RELISTOR® (methylnaltrexone bromide)
[rel - i - store]
(mcthylnaltrcxonc bromide) Injection

Read the Patient Information that comes with RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) ?

RELISTOR (methylnaltrexone bromide) 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.

Who should not take RELISTOR (methylnaltrexone bromide) ?

Do not take RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) .

What should I tell my healthcare provider before taking RELISTOR (methylnaltrexone bromide) ?

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 (methylnaltrexone bromide) can harm your unborn baby. If you become pregnant while using RELISTOR (methylnaltrexone bromide) , tell your healthcare provider right away.
• are breast-feeding or plan to breast-feed. It is not known if RELISTOR (methylnaltrexone bromide) passes into your breast milk.

Tell your healthcare provider about all medicines you take. Continue taking your other medicines for constipation unless your healthcare provider tells you to stop taking them.

How should I take RELISTOR (methylnaltrexone bromide) ?

• Take RELISTOR (methylnaltrexone bromide) exactly as your healthcare provider tells you.
• Take RELISTOR (methylnaltrexone bromide) by an injection under the skin (subcutaneous injection) of the upper arm, abdomen, or thigh.
• Do not take more than one dose in a 24-hour period.
• Most patients have a bowel movement within a few minutes to a few hours after taking a dose of RELISTOR (methylnaltrexone bromide) .
• If you stop taking your prescription pain medicine, check with your healthcare provider before continuing to take RELISTOR (methylnaltrexone bromide) .
• If you take more RELISTOR (methylnaltrexone bromide) than prescribed, talk to your healthcare provider right away.

See the detailed Patient Instructions for Use at the end of this Patient Information leaflet for information about how to prepare and inject RELISTOR (methylnaltrexone bromide) .

What are the possible side effects of RELISTOR (methylnaltrexone bromide) ?

• Common side effects of RELISTOR (methylnaltrexone bromide) include:
• abdominal (stomach) pain
• gas
• nausea
• dizziness
• diarrhea
• sweating
• If you get diarrhea that is severe or does not stop while taking RELISTOR (methylnaltrexone bromide) , stop taking RELISTOR (methylnaltrexone bromide) and call your healthcare provider.
• 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 (methylnaltrexone bromide) and call your healthcare provider.

These are not all of the possible side effects of RELISTOR (methylnaltrexone bromide) . Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 (methylnaltrexone bromide) ?

• Store RELISTOR (methylnaltrexone bromide) vials at 68 to 77°F (20 to 25°C).
• Do not freeze RELISTOR (methylnaltrexone bromide) .
• Keep RELISTOR (methylnaltrexone bromide) away from light until you are ready to use it.
• If RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) and all medicines, needles and syringes out of the reach of children.

General information about RELISTOR (methylnaltrexone bromide)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use RELISTOR (methylnaltrexone bromide) for a condition for which it was not prescribed. Do not give RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about RELISTOR (methylnaltrexone bromide) that is written for healthcare providers. For more information, go to WWW.RELISTOR (methylnaltrexone bromide) .COM or call 1-800-934-5556.

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.

Patient Instructions for Use of RELISTOR® (methylnaltrexone bromide) VIAL AND STANDARD SYRINGE AND NEEDLE

Introduction

The following instructions explain how to prepare and give an injection of RELISTOR (methylnaltrexone bromide) the right way, when using a vial of RELISTOR (methylnaltrexone bromide) , and a standard syringe.

The Patient Instructions for Use includes the following steps:

Step 1: Preparing the injection

Step 2: Preparing the syringe

Step 3: Choosing and preparing an injection site

Step 4: Injecting RELISTOR (methylnaltrexone bromide)

Step 5: Disposing of supplies

Before starting, read and make sure that 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 (methylnaltrexone bromide) vial
2. 1 mL syringe with a 27-gauge needle for subcutaneous use
3. 2 alcohol swabs
4. Cotton ball or gauze
5. Adhesive bandage

Important Notes:

• Use the syringes and needles prescribed by your healthcare provider.
• Do not use a RELISTOR (methylnaltrexone bromide) vial more than one time, even if there is medicine left in the vial.
• If RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) , see the section called "How should I store RELISTOR (methylnaltrexone bromide) ?" in the FDA-Approved Patient Labeling.
• Safely throw away RELISTOR (methylnaltrexone bromide) vials after use.
• Do not re-use syringes or needles.
• To avoid needle stick injuries, do not recap used needles.

Step 1: 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. Look at the vial of RELISTOR (methylnaltrexone bromide) (Figure 1). 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.

Figure 1

Step 2: Preparing the syringe

1. Remove the cap from the RELISTOR (methylnaltrexone bromide) vial (Figure 2).

Figure 2

2. Wipe the rubber stopper with an alcohol swab (Figure 3).

Figure 3

3. Firmly hold the barrel of the syringe and pull the needle cap straight off (Figure 4). Do not touch the needle or allow it to touch any surface.

Figure 4

4. Carefully pull back the plunger to the line that matches the dose prescribed by your healthcare provider (Figure 5). 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.

Figure 5

5. Insert the needle straight down into the rubber top of the vial (Figure 6). 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 6

6. Gently push down the plunger until all of the air is out of the syringe and has gone into the vial (Figure 7).

Figure 7

7. 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 (Figure 8) to the mark that matches your prescribed dose. 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.

Figure 8

8. With the needle still in the vial, gently tap the side of the syringe to make any air bubbles rise to the top (Figure 9).

Figure 9

9. Slowly push the plunger up until all air bubbles are out of the syringe (Figure 10).

Figure 10

10. 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 (Figure 11).

Figure 11

Check to be sure that you have the right dose of RELISTOR (methylnaltrexone bromide) 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.

Step 3: Choosing and preparing an injection site

1. Choose an injection site - abdomen, thighs, or upper arms. See shaded areas in Figures 12 and 13 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 12. Abdomen or thigh - use these sites when injecting yourself or another person.

Figure 13. Upper arm - use this site only when injecting another person.

Figure 12 Figure 13

2. Clean the injection site with an alcohol swab and let it air dry. Do not touch this area again before giving the injection (Figure 14).

Figure 14

Step 4: Injecting RELISTOR (methylnaltrexone bromide)

1. Pinch the skin around the injection site as you were instructed (Figure 15).

Figure 15

2. Insert the full length of the needle into the skin at a 45-degree angle with a quick "dart-like" motion (Figure 16).

Figure 16

3. Let go of skin and slowly push down on the plunger until the syringe is empty (Figure 17).

Figure 17

4. 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.

5. Hold a cotton ball or gauze over the injection site (Figure 18). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.

Figure 18

Step 5: Disposing of supplies

• Do not re-use a syringe or needle.
• Do not recap a used needle.
• Place used needle, 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 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.

Patient Instructions for Use of RELISTOR® (methylnaltrexone bromide) VIAL AND SYRINGE WITH RETRACTABLE NEEDLE IN TRAY

Introduction:

The following instructions explain how to prepare and give an injection of RELISTOR (methylnaltrexone bromide) the right way, when using a RELISTOR (methylnaltrexone bromide) 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.

The Patient Instructions for Use includes the following steps:

Step 1: Preparing the injection

Step 2: Preparing the syringe

Step 3: Choosing and preparing an injection site

Step 4: Injecting RELISTOR (methylnaltrexone bromide)

Step 5: Disposing of supplies

Before starting, read and make sure that you understand the Patient Instructions for Use. Familiarize yourself with the RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) vial
2. 1 mL syringe with retractable needle (VanishPoint®)
3. 2 alcohol swabs
4. Prescribing Information - information about RELISTOR (methylnaltrexone bromide) that is written for healthcare professionals
5. Patient Instructions for Use of RELISTOR (methylnaltrexone bromide) - instructions about RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) vial more than one time, even if there is medicine left in the vial.
• If RELISTOR (methylnaltrexone bromide) 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 (methylnaltrexone bromide) , see the section called "How should I store RELISTOR (methylnaltrexone bromide) ?" in the FDA-Approved Patient Labeling.
• Safely throw away RELISTOR (methylnaltrexone bromide) vials after use. 23
• Do not reuse syringes and needles.
• To avoid needle stick injuries, do not recap used needles.

Step 1: 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. Look at the vial of RELISTOR (methylnaltrexone bromide) (Figure 1). 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.

Figure 1

Step 2: Preparing the syringe

1. Remove the cap from the vial containing RELISTOR (methylnaltrexone bromide) (Figure 2).

Figure 2

2. Wipe the rubber stopper with an alcohol swab (Figure 3).

Figure 3

3. Firmly hold the barrel of the syringe and remove the needle cap straight off (Figure 4). Do not touch the needle or allow it to touch any surface.

Figure 4

4. Carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (Figure 5). 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.

Figure 5

5. Insert the needle straight down into the rubber top of the RELISTOR (methylnaltrexone bromide) vial (Figure 6). 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 6

6. Gently push down the plunger until you feel resistance, and most of the air has gone out of the syringe and into the vial (Figure 7). Do not push past the resistance point. Doing this will make the needle retract (pull back) into the syringe barrel.

Figure 7

7. 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 (Figure 8) 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).

Figure 8

You may see some fluid or bubbles inside the vial when the syringe is filled. This is normal.

8. With the needle still in the vial, gently tap the syringe to make any air bubbles rise to the top (Figure 9).

Figure 9

9. Slowly push the plunger up until all air bubbles are out of the syringe (Figure 10).

Figure 10

10. 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 (Figure 11).

Figure 11

Check to be sure that you have the right dose of RELISTOR (methylnaltrexone bromide) 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 the needle to touch any surface). Safely throw away the unused medicine in the vial. See Step 5.

Step 3: Choosing and preparing an injection site

1. Choose an injection site - abdomen, thighs, or upper arms. See shaded areas in Figures 12 and 13 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 12. Abdomen or thigh - use these sites when injecting yourself or another person.

Figure 13. Upper arm - use this site only when injecting another person.

Figure 12 &Figure 13

2. Clean the injection site with an alcohol swab and let it air dry. Do not touch this area again before giving the injection (Figure 14).

Figure 14

Step 4: Injecting RELISTOR (methylnaltrexone bromide)

1. Pinch the skin around the injection site as you were instructed (Figure 15).

Figure 15

2. Insert the full length of the needle into the skin at 45-degree angle with a "quick dart-like" motion (Figure 16).

Figure 16

Step 5: Disposing of supplies

3. Let 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 (Figure 17).

Figure 17

4. The click sound means that the needle (Figure 18) has been retracted (pulled back) into the syringe barrel (Figure 19).

Figure 18 & Figure 19

5. Hold a cotton ball or gauze over the injection site (Figure 20). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.

Figure 20

Step 5: Disposing of supplies

• Do not re-use a syringe or needle. Do not recap a used needle.
• 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.
• If you have any questions, talk to your healthcare provider or pharmacist.

Last reviewed on RxList: 8/13/2010
This monograph has been modified to include the generic and brand name in many instances.