Indication for RELISTOR

RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) for adult patients with chronic non-cancer pain.

Important Safety Information about RELISTOR

Do not take RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection if you have or have had a bowel blockage (intestinal obstruction). Symptoms of this blockage are vomiting, stomach pain, and swelling of your abdomen. Talk to your healthcare provider if you have any of these symptoms before taking RELISTOR.

Cases of holes or openings in your gastrointestinal (GI) tract have been reported in adult patients with opioid-induced constipation and advanced illness with certain conditions (i.e., stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome). These holes or openings have involved varying regions of the GI tract (e.g., stomach or intestines). Use RELISTOR with caution if you have a known or suspected wound or injury to the GI tract. If you get abdominal pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider.

If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider.

You may have symptoms of opioid withdrawal during treatment with RELISTOR including sweating, chills, diarrhea, stomach pain, anxiety, and yawning. Tell your healthcare provider if you have any of these symptoms.

Taking RELISTOR during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with RELISTOR.

It is not known if RELISTOR passes into your breast milk. Taking RELISTOR while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take RELISTOR or breastfeed. You should not do both.

The most common side effects of RELISTOR in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, nausea, diarrhea, sweating, hot flush, tremor, and chills.

The most common side effects of RELISTOR in people receiving treatment for their advanced illness include: stomach-area (abdomen) pain, gas, nausea, dizziness, and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for RELISTOR.

REL65-0814

Helpful Websites

If you are living with an advanced illness, it can be comforting to seek understanding and support from loved ones, healthcare professionals, and support groups.

The following list of helpful websites and other online resources can help. On these sites, you can learn about organizations where you can find more information and support. Some may have a local chapter in your area.

Advanced illness

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

Digestive health

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.

Indication for RELISTOR

RELISTOR® is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.

Important Safety Information about RELISTOR

Do not take RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection if you have or may have a blockage in your intestines called a mechanical bowel obstruction. Symptoms of this blockage are vomiting, stomach pain, and swelling of your abdomen. Talk to your healthcare provider if you have any of these symptoms before taking RELISTOR.

Cases of holes or openings in your gastrointestinal (GI) tract have been reported in adult patients with opioid-induced constipation and advanced illness with certain conditions (i.e., cancer, peptic ulcer, Ogilvie's syndrome). These holes or openings have involved varying regions of the GI tract (e.g., stomach or intestines). Use RELISTOR with caution if you have a known or suspected wound or injury to the GI tract. If you get abdominal pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider.

If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider.

Use of RELISTOR beyond four months has not been studied.

Safety and efficacy of RELISTOR have not been established in children.

The most common side effects of RELISTOR in clinical studies include: abdominal (stomach) pain, gas, nausea, dizziness, diarrhea, and sweating.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for RELISTOR.