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

RELISTOR Vial and Syringe With Retractable Needle

Patient instructions for use

A retractable needle is one that automatically "pulls back" so that it is covered after use, to prevent needle-stick injury. You use a standard RELISTOR vial, and the syringe has lined marks that may make it easier for you to select the dose prescribed by your healthcare provider.

The following instructions explain how to prepare and give an injection of RELISTOR the right way when using a RELISTOR syringe with a retractable needle.

Before starting, read and make sure you understand the Patient Instructions for Use. Familiarize yourself with the RELISTOR tray, which contains the supplies you need for an injection. If you have any questions, talk to your healthcare provider. Your tray should include the following:

  1. RELISTOR vial
  2. 1-mL syringe with retractable needle (VanishPoint®)
  3. 2 alcohol swabs
  4. Prescribing Information—information about RELISTOR that is written for healthcare professionals
  5. Patient Instructions for Use of RELISTOR—instructions about RELISTOR that are written for patients

In addition, you will need a cotton ball or gauze, and you may need an adhesive bandage.

Important notes

  • Do not use a RELISTOR vial more than one time, even if there is medicine left in the vial
  • 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. For more information about how to store RELISTOR, see the section called "How should I store RELISTOR?" in the FDA-Approved Patient Labeling
  • Safely throw away RELISTOR vials after use
  • Do not reuse syringes or needles
  • To avoid needle-stick injuries, do not re-cap used needles
Choosing and preparing an injection site
  1. Subcutaneous injection sites on the abdomen, thighs, and armsChoose an injection site—abdomen, thighs, or upper arms. See shaded areas in the figure. Do not inject at the exact same spot each time (rotate injection sites). Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
    Abdomen or thigh—use these sites when injecting yourself or another person.
    Upper arm—use this site only when injecting another person.
  2. Picture showing how to apply pressure to the injection site with a cotton ballClean the injection site with an alcohol swab and let it air-dry. Do not touch this area again before giving the injection.
Preparing the injection
  1. Find a quiet place. Choose a flat, clean, well-lit working surface.
  2. Wash your hands with soap and warm water before preparing for the injection.
  3. Relistor vialLook at the vial of RELISTOR. The liquid in the vial should be clear and colorless to pale yellow and should not have any particles in it. If not, do not use the vial, and call your healthcare provider.
Preparing the syringe
  1. Picture showing how to remove the Relistor vial capRemove the cap from the RELISTOR vial.
  2. Image showing how to sterilize the vial capWipe the rubber stopper with an alcohol swab.
  3. Picture showing how to safely remove the needle cap on a standard syringeFirmly hold the barrel of the syringe and pull the needle cap straight off. Do not touch the needle or allow it to touch any surface.
  4. Picture a standard syringe barrel filling up while pulling back on the plungerCarefully pull back the plunger to the line that matches the dose prescribed by your healthcare provider. For most patients, this will be the 0.4-mL mark, which is an 8-mg dose, or the 0.6-mL mark, which is a 12-mg dose.
  5. Image showing how to insert the standard syringe needle into the vialInsert the needle straight down into the rubber top of the vial. Do not insert it at an angle. This may cause the needle to bend or break. You will feel some resistance as the needle passes through the rubber top.
  6. Image showing how to push the plunger down towards the vial to empty the air out of the syringeGently push down the plunger until all of the air is out of the syringe and has gone into the vial. Do not push past the resistance point. Doing this will make the needle retract (pull back) into the syringe barrel.
  7. Image showing how to slowly pull the plunger down with needle still in the fluidWith the needle still in the vial, turn the vial and syringe upside down. Hold the syringe at eye level. Make sure the tip of the needle is in the fluid. Slowly pull back on the plunger to the mark that matches your prescribed dose (usually the 0.4-mL mark, which is an 8-mg dose, or the 0.6-mL mark, which is a 12-mg dose).

    You may see some fluid or bubbles inside the vial when the syringe is filled. This is normal.
  8. Picture showing how to tap the side of the syringe to help remove air bubblesWith the needle still in the vial, gently tap the side of the syringe to make any air bubbles rise to the top.
  9. Picture showing how to tap the side of the syringe to help remove air bubblesSlowly push the plunger up until all air bubbles are out of the syringe.
  10. Image showing how to pull the plunger down to draw liquid into the syringeMake sure the tip of the needle is in the fluid. Slowly pull back the plunger to draw the right amount of liquid back into the syringe.

    Check to be sure that you have the right dose of RELISTOR in the syringe.

    Note: A small air bubble may stay in the syringe. This is okay and it will not affect the dose of medicine in the syringe.
  11. Slowly withdraw the needle from the vial. Do not touch the needle or allow it to touch any surface. Safely throw away the unused medicine in the vial. See step 5.
Injecting RELISTOR
  1. Picture showing how to pinch a fold of skin around the injection sitePinch the skin around the injection site.
  2. Image of syringe injection into the skin at  a 45-degree angleInsert the full length of the needle into the skin at a 45-degree angle with a quick "dart-like" motion.
  3. Image showing how to push the syringe plunger until the syringe is emptyLet go of the skin and slowly push down on the plunger past the resistance point, until the syringe is empty and you hear a click.
  4. Image demonstrating how the clicking sound means the retractable needle returned to the syringe barrelThe click sound means that the needle has been retracted (pulled back) into the barrel.
  5. Picture showing how to apply pressure to the injection site with a cotton ballHold a cotton ball or gauze over the injection site. Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.
Disposing of supplies
  1. Do not reuse a syringe or needle.
  2. Do not re-cap a used needle.
  3. Place used needles, syringes, and vials in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to throw away (dispose of) the container. There may be state and local laws about how you should throw away used needles and syringes.
  4. If you have any questions, talk to your healthcare provider or pharmacist.

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