptor antagonist (PAMORA)
  • An opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors
  • A substrate of the P-glycoprotein (P-gp) efflux transporter and designed to have reduced ability to cross the blood–brain barrier, thereby limiting its potential to interfere with centrally mediated opioid analgesia

SYMPROIC features2,6

SYMPROIC works by targeting OIC at its source in the gastrointestinal (GI) tract. With low rates of adverse events, including abdominal pain, SYMPROIC can help your patients go:

  • More often
  • More completely
  • With less straining
In clinical trials, patients taking SYMPROIC had low rates of abdominal pain. Learn more about the low rates of adverse events with SYMPROIC.SYMPROIC is contraindicated in patients with known or suspected gastrointestinal obstruction or at increased risk of recurrent obstruction and patients with a history of a hypersensitivity reaction to naldemedine.
Abdominal pain occurred in at least 8% of patients receiving SYMPROIC and at an incidence greater than placebo. Abdominal pain includes abdominal discomfort and pain in both the upper and lower abdomen.

SYMPROIC Tolerability

Results from clinical studies compared with placebo (sugar pill).Individual results may vary.

SYMPROIC features2,6

SYMPROIC works by targeting OIC at its source in the gastrointestinal (GI) tract. With low rates of adverse events, including abdominal pain, SYMPROIC can help your patients go:

  • More often
  • More completely
  • With less straining
In clinical trials, patients taking SYMPROIC had low rates of abdominal pain.

Learn more about the low rates of adverse events with SYMPROIC.

SYMPROIC is contraindicated in patients with known or suspected gastrointestinal obstruction or at increased risk of recurrent obstruction and patients with a history of a hypersensitivity reaction to naldemedine.

Abdominal pain occurred in at least 8% of patients receiving SYMPROIC and at an incidence greater than placebo. Abdominal pain includes abdominal discomfort and pain in both the upper and lower abdomen.

SYMPROIC Tolerability

Results from clinical studies compared with placebo (sugar pill).Individual results may vary.

Which OIC treatment does the AGA* recommend?

SYMPROIC is the only PAMORA with both a strong recommendation and high quality of evidence from the American Gastroenterological Association (AGA).3


During evaluations for these guidelines, naldemedine was the only prescription OIC treatment with long‑term, 52-week safety data from a double-blind, randomized, placebo-controlled safety study.3


*The American Gastroentrological Association (AGA) provides guidelines and recommendations for therapy for laxative-refractory OIC to help you determine the best treatment for patients.3

Save on SYMPROIC

Find out how to help your patients save on SYMPROIC and access the Patient Savings Card. Eligible commercially insured patients may pay as little as $0* for each prescription. Please see Program Terms, Conditions, and Eligibility Criteria, which include additional exclusions.


Help Patients Save
Symproic savings card with Symproic logo and “pay as little at $0*Maximum savings limit applies; patient’s out-of-pocket expenses may vary.

Read the SYMPROIC dosing and administration guidelines

SYMPROIC Dosing
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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