ymlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

• Check Pen label before each use to make sure you have the 15•30•45•60 mcg Pen.
• Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
• If you drop your Pen, go to New Pen Setup to confirm Pen works.
• If any part of your Pen appears broken or damaged, do not use.
• This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
• If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

• Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
• Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
• Do not share your Pen or needles with anyone.
• Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
• Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
• Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

• Pen that has never been used:
  -Refrigerate (36°F to 46°F, 2°C to 8°C).
  -Protect from light.
  -Do not freeze. Do not use a Pen that has been frozen.
• Pen in use:
  -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
• Pen should not be used after the expiration (EXP) date printed on the label.
• Do not store Pen with needle attached, or with Knob pulled out.
• If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
• White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
• Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

• The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
• If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
• If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

• Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
• To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

• The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
• Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
• To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

• If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
• If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

• Watch for a stream when you start to push the Knob.
• The liquid is clear and colorless, so it may be difficult to see.
• Pull out the Knob all the way - you will hear clicking.
• Firmly push in the Knob all the way- you will hear clicking.
• If there is no stream of liquid after 6 attempts, replace the needle and repeat setup.
• If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

• Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

• Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
• Pull out the Knob all the way - you will hear clicking (see Figure B).
• Be sure that number on the Dose Check matches your dose in Window.
  You must see line, arrow, and number on Dose Check (see Figure C).
• Firmly push in the Knob all the way - you will hear clicking.
• Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

• You may see one or two drops - this is normal.
• If you see more than 2 drops:
  -You may not have received your full dose.
  -Do not inject another dose.
  -Talk to your healthcare provider.
• To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

• Check Your Dose after pulling out the Knob (see Figure C).
• The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

• If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

Symlin

• Patient Information:
  Details with Side Effects

Symlin

• Patient Information:
  Details with Side Effects

Symlin

• Patient Information:
  Details with Side Effects

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

• Check Pen label before each use to make sure you have the 60•120 mcg Pen.
• Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
• If you drop your Pen, go to New Pen Setup to confirm Pen works.
• If any part of your Pen appears broken or damaged, do not use.
• This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
• If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

• Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
• Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
• Do not share your Pen or needles with anyone.
• Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
• Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
• Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

• Pen that has never been used:
  -Refrigerate (36°F to 46°F, 2°C to 8°C).
  -Protect from light.
  -Do not freeze. Do not use a Pen that has been frozen.
• Pen in use:
  -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
• Pen should not be used after the expiration (EXP) date printed on the label.
• Do not store Pen with needle attached, or with Knob pulled out.
• If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
• White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
• Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

• The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
• If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
• If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

• Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
• To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

• The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
• Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
• To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

• If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
• If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

• Watch for a stream when you start to push the Knob.
• The liquid is clear and colorless, so it may be difficult to see.
• Pull out the Knob all the way - you will hear clicking.
• Firmly push in the Knob all the way- you will hear clicking.
• If there is no stream of liquid after 3 attempts, replace the needle and repeat setup.
• If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

• Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

• Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
• Pull out the Knob all the way - you will hear clicking (see Figure B).
• Be sure that number on the Dose Check matches your dose in Window.

You must see line, arrow, and number on Dose Check (see Figure C).

• Firmly push in the Knob all the way - you will hear clicking.
• Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

• You may see one or two drops
  - this is normal.
• If you see more than 2 drops:
  -You may not have received your full dose.
  -Do not inject another dose.
  -Talk to your healthcare provider.
• To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

• Check Your Dose after pulling out the Knob (see Figure C).
• The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

• If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

Sy