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Relistor

PATIENT INFORMATION

RELISTOR®
(rel - i – store)
(methylnaltrexone bromide) Subcutaneous Injection

Read this Patient Information that comes with RELISTOR before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is RELISTOR?

RELISTOR is a prescription medicine used to treat constipation that is caused by prescription pain medicines, called opioids, in patients receiving supportive care for their advanced illness, when other medicines for constipation, called laxatives, have not worked well enough.

It is not known if RELISTOR is safe and effective if used for longer than 4 months in people with advanced illness.

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

Who should not use RELISTOR?

Do not use 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 stomach-area (abdomen). Talk to your healthcare provider if you have any of these symptoms before using RELISTOR.

What should I tell my healthcare provider before using RELISTOR?

Before you start using RELISTOR, tell your healthcare provider if you:

  • have kidney problems
  • have or had cancer of the stomach or intestine
  • have or had a stomach ulcer
  • have had a blockage in your intestine
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if RELISTOR can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if RELISTOR passes into your breast milk.

Tell your healthcare provider about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Continue taking your other medicines for constipation unless your healthcare provider tells you to stop taking them.

How should I use RELISTOR?

  • RELISTOR is injected under the skin (subcutaneous injection) of the upper arm, abdomen, or thigh.
  • Inject RELISTOR exactly as your healthcare provider tells you.
  • RELISTOR is usually used every other day. Do not inject more than one dose of RELISTOR in a 24-hour period.
  • Stay close to a toilet after using RELISTOR.
  • Stop using RELISTOR if you stop taking your prescription opioid pain medicine.
  • If you inject more RELISTOR than prescribed, talk to your healthcare provider right away.

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

What are the possible side effects of RELISTOR?

RELISTOR can cause serious side effects, including:

  • Tear in your stomach or intestinal wall (perforation).
  • Stop using RELISTOR and call your healthcare provider right away if you develop swelling or pain in you stomach-area (abdomen) that is severe, gets worse, or that does not go away, nausea or vomiting that does not go away, or if you vomit blood or have black sticky stools.
  • 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.

The most common side effects of RELISTOR include:

  • stomach-area (abdomen) pain
  • gas
  • nausea
  • dizziness
  • diarrhea
  • sweating

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.

How should I store RELISTOR?

  • Store RELISTOR vials and pre-filled syringes at room temperature between 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.

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

General information about RELISTOR

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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.

This leaflet summarizes the most important information about RELISTOR. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about RELISTOR that is written for health professionals.

For more information, go to WWW.RELISTOR.COM.

What are the ingredients in RELISTOR?

Active ingredient: methylnaltrexone bromide

Inactive ingredients: sodium chloride, edetate calcium disodium USP, glycine hydrochloride.

During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Instructions for Use

RELISTOR®
(rel-i-store)
(methylnaltrexone bromide)

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 one 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 container to dispose of used pre-filled syringes and needles. See Step 4: “Dispose of used pre-filled syringes and needles.”

Figure A

Pre filled syringe parts - Illustration

Step 1: Choose and prepare the injection site

  • Choose an injection site on your 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.

Figure B Figure C

Injection site - Illustration

  • 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).

Figure D

Clean the injection site - Illustration

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).

Figure E

Prepare the pre-filled syringe - Illustration

  • The liquid in the pre-filled syringe should be clear and 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 (Figure F). Do not touch the needle or allow it to touch anything.

Figure F

Pull the needle cap straight off - Illustration

Step 3: Inject RELISTOR

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

Figure G

Pinch the skin - Illustration

  • 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).

Figure H

Insert needle - Illustration

  • 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).

Figure I

Push the plunger in - Illustration

  • 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.

Figure J

Allow the protective sleeve to cover the needle - Illustration

  • 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.

Figure K

Hold a cotton ball or gauze over the injection site - Illustration

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

  • Do not re-use 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 a 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 a 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.

How should I store RELISTOR?

  • Store pre-filled syringes at room temperature between 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.

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Instructions for Use

RELISTOR®
(rel-i-store)
(methylnaltrexone bromide)

Vial and Syringe with Retractable Needle in Tray

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 RELISTOR tray containing a syringe with a retractable needle. A retractable needle is one that is pulled back so that it is covered after use, to prevent needle-stick injury.

Important information:

  • 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, carefully recap the needle and 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?” at the end of this Instructions for Use.
  • Safely throw away RELISTOR vials after use.
  • Do not reuse syringes and needles. See Step 5: “Dispose of used syringes and needles” for information about how to safely throw away used needles and syringes.
  • To avoid needle-stick injuries, do not recap used needles.

Your tray should include (See Figure A):

  • 1 RELISTOR vial
  • 1 1 mL syringe with retractable needle (VanishPoint®)
  • 2 alcohol swabs

You will also need:

  • 1 cotton ball or gauze
  • 1 adhesive bandage
  • a container to dispose of your used syringes and needles. See Step 5: “Dispose of used syringes and needles.”

Vial and Syringe Parts

Figure A

Contents of tray - Illustration

Step 1: Choose and prepare the injection site

  • Choose an injection site on your abdomen, thighs, or upper arms. See the shaded areas in 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.

Figure B and Figure C

Injection site - Illustration

  • 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).

Figure D

Clean the injection site - Illustration

Step 2: Prepare the injection

  • Choose a flat, clean, well-lit work surface.
  • Wash your hands with soap and water before preparing for the injection.
  • Look at the vial of RELISTOR (See Figure E). The liquid in the vial should be clear and colorless to pale yellow, and should not have any particles in it. Do not use the vial if it looks discolored, cloudy, or has any particles.

Figure E

The liquid in the vial should be clear - Illustration

Step 3: Prepare the syringe

  • Remove the cap from the vial containing RELISTOR (See Figure F).

Figure F

Remove the cap - Illustration

  • Wipe the rubber stopper with an alcohol swab (See Figure G).

Figure G

Wipe the rubber stopper - Illustration

  • Firmly hold the barrel of the syringe with one hand. With your other hand, pull the needle cap straight off (See Figure H). Do not touch the needle or allow it to touch anything

Figure H

Pull the needle cap straight off - Illustration

  • Carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (See Figures I and J). For most people, 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.

Figure I and Figure J

Pull back on the plunger to the requied dose - Illustration

  • Use one hand to hold the vial steady. Use your other hand to insert the needle straight down into the rubber top of the RELISTOR vial (See Figure K). 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.

Figure K

Insert the needle straight down - Illustration

  • Gently push down on the plunger until you feel resistance, and most of the air has gone from the syringe into the vial (See Figure L ). Stop pushing down on the plunger when you feel resistance. If you continue to push down on the plunger when you feel resistance, the needle will pull back (retract) into the syringe barrel.

Figure L

Gently push down on the plunger - Illustration

  • With 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 (See Figure M) until the tip lines up with the mark that matches your prescribed dose. For most people, 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.

Figure M

Slowly pull back on the plunger - Illustration

  • You may see some fluid or bubbles inside the vial when the syringe is filled. This is normal.
  • With the needle still in the vial, gently tap the syringe to make any air bubbles rise to the top (See Figure N).

Figure N

Gently tap the syringe -  Illustration

  • Gently push the plunger up until all air bubbles are out of the syringe (See Figure O). A small air bubble may stay in the syringe. This is okay and it will not affect the dose of medicine in the syringe.

Figure O

Gently push the plunger up - Illustration

  • Make 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 (See Figure P).

Figure P

Slowly pull back the plunger - Illustration

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

  • Slowly withdraw the needle from the vial. Do not touch the needle or allow it to touch anything). Safely throw away the vial with any unused medicine.

Step 4: Inject RELISTOR

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

Figure Q

Pinch the skin - Illustration

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

Figure R

Insert the full length of the needle - Illustration

  • Let go of the skin and slowly push in on the plunger past the resistance point, until the syringe is empty and you hear a click (See Figure S).

Figure S

Slowly push in on the plunger - Illustration

  • The click sound means that the needle (T) has been pulled back (retracted) into the syringe barrel (See Figure U). You can now remove the syringe from your skin.

Figure T and Figure U

Retract needle - Illustration

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

Figure V

Hold a cotton ball or gauze over the injection site - Illustration

Step 5: Dispose of used syringes and needles

  • Do not re-use syringes or needles.
  • To avoid needle-stick injuries, do not recap used needles.
  • Put your used needles and syringes in a 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 a 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.

How should I store RELISTOR?

  • Store RELISTOR vials at room temperature between 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.

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

RELISTOR®
(rel-i-store)
(methylnaltrexone bromide) Subcutaneous Injection Vial

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 vial of RELISTOR.

Important information:

  • Use the syringes and needles prescribed by your healthcare provider.
  • 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, carefully recap the needle and 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 “How should I store RELISTOR?” at the end of this Instructions for Use.
  • Safely throw away RELISTOR vials after use.
  • Do not re-use syringes or needles. See Step 5 “Dispose of used syringes and needles” for information about how to safely throw away used needles and syringes.
  • To avoid needle-stick injuries, do not recap used needles.

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

  • 1 RELISTOR vial
  • 1 1 mL syringe with a 27-gauge, ½ inch needle for subcutaneous use
  • 2 alcohol swabs
  • 1 cotton ball or gauze
  • 1 adhesive bandage
  • a container to dispose of used syringes and needles. See Step 5: “Dispose of used syringes and needles.”

Vial and Syringe Parts

Figure A

Required supplies - Illustration

Step 1: Choose and prepare the injection site

  • Choose an injection site on your 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.

Figure B and Figure C

Injection sites - Illustration

  • 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).

Figure D

Clean the injection site - Illustration

Step 2: Prepare the injection

  • Choose a flat, clean, well-lit work surface.
  • Wash your hands with soap and water before preparing for the injection.
  • Look at the vial of RELISTOR (See Figure E). The liquid in the vial should be clear and colorless to pale yellow, and should not have any particles in it. Do not use the vial if it looks discolored, cloudy, or has any particles.

Figure E

Inspect the vial - Illustration

Step 3: Prepare the syringe

  • Remove the cap from the RELISTOR vial (See Figure F).

Figure F

Remove the cap - Illustration

Wipe the rubber stopper with an alcohol swab (See Figure G).

Figure G

Wipe the rubber stopper - Illustration

  • Firmly hold the barrel of the syringe with one hand. With your other hand, pull the needle cap straight off (See Figure H). Do not touch the needle or allow it to touch anything.

Figure H

Pull the needle cap straight off - Illustration

  • Carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (See Figures I and J). For most people, 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.

Figure I and Figure J

Draw plunger back to needed dose - Illustration

  • Use one hand to hold the vial steady. Use your other hand to insert the needle straight down into the rubber top of the vial (See Figure K). 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.

Figure K

Insert the needle straight down - Illustration

  • Gently push down the plunger until all of the air has gone from the syringe into the vial (See Figure L).

Figure L

Gently push down the plunger - Illustration

  • With 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 (See Figure M) until the tip lines up with the mark that matches your prescribed dose. For most people, 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.

Figure M

Slowly pull back on the plunger - Illustration

  • You may see some fluid or bubbles inside the vial when the syringe is filled. This is normal.
  • With the needle still in the vial, gently tap the side of the syringe to make any air bubbles rise to the top (See Figure N).

Figure N

gently tap the side of the syringe - Illustration

  • Slowly push the plunger up until all air bubbles are out of the syringe (See Figure O). A small air bubble may stay in the syringe. This is okay and it will not affect the dose of medicine in the syringe.

Figure O

Slowly push the plunger up - Illustration

  • Make 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 (See Figure P).

Figure P

Draw the right amount of liquid - Illustration

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

  • Slowly withdraw the needle from the vial. Do not touch the needle or allow it to touch anything. Safely throw away the vial with any unused medicine.

Step 4: Inject RELISTOR

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

Figure Q

Pinch the skin - Illustration

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

Figure R

Insert the full length of the needle - Illustration

Let go of the skin and slowly push in on the plunger until the syringe is empty (Figure S).

Figure S

Slowly push in on the plunger - Illustration

  • When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted. There may be a little bleeding at the injection site.
  • Hold a cotton ball or gauze over the injection site (Figure T). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.

Figure T

Hold a cotton ball or gauze over the injection site -  Illustration

Step 5: Dispose of used syringes and needles

  • Do not re-use a syringe or needle.
  • To avoid needle-stick injuries, do not recap a used needle.
  • Put your used needles and syringes in a 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 a 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.

How should I store RELISTOR?

  • Store RELISTOR vials at room temperature between 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.

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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