Patient information: uses, side effects, how to take - Relistor

What is the most important information I should know about RELISTOR?

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 taking 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.

What is RELISTOR?

RELISTOR 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 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.

Who should not use RELISTOR?

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

What should I tell my healthcare provider before taking RELISTOR?

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.

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

How should I take RELISTOR?

Stay close to a toilet after taking RELISTOR.
Stop taking RELISTOR if you stop taking your prescription opioid pain medicine. Tell your healthcare provider if your pain medicine changes.
If you take too much RELISTOR, call your healthcare provider or go to the nearest emergency room right away.
If you take RELISTOR for long-lasting (chronic) pain that is not caused by cancer:
RELISTOR has been shown to be effective in people who have taken opioid pain medicines for at least 4 weeks to treat long-lasting (chronic) pain not caused by cancer.
Stop taking other laxatives before you start treatment with RELISTOR. You may use other laxatives if RELISTOR does not work after 3 days of treatment.

Tablets:

Take RELISTOR tablets 1 time each day with water. Take RELISTOR tablets on an empty stomach at least 30 minutes before your first meal of the day.

Injection (Vials and Pre-filled Syringes):

See the detailed “Instructions for Use” that comes with RELISTOR injection for information about how to prepare and inject RELISTOR injection, and properly throw away (dispose of) used needles and syringes the right way.

RELISTOR injection is injected under the skin (subcutaneous injection) of the upper arm, stomach-area (abdomen), or thigh.
Inject RELISTOR injection exactly as your healthcare provider tells you.
If you use RELISTOR injection for long-lasting (chronic) pain that is not caused by cancer:
Inject 1 dose of RELISTOR injection each day.
If you use RELISTOR injection and are receiving treatment for advanced illness:
Inject 1 dose of RELISTOR injection every other day, as needed. You should not inject more than 1 dose of RELISTOR injection in a 24-hour period.

What are the possible side effects of RELISTOR?

See “What is the most important information I should know about RELISTOR?”

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.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Salix Pharmaceuticals at 1-800-321-4576.

How should I store RELISTOR?

RELISTOR tablets:

Store RELISTOR tablets at room temperature between 68° to 77°F (20° to 25°C).
The bottle of RELISTOR tablets contains 2 desiccant canisters to help keep your medicine dry. Do not remove the desiccant canisters from the bottle.

RELISTOR injection (Vials and Pre-filled Syringes):

Store RELISTOR vials and pre-filled syringes at room temperature between 68° to 77°F (20° to 25°C).
Do not freeze RELISTOR vials or pre-filled syringes.
Keep RELISTOR vials and pre-filled syringes away from light until you are ready to use them.
If the contents of a RELISTOR vial have been drawn into a syringe and you are not able to use the medicine right away, keep the syringe at room temperature for up to 24 hours.

Keep RELISTOR and all medicines, needles and syringes out of the reach of children.

General information about the safe and effective use of RELISTOR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RELISTOR for a condition for which it was not prescribed. Do not give RELISTOR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RELISTOR that is written for health professionals.

What are the ingredients in RELISTOR tablets and RELISTOR injection?

Active ingredient: methylnaltrexone bromide

Inactive ingredients (tablets): silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc

Inactive ingredients (injection: vials and pre-filled syringes): sodium chloride USP, edetate calcium disodium USP, glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

Distributed by:

Salix Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Under license from:

Progenics Pharmaceuticals, Inc.

Tarrytown, NY 10591 USA

For Injection: Patented. See https://patents.salix.com for US patent information.

For Tablets: Patented. See https://patents.salix.com for US patent information.

For more information, go to www.RELISTOR.com or call 1-800-321-4576.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: May 2024

9502506

70014843-01

Instructions for Use – Pre-filled Syringe

INSTRUCTIONS FOR USE

RELISTOR^®(rel-i-store)

(methylnaltrexone bromide)

injection, for subcutaneous use

Pre-filled Syringe

Read this Instructions for Use before you start using RELISTOR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

Important information:

Do not use a RELISTOR pre-filled syringe and attached needle more than 1 time, even if there is medicine left in the syringe. See Step 4 “Dispose of used pre-filled syringes and needles.”
Safely throw away RELISTOR pre-filled syringes and attached needle after use.
To avoid needle-stick injuries, do not recap used needles.
Avoid touching the trigger fingers of the RELISTOR pre-filled syringe to keep from activating the needle guard (safety device) too soon. The needle guard is activated by pressure from the plunger on the trigger fingers (See Figure A).

Gather the supplies you will need for your injection (See Figure A). These include:

1 RELISTOR pre-filled syringe with attached needle
1 alcohol swab
1 cotton ball or gauze
1 adhesive bandage
a puncture resistant container, such as an FDA-cleared sharps disposal container to dispose of used pre-filled syringes and needles. See Step 4: “Dispose of used pre-filled syringes and needles.”

Step 1: Choose and prepare the injection site

Choose an injection site on your stomach-area (abdomen), thighs, or upper arms. See the shaded areas in Figures B and C below. 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.
Figure B Abdomen or thigh – use these sites when injecting yourself or another person.
Figure C Upper arm – use this site only when injecting another person.

Clean the injection site with an alcohol swab and let it air dry. Do not touch this area again before giving the injection (See Figure D).

Step 2: Prepare the pre-filled syringe

Choose a flat, clean, well-lit work surface.
Wash your hands with soap and water before preparing for the injection.
Look at the pre-filled syringe of RELISTOR (See Figure E). Make sure that the dose prescribed by your healthcare provider matches the dose on the pre-filled 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 (See Figure E).

The liquid in the pre-filled syringe should be colorless to pale yellow, and should not have any particles in it. Do not use the pre-filled syringe if it looks discolored, cloudy, or has any particles.
Use one hand to firmly hold the barrel of the pre-filled syringe. Use your other hand to pull the needle cap straight off (See Figure F). Do not touch the needle or allow it to touch anything.

Step 3: Inject RELISTOR

Use one hand to pinch the skin around the injection site (See Figure G).

Use your other hand to hold the pre-filled syringe. Insert the full length of the needle into the skin at a 45-degree angle with a quick “dart-like” motion (See Figure H).

Let go of the skin and slowly push the plunger in with your thumb until the pre-filled syringe is empty (See Figure I). This will release the needle guard (safety device).

Continue 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. Remove your thumb from the plunger to allow the protective sleeve to cover the needle (See Figure J). There may be a little bleeding at the injection site.

Hold a cotton ball or gauze over the injection site (See Figure K). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.

Step 4: Dispose of used pre-filled syringes and needles

Do not reuse the pre-filled syringe and attached needle.
To avoid needle-stick injuries, do not recap used needles.
Put your used pre-filled syringes and attached needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
made of a heavy-duty plastic,
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
upright and stable during use,
leak-resistant, and
properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
If you have any questions, talk to your healthcare provider or pharmacist.