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

Taking RELISTOR

Talk with your doctor about the method that's best for you

The prefilled syringe comes already filled with the dose prescribed by your doctor, so you don't have to worry whether you've put the right amount of RELISTOR into it.

No matter how you take RELISTOR, it is injected just under the skin (a subcutaneous injection); it is not a "deep" or intramuscular (into the muscle) injection.

  • Prefilled syringe


    Picture of a prefilled syringe showing a yellow plunger rod for 8mg dose and dark blue rod for 12mg dose A syringe that comes prefilled with the dose prescribed by your healthcare provider. The prefilled syringe is color-coded, with a yellow plunger rod for an 8-mg dose and a dark blue plunger rod for a 12-mg dose.

    How to use a prefilled syringe

Here are some general questions that patients often ask about RELISTOR.1

For detailed, step-by-step instructions on how to inject RELISTOR, please click on one of the links above that matches the type of syringe that you will be using.

How should I take RELISTOR?
Subcutaneous injection sites on the abdomen, thighs, and arms
  • Take RELISTOR exactly as your healthcare provider tells you

Where?

  • Take RELISTOR by an injection under the skin (subcutaneous injection) of the upper arm, abdomen, or thigh

How often?

  • The usual dose schedule is once every other day, as needed, but not more than once in a 24-hour period

If you stop taking your prescription pain medicine, check with your healthcare provider before continuing RELISTOR. Also, if you take more RELISTOR than prescribed, talk to your healthcare provider right away.

Who should not take RELISTOR?

Do not take RELISTOR 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 before taking RELISTOR if you have any of these symptoms.

What should I tell my healthcare provider before taking RELISTOR?

Tell your healthcare provider about all of your medical conditions, including if you

  • Are pregnant or plan to become pregnant. It is not known if RELISTOR can harm your unborn baby. If you become pregnant while using RELISTOR, tell your healthcare provider right away
  • Are breast-feeding or plan to breast-feed. It is not known if RELISTOR passes into your breast milk
  • Have kidney problems
How should I store RELISTOR?
  • Store RELISTOR vials or prefilled syringes at 68°F to 77°F (20°C to 25°C)
  • Do not freeze RELISTOR
  • Keep RELISTOR away from light until you are ready to use it
  • If RELISTOR has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. The syringe does not need to be kept away from light during the 24-hour period

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.

Reference: 1. RELISTOR® (methylnaltrexone bromide) Prescribing Information, Salix Pharmaceuticals, Inc; 2012.