Consumer Information for: RELISTOR

VIALS

RELISTOR is a sterile, clear and colourless to pale yellow aqueous solution. Before use, inspect the vial and if there are any solid particles in the solution or it is discoloured, discard and do not use this vial. Use another vial.

Usual Adult dose:

The recommended dose of RELISTOR is 8 mg or 12 mg once every other day as directed by your healthcare professional, based on weight. See the table below to determine the correct injection volume for you.

Patient Weight Pounds	Patient Weight Kilograms	Injection Volume	Total Dose
73 to less than 84	33 to less than 38	0.3 mL	6 mg
84 to less than 136	38 to less than 62	0.4 mL	8 mg
136 to 251	62 to 114	0.6 mL	12 mg
252 to 277	115 to 126 kg	0.9 mL	18 mg

If your weight falls outside the ranges in this table, your healthcare professional will calculate the dosage for you.

If you have kidney problems, your healthcare professional will calculate the appropriate dose for you.

If no improvement is seen within a week, contact your healthcare professional.

Overdose

Missed Dose

Not Applicable

VIALS AND SYRINGE WITH RETRACTABLE NEEDLE IN TRAY

RELISTOR is a sterile, clear and colourless to pale yellow aqueous solution. Before use, inspect the vial and if there are any solid particles in the solution or it is discoloured, discard and do not use this vial. Use another vial.

Usual Adult dose:

The recommended dose of RELISTOR is 8 mg or 12 mg once every other day as directed by your healthcare professional, based on weight. See the table below to determine the correct injection volume for you.

Patient Weight Pounds	Patient Weight Kilograms	Injection Volume	Total Dose
73 to less than 84	33 to less than 38	0.3 mL	6 mg
84 to less than 136	38 to less than 62	0.4 mL	8 mg
136 to 251	62 to 114	0.6 mL	12 mg
252 to 277	115 to 126 kg	0.9 mL	18 mg

If your weight falls outside the ranges in this table, your healthcare professional will calculate the dosage for you.

If you have kidney problems, your healthcare professional will calculate the appropriate dose for you.

If no improvement is seen within a week, contact your healthcare professional.

Overdose

Missed Dose

Not Applicable

PRE-FILLED SYRINGES

RELISTOR is a sterile, clear and colourless to pale yellow aqueous solution. Before use, inspect the vial and if there are any solid particles in the solution or it is discoloured, discard and do not use this vial. Use another vial.

Usual Adult dose:

The recommended dose of RELISTOR is 8 mg or 12 mg once every other day as directed by your healthcare professional, based on weight. See the table below to determine the correct injection volume for you.

Patient Weight Pounds	Patient Weight Kilograms	Injection Volume	Total Dose
73 to less than 84	33 to less than 38	0.3 mL	6 mg
84 to less than 136	38 to less than 62	0.4 mL	8 mg
136 to 251	62 to 114	0.6 mL	12 mg
252 to 277	115 to 126 kg	0.9 mL	18 mg

If your weight falls outside the ranges in this table, your healthcare professional will calculate the dosage for you.

If you have kidney problems, your healthcare professional will calculate the appropriate dose for you.

If no improvement is seen within a week, contact your healthcare professional.

Overdose

Missed Dose

Not Applicable

The Patient Instructions for Use

VIALS
VIALS AND SYRINGE WITH RETRACTABLE NEEDLE IN TRAY
PRE-FILLED SYRINGES

VIALS

Patient Instructions for Methylnaltrexone Bromide Vial to be used with a Standard Syringe and Needle (Note: Standard syringe and needle are not supplied with the vials)

Introduction

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

The Patient Instructions for Use include the following steps:

Step 1: Preparing the injection
Step 2: Preparing the syringe
Step 3: Choosing and preparing an injection site
Step 4: Injecting 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:

• Methylnaltrexone bromide vial
• 1 mL syringe with a 27-gauge needle for subcutaneous use
• Two alcohol swabs
• Cotton ball or gauze
• Adhesive bandage

Important Notes:

• 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.
• Do not reuse 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 (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 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. Insert the needle straight down into the rubber top of the vial (Figure 5). 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 5

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


Figure 6

6. 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 7) 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 7

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


Figure 8

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


Figure 9

9. 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 10).


Figure 10

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.

10. 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 11 and 12 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 11. Abdomen or thigh – use these sites when injecting yourself or another person.



Figure 12. Upper arm – use this site only when injecting another person.

2. Clean the injection site with an alcohol swab and let it airdry. Do not touch this area again before giving the injection (Figure 13).


Figure 13

Step 4: Injecting methylnaltrexone bromide

1. Pinch the skin around the injection site as you were instructed (Figure 14).


Figure 14

2. Insert the full length of the needle into the skin at a 45- degree angle with a quick “dart-like” motion (Figure 15).


Figure 15

3. Let go of skin and slowly push down on the plunger until the syringe is empty (Figure 16).


Figure 16

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 17). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.


Figure 17

Step 5: Disposing of supplies

• Do not reuse 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.

If you have any questions, talk to your healthcare provider or pharmacist.

VIALS AND SYRINGE WITH RETRACTABLE NEEDLE IN TRAY

Patient Instructions for Use of Methylnaltrexone Bromide Vial and Syringe with Retractable Needle in Tray

Introduction
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.

The Patient Instructions for Use include the following steps:

Step 1: Preparing the injection
Step 2: Preparing the syringe
Step 3: Choosing and preparing an injection site
Step 4: Injecting 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 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:

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

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

Important Notes:

• Do not use a vial more than one time, even if there is medicine left in the vial.
• Do not reuse syringes and needles.
• To avoid needle-stick injuries, do not recap 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 (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 (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 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. If this happens, discard the product and start again with another vial and syringe.


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

8. 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 (Figure 9).


Figure 9

9. 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 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.

10. 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. 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

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

3. After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject RELISTOR.
4. When you hear a click sound that means the entire contents were injected, and the needle will automatically retract and be capped. The click sound means that the needle (Figure 17) has been retracted (pulled back) into the syringe barrel (Figure 18).



Figure 17




Figure 18

5. There may be a little bleeding at the injection site. Hold a cotton ball or gauze over the injection site (Figure 19). Do not rub the injection site. Apply an adhesive bandage to the injection site if needed.



Figure 19

Step 5: Disposing of supplies

• Do not reuse 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.

PRE-FILLED SYRINGES

Patient instructions for use of RELISTOR pre-filled syringe

Introduction

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

The patient instructions for use include 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 using pre-filled syringe
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:

• Methylnaltrexone bromide pre-filled syringe
• Two alcohol swabs
• Cotton ball or gauze
• Adhesive bandage

Important Notes:

Do not use RELISTOR pre-filled syringe more than one time, even if there is medicine left in the syringe.
Safely throw away RELISTOR pre-filled syringes after use (see Step 5).
To avoid needle-stick injuries, do not recap used needles.