About RELISTOR

RELISTOR^® (methylnaltrexone bromide) works by treating the source of constipation caused by opioids without affecting the pain relief from opioid therapy. You and your doctor can continue to manage your pain with opioids while avoiding the constipation that often comes with opioid usage.

For help in restoring your BM experience to the activity you had prior to taking opioids, ask your doctor about RELISTOR.

RELISTOR delivers a reliable response in non-cancer chronic pain patients with opioid-induced constipation (OIC)

In a study, 59% of patients experienced at least 3 bowel movements per week (compared to 38% of patients receiving placebo or an inactive medicine).

Rapid OIC relief in patients with chronic non-cancer pain

In a study, 33% of patients taking RELISTOR experienced a bowel movement within 4 hours of their first dose (compared to 10% of patients receiving placebo).

RELISTOR delivers a rapid response from OIC in patients with pain from advanced illness

In studies^†, half of the patients who responded to RELISTOR^‡ experienced a bowel movement within 30 minutes. In one study, nearly half of RELISTOR patients experienced a bowel movement within 4 hours of their first dose (compared to 16% of patients taking placebo).

Side effects of RELISTOR

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.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of RELISTOR.

^†For both studies, patients maintained their regular laxative regimen for at least 3 days before beginning the study and throughout the study. Efficacy reported is for the study drug (either RELISTOR or placebo) + laxative regimen.
^‡Responders were RELISTOR patients experiencing a bowel movement within 4 hours of the first dose.

Indications

RELISTOR^® is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults:

with long-lasting (chronic) pain that is not caused by cancer.
receiving treatment for advanced illness, when other medicines for constipation have not worked well enough.
- It is not known if RELISTOR is safe and effective if used for longer than 4 months in people with advanced illness.

Important Safety Information

Do not take RELISTOR^® (methylnaltrexone bromide) Subcutaneous Injection if you have or may have a blockage in your intestines (called an intestinal obstruction) or a history of bowel blockage.

RELISTOR can cause serious side effects such as a tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that does not go away, stop taking RELISTOR and get emergency medical help right away.

Stop using RELISTOR and call your healthcare provider if you get diarrhea that is severe or that does not go away during treatment with RELISTOR.

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.

Tell your healthcare provider if you have kidney problems or if you have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome. Also, tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. 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: valeantmc@dlss.com

Click here for full Prescribing Information.

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