SYMLIN SymlinPen 120 User manual

SYMLIN
®
(pramlintide acetate) injection for subcutaneous use 4
• Remove paper tab from outer needle cover.
• Push needle straight onto Pen.
• Screw needle on until tight.
• Remove outer needle cover and save for
needle removal.
• Remove inner needle cover and throw away.
Paper Tab
Needle
Inner Needle
Cover
Outer Needle
Cover
Important:
• Ask your healthcare provider about your dose of SYMLIN and how to inject SYMLIN the right way before you inject it for the first time.
• Use a new needle for each SYMLIN injection. Do not reuse or share your needles with other people. You may give other people a serious
infection, or get a serious infection from them.
• This SymlinPen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of this
SymlinPen.
• Check SYMLIN before you use it. SYMLIN should be clear and colorless. Do not use SYMLIN if the liquid looks cloudy or colored or has lumps
or particles in it.
• Your SymlinPen may look empty because SYMLIN is a clear and colorless liquid.
• Small bubbles will not hurt you or affect your dose of SYMLIN.
•Do not transfer SYMLIN from your SymlinPen into a syringe.
•Do not inject your dose of SYMLIN if you:
°have low blood sugar (hypoglycemia)
°do not plan to eat. Do not inject SYMLIN if you skip a meal. Wait until the next meal and take your usual dose of SYMLIN at that meal.
°plan to eat a meal with less than 250 calories or 30 grams of carbohydrate
°are sick and cannot eat your usual meal
°are having surgery or a medical test where you cannot eat
• If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and may not be able to eat the amount of food you
usually eat. If you take more SYMLIN than your prescribed dose, pay careful attention to the amount of insulin you use because you may be
at more risk for low blood sugar. Contact your healthcare provider for guidance.
Supplies you will need to give each injection of SYMLI :
• SymlinPen®120 Pen-Injector (Pen) (See Figure A)
• a new SymlinPen compatible needle (See Figure B). Pen needles are not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your
healthcare provider which needle gauge and length is best for you.
• alcohol swab
• 1 sharps container for throwing away used SymlinPens and needles. See “Disposing of used SymlinPens and needles” at the end of these
Instructions for Use.
SymlinPen® (SĬM-lĭnPen) 120
(pramlintide acetate)
Pen-Injector
Read the Medication Guide and these Instructions for Use before you start using SYMLIN and each time you get a refill. There may be new information.
Do not share your SymlinPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a
serious infection from them.
Pen Parts
Attach Pen eedle (needles not included)
Pen Cap
Covers Pen when not in use
Pen Label
EXP date on back
Dial
Turn to dial dose
Knob:
Pull out to load dose.
Spin to check dose.
Push to inject dose.
Dose Check
Look for line, arrow, and number
Cartridge
Clear colorless liquid
Window
Shows dialed dose
(Figure B)
(Figure A)

Preparing your SymlinPen:
• Wash your hands with soap and water.
• Check the SymlinPen label before each use to make sure you have
the right SymlinPen.
• Check the expiration date (EXP) on the SymlinPen label (See Figure
A). Do not use the SymlinPen past the expiration date printed on the
label.
• Check the liquid in your SymlinPen to make sure you have enough
SYMLIN left in your SymlinPen to load your correct dose.
°The lines on the cartridge show about how much SYMLIN is
left in your SymlinPen. When the top of the plunger is at the
thickest line on the cartridge, your SymlinPen is almost empty
(See Figure C).
Attaching a eedle:
Step 1:
• Pull the pen cap straight off the SymlinPen and wipe the rubber
seal with an alcohol swab.
Step 2:
• Get a new needle
• Peel off the paper tab and throw it away.
Step 3:
• Push the capped needle straight onto the end of the SymlinPen
and twist the needle clockwise until it is tight.
Figure D
Figure F
Figure E
(Figure C)

Step 4:
• Pull off the outer needle cover. Do not throw it away.
• Pull off the inner needle cover and throw it away.
ew Pen Setup - Priming your SymlinPen:
ote:
• Steps 5 through 7 are only required if you are using your SymlinPen
for the first time. Do not repeat Step 1 through 4 before each dose.
•If you have already primed your SymlinPen, go to Step 8 for
instructions about giving your scheduled dose.
Step 5:
• Turn the dial to select 60 mcg.
°You should see the number 60 in the window.
Step 6:
• Pull the knob straight out as far as it will go. You should hear a
“clicking” sound while you are pulling the knob out.
Step 7:
• old your SymlinPen with the needle pointing up. Push the
knob all the way in until it stops. You should hear a “clicking”
sound while you are pushing the knob in.
°A stream of liquid should be seen from the needle.
• If you do not see a
stream of liquid,
repeat Step 6 and
Step 7 (you may repeat
up to 3 times).
• If you still do not see a
stream of liquid after
3 attempts, change
the needle and repeat
Step 6 and Step 7.
If you still do not see
a stream of liquid,
call Information
Support.
Figure I
Figure G
Figure H
Figure J

Selecting your routine dose:
Step 8:
• Turn the dial to select the correct dose you need to inject.
Step 9:
• Pull the knob straight out as far as it will go. You should hear a
“clicking” sound while you are pulling the knob out.
Step 10:
• Turn the knob forward or backward until you see the correct
dose you need to inject.
• Check that you see the line to make sure you have loaded
your full dose. You should see a line, arrow, and the number
of your dose.
°If you do not see a line, arrow, and the number of your
dose, do not inject the dose. Point the needle away from
you, push the knob all the way in until it stops, then repeat
Step 8 to Step 10.
°Once the knob has been pulled out, the dial will not move
and you cannot reset your dose. If correct dose was not
selected, push in the knob to discard the dose and repeat
the instructions. If the knob is pushed in all the way, and
you cannot turn the dial, call Information Support.
Giving your SYMLI injection:
• Inject your SYMLIN exactly as your doctor has shown you.
• Change (rotate) injection sites for SYMLIN. Inject SYMLIN at a
site that is more than 2 inches away from your insulin injection.
Do not inject SYMLIN and insulin in the same site.
• To help reduce the chances of getting a reaction at the injection site,
let SYMLIN come to room temperature before you inject it.
Figure K
Figure L
Figure M
Figure N

Step 11:
• Choose your injection site.
• SYMLIN is injected under the skin (subcutaneously) of your
stomach area (abdomen) or upper leg (thigh).
• Wipe the skin with an alcohol swab, and let the injection site dry
before you inject your dose.
Step 12:
• Insert the needle into your skin.
Figure P
Figure O

Step 13:
• Put your thumb on the knob and push the knob all the way in
until it stops. You should hear the “clicking” as you push and
hold the knob in and slowly count to 10 to give your full dose.
Step 14:
• Pull the needle out of your skin.
• If you see blood after you take the needle out of your skin, press
the injection site lightly with a piece of gauze or an alcohol
swab. Do not rub the area.
°A drop or 2 of liquid on the needle tip is normal. It will not
affect your dose.
°If you see more than 2 drops, you may not have received
your full dose. Do not inject another dose. Talk to your
doctor for help.
Step 15:
• Carefully replace the outer needle cover by pushing straight
onto the end of the SymlinPen.
Step 16:
• Unscrew the capped needle counterclockwise with the outer
needle cover on it and throw it away.
•Do not store the SymlinPen with the needle attached or with the
knob pulled out to prevent air bubbles.
Step 17:
• Replace the pen cap.
SYMLIN
®
(pramlintide acetate) injection for subcutaneous use 5
Figure R
Figure S
Figure T
Figure U
Figure Q

After your injection:
• Put your used needles and SymlinPen 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:
æ made of a heavy-duty plastic,
æ can be closed with a tight-fitting, puncture-resistant lid,
without sharps being able to come out,
æ upright and stable during use,
æ leak-resistant, and
æ 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 SymlinPen. 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.
How should I store my SymlinPen?
Unused SymlinPens:
• Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C to 8°C),
until you are ready to use it.
•Do not freeze. Do not use SYMLIN if it has been frozen.
• Keep unopened SYMLIN out of the light.
Used SymlinPens:
• Store SymlinPens in the refrigerator or at room temperature
between 36°F to 86°F (2°C to 30°C) for up to 30 days.
• Throw away used SymlinPens after 30 days of use, even if a used
SymlinPen still has medicine in it.
•Do not use SymlinPens (opened or unopened) after the expiration
(EXP) date printed on the carton and the label.
General information about the safe and effective
use of SymlinPens.
• If you drop your SymlinPen, you should prime it before you use it
to make sure your SymlinPen works.
•Do not use your SymlinPen if any part looks broken or damaged.
•Keep SYMLIN and all medicines out of the reach of children.
• It is not known if SYMLIN is safe and effective in children.
If you are having problems using your SymlinPen, go to
www.SYMLIN.com or call Information Support at 1-800-236-9933.
These Instructions for Use have been approved by the U.S. Food and Drug
Administration.
SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group
of companies.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Revised: March 2015 US-9066 5/17