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SYMPROIC® resources

Utilize the helpful resources below to learn more and to request SYMPROIC samples

SYMPROIC® resources

Utilize the helpful resources below to learn more and to request SYMPROIC samples

SYMPROIC resources

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Request samples

Request samples of SYMPROIC with our easy online form


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SYMPROIC dosing

Access dosing and administration details for SYMPROIC


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SYMPROIC clinical data

Learn more about the clinical data for SYMPROIC


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OIC dosing comparison

Compare the dosing and administration for oral products used to treat opioid-induced constipation


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AGA guidelines summary

Learn why the AGA guidelines rate SYMPROIC with both a strong recommendation and high quality of evidence


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For your patients

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Patient brochure

Provide your patients with important information about SYMPROIC


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Discussion guide

Help your patients talk about their OIC symptoms


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Patient Savings Card for SYMPROIC

Savings card

Visit the patient savings page to learn more


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About OIC

Learn more about the mechanism of opioid-induced constipation

About OIC

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Learn about the opioid constipation mechanism of disease

SYMPROIC MOA

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Learn more about the SYMPROIC mechanism of action

Transcript

Opioids are used to treat a wide variety of pain conditions, including chronic and cancer related pain. These therapies have proven analgesic efficacy that are associated with a number of adverse events, such as nausea, vomiting, and constipation. Opioid receptors are highly expressed within the spinal cord’s dorsal horn, which relays pain signals to the central nervous system and areas of the brain involved in pain transmission. Most opioids produce analgesia by binding to mu-opioid receptors within the central nervous system, including the dorsal horn of the spinal cord. This reduces neuronal excitability by impacting neurotransmission leading to an overall inhibitory effect on the neuron, resulting in pain relief. However, opioid receptors are also widely distributed throughout the peripheral nervous system, including the gastrointestinal system. Constipation in opiate users is a common adverse event resulting from the activation of mu-opioid receptors on neurons in the myenteric and submucosal plexuses of the enteric nervous system (ENS) within the GI tract.

This activation slows GI motility and reduces secretions into the gut lumen. This can lead to a distinct form of constipation called opioid-induced constipation (OIC). This consists in a change from baseline bowel habits characterized by any of the following:

  • Reduced bowel movement frequency
  • The development or worsening of straining to pass bowel movements
  • A sense of incomplete rectal evacuation
  • Harder stool consistency

Various pharmacological approaches are used to treat opioid-induced constipation, including over-the-counter laxatives and prescription medications, such as secretagogues and peripherally acting mu-opioid receptor antagonists (PAMORAs). However, PAMORAs, are a specifically targeted therapy that acts on the opioid receptor, reversing the constipating effects of opioid therapy.

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 BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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