Resources for Your Adult Patients With Opioid-Induced Constipation

The following online resources can help your patients find information and support. Some of these organizations may have a chapter in your area.

Advanced Illness Patient Resources

American Cancer Society (ACS)

www.cancer.org

The ACS provides information about current cancer research, grants, and awards, as well as information on national affairs, legislative updates, and community involvement. The ACS offers a wide range of patient education tools, such as treatment options and ways to stay healthy.

Food and Drug Administration (FDA)

www.fda.gov

The FDA provides information on foods and specific prescription drugs, safety alerts, recent product approvals, and more.

GetPalliativeCare.org

www.getpalliativecare.org

This website is sponsored by the Center to Advance Palliative Care (CAPC), a national organization dedicated to increasing the availability of palliative care services in hospitals and other health care settings. GetPalliativeCare.org offers a wide range of information, including articles, news stories, videos, and a provider directory.

Hospice Association of America (HAA)

www.nahc.org

HAA is a national organization representing thousands of hospices, caregivers, and volunteers who serve terminally ill patients and their families.

Hospice Patients Alliance (HPA)

www.hospicepatients.org

HPA provides information about hospice services, promotes better quality hospice care throughout the United States, and directly assists patients, families, and caregivers in resolving difficulties they may have with current hospice services.

Digestive Health Patient Resources

American College of Gastroenterology (ACG)

www.acg.gi.org

ACG provides consumer guides on various gastroenterological disorders and common problems, offers digestive health tips, and has a physician locator to find an ACG member in your area.

American Gastroenterological Association (AGA)

www.gastro.org

The public section of this website offers a digestive health resource, a gastroenterologist locator service, and various helpful online links.

National Digestive Diseases Information Clearinghouse (NDDIC)

www.digestive.niddk.nih.gov

NDDIC offers free publications about digestive diseases to patients and a phone inquiry line to answer your questions about educational materials.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

www.niddk.nih.gov

NIDDK provides information on various digestive diseases, health education programs, and clinical trials.

Chronic Pain Patient Resources

American Chronic Pain Association (ACPA)

www.theacpa.org

The ACPA offers pain management tools as well as other helpful materials for individuals seeking to improve the quality of their lives with chronic pain and for the professionals who help them.

The American Academy of Pain Medicine (AAPM)

www.painmed.org/patientcenter

AAPM offers helpful information to serve physicians who diagnose and treat pain patients, as well as provides general information about pain.

National Fibromyalgia & Chronic Pain Association (NFMCPA)

www.fmcpaware.org

The NFMCPA is an association that provides several resources on chronic pain, as well as a community to find support groups in your area.

American Pain Society (APS)

www.americanpainsociety.org

APS provides journals and other resources on pain management. Additionally, APS holds an annual educational meeting and webinars for an expanded educational experience.

US Pain Foundation

www.uspainfoundation.org

The US Pain Foundation helps individuals find resources and inspiration.

 

 

Indications

  • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
  • RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Limitations of Use: Use beyond four months has not been studied in the advanced illness population.

IMPORTANT SAFETY INFORMATION - RELISTOR tablets and RELISTOR injection

  • RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
  • Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
  • Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
  • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
  • A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.
  • In the clinical studies, the most common adverse reactions were:
    • OIC in adult patients with chronic non-cancer pain
      • RELISTOR tablets (≥2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
      • RELISTOR injection (≥1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).
    • OIC in adult patients with advanced illness
      • RELISTOR injection (≥5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%), flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

To report SUSPECTED ADVERSE REACTIONS, contact Salix at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch/

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.