RELISTOR® is for adult patients with opioid-induced constipation (OIC) and chronic non-cancer pain.

INDICATIONS

RELISTOR® (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.

  • RELISTOR tablets and RELISTOR injection are used to treat constipation caused by opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
  • RELISTOR injection is also used to treat constipation caused by opioids in adults with advanced illness or pain caused by active cancer and who need increases in their opioid dose for comfort care.

It is not known if RELISTOR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take RELISTOR if you have a bowel blockage (called an intestinal obstruction) or have a history of bowel blockage.

RELISTOR can cause serious side effects, including:

  • 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 is severe, does not go away, or gets worse, stop taking RELISTOR and get emergency medical help right away.
  • Diarrhea that is severe or that will not go 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.
  • Opioid withdrawal. 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.

Before you start taking RELISTOR, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems.
  • have liver problems.
  • have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
  • 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.
  • are breastfeeding or plan to breastfeed. 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 should not breastfeed during treatment with RELISTOR.

Also, tell your healthcare provider about all of the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements.

The most common side effects of RELISTOR tablets in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, diarrhea, headache, swelling or a feeling of fullness or pressure in your abdomen, sweating, anxiety, muscle spasms, runny nose, and chills.

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

You are encouraged to report side effects of prescription drugs to 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: 1-800-321-4576
Fax: 1-510-595-8183

Please see Important Safety Information throughout and click here for full Prescribing Information.

INDICATIONS

RELISTOR® (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.

  • RELISTOR tablets and RELISTOR injection are used to treat constipation caused by opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
  • RELISTOR injection is also used to treat constipation caused by opioids in adults with advanced illness or pain caused by active cancer and who need increases in their opioid dose for comfort care.

It is not known if RELISTOR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take RELISTOR if you have a bowel blockage (called an intestinal obstruction) or have a history of bowel blockage.

RELISTOR can cause serious side effects, including:

  • 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 is severe, does not go away, or gets worse, stop taking RELISTOR and get emergency medical help right away.
  • Diarrhea that is severe or that will not go 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.
  • Opioid withdrawal. 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.

Before you start taking RELISTOR, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems.
  • have liver problems.
  • have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
  • 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.
  • are breastfeeding or plan to breastfeed. 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 should not breastfeed during treatment with RELISTOR.

Also, tell your healthcare provider about all of the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements.

The most common side effects of RELISTOR tablets in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, diarrhea, headache, swelling or a feeling of fullness or pressure in your abdomen, sweating, anxiety, muscle spasms, runny nose, and chills.

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

You are encouraged to report side effects of prescription drugs to 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: 1-800-321-4576
Fax: 1-510-595-8183

Please see Important Safety Information throughout and click here for full Prescribing Information.