RELISTOR Prefilled Syringe

The newly available RELISTOR prefilled syringe is available in 2 fixed doses and is ready to use. 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.

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

Patient instructions for use

Before starting, read and make sure you understand the Patient Instructions for Use. If you have any questions, talk to your healthcare provider.

Gather the supplies you will need for your injection. These include

  1. RELISTOR prefilled syringe
  2. Alcohol swab
  3. Cotton ball or gauze
  4. Adhesive bandage

Important notes

  • Do not use a RELISTOR prefilled syringe more than one time, even if there is medicine left in the syringe
  • Store RELISTOR pre-filled 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. 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 prefilled syringes after use (see step 4)
  • To avoid needle-stick injuries, do not recap used needles
  • Image showing the Trigger Fingers on a Relistor prefilled syringeAvoid touching the trigger fingers of the RELISTOR prefilled syringe to keep from activating the safety device too soon. The safety device (needle guard) is activated by pressure from the plunger on the trigger fingers
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 for prefilled syringe
  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. Picture of a prefilled syringe showing a yellow plunger rod for 8mg dose and dark blue rod for 12 mg doseLook at the prefilled syringe of RELISTOR. Make sure that the dose prescribed by your healthcare provider matches the dose on the prefilled syringe label. Look at the plunger rod of the syringe. If the dose prescribed by your healthcare provider is 8 mg, the plunger rod will be yellow; if the prescribed dose is 12 mg, the plunger rod of the syringe will be dark blue.
  4. The liquid in the prefilled syringe should be clear and colorless to pale yellow and should not have any particles in it. If not, do not use the prefilled syringe, and call your healthcare provider.
  5. Picture showing how to safely remove the needle cap on a prefilled syringeFirmly hold the barrel of the prefilled syringe and pull the needle cap straight off. Do not touch the needle or allow it to touch any surface.
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.

    Let go of the skin and slowly push down on the plunger with your thumb until the prefilled syringe is empty. This will release the needle safety device.
    Image showing how to push the syringe plunger until the syringe is empty
  3. Picture demonstrating how to remove your thumb from the syringe plunger to activate the protective sleeve for the needleContinue to hold pressure on the plunger with your thumb and quickly pull the needle out of the skin. Be careful to keep the needle at the same angle as it was inserted. Then remove your thumb from the plunger to allow the protective sleeve to cover the needle. There may be a little bleeding at the injection site.
  4. 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 the prefilled syringe or recap the needle. Place the used prefilled syringe 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.
  2. 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.