BASAGLAR KwikPen User manual

Instructions for Use
BASAGLAR
®
KwikPen
®
insulin glargine injection (100 units/mL, 3mL pen)
Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLAR®
KwikPen®. 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.
Do not share your BASAGLARKwikPen with other people, even if the needle has been changed. You
may give other people a serious infection or get aserious infection from them.
BASAGLAR KwikPen (“Pen”) is a disposable prefilled pen containing 300 units (3mL) of BASAGLAR. One pen
contains multiple doses of medicine.
•Your healthcare provider will tell you how many units to give as your dose and how to inject your
prescribed dose of medicine.
•You can give a dose of 1to 80 units in asingle injection.
•If your prescribed dose is more than 80 units, you will need to give yourself more than 1injection.
•The plunger only moves a little with each injection, and you may not notice that it moves. When the plunger
reaches the end of the cartridge, you have used all 300 units in the Pen.
People who are blind or have vision problems should not use the Pen without help from a person trained to use
the Pen. KwikPen Parts
Pen Cap Cartridge Holder Label Dose Indicator
Cap Clip Rubber Seal Plunger Pen Body Dose Dose
Window
Knob
Pen Needle Parts
(Needles Not Included)
Paper Tab
Dose Knob
with
green ring
Outer Needle
Shield Inner Needle Shield Needle
•Pen color: Light grey
How
to
recognize
your
BASAGLAR
KwikPen:

•Dose Knob: Light grey with green ring on the end
•Labels: Light grey with green color bars
•BASAGLAR KwikPen
•KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
•Alcohol swab
•Wash your hands with soap and water.
•Check the Pen to make sure you are taking the right type of insulin. This is especially important if you use
more than 1type of insulin.
•Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first
start using the Pen.
•Always use a new needle for each injection to help prevent infections and blocked needles. 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.
Step 2:
•Check the liquid in the Pen.
BASAGLAR should look clear and colorless. Do not
use if it is cloudy, colored, or has particles or clumps
in it.
Supplies
needed
to
give
your
injection:
Preparing
your
Pen
Step
1:
•Pull the Pen Cap straight off.
-Do not remove the Pen Label.
•Wipe the Rubber Seal with an alcohol swab.
Step
3:
•Select a new Needle.
•Pull off the Paper Tab from the Outer Needle
Shield.
Step
4:
•Push the capped Needle straight onto the Pen
and twist the Needle on until it is tight.
Step
5:
•Pull off the Outer Needle Shield. Do not throw it
away.
•Pull off the Inner Needle Shield and throw it
away.

Priming your Pen
Prime before each injection.
•Priming means removing the air from the Needle and Cartridge that may collect during normal use. It is
important to prime your Pen before each injection so that it will work correctly.
•If you do not prime before each injection, you may get too much or too little insulin.
Step 8:
•Continue holding your Pen with Needle pointing
up. Push the Dose Knob in until it stops, and “0”
is seen in the Dose Window. Hold the Dose Knob
in and count to 5 slowly.
You should see insulin at the tip of the Needle.
-If you do not see insulin, repeat the priming
steps, but not more than 4 times.
-If you still do not see insulin, change the
Needle and repeat the priming steps.
Small air bubbles are normal and will not affect your
dose.
Step
6:
•To prime your Pen, turn the Dose Knob to select
2 units.
Step
7:
•Hold your Pen with the Needle pointing up. Tap
the Cartridge Holder gently to collect air bubbles
at the top.

•If your dose is more than 80 units, you will need to give more than 1injection.
-Talk to your healthcare provider about how to giveyour dose.
-Use a new Needle for each injection and repeat the priming step.
Step 9:
•Turn the Dose Knob to select the number of units
you need to inject. The Dose Indicator should line
up with your dose.
-The Pen dials 1unit at atime.
-The Dose Knob clicks as you turn it.
-Do not dial your dose by counting the clicks
because you may dial the wrong dose.
-The dose can be corrected by turning the
Dose Knob in either direction until the correct
dose lines up with the Dose Indicator.
-The even numbers are printed on the dial.
-The odd numbers, after the number 1, are
shown as full lines.
•Always check the number in the Dose
Window to make sure you have dialed the
correct dose.
(Example: 12 units shown
in the Dose Window)
(Example: 25 units shown
in the Dose Window)
•The Pen will not let you dial more than the number of units left in the Pen.
•If you need to inject more than the number of units left in the Pen, you may either:
-inject the amount leftin your Pen and then use anew Pen to give the rest of your dose, or
-get anew Pen and inject the full dose.
•It is normal to see asmall amount of insulin left in the Pen that you can not inject.
Selecting
your
dose

•Inject your insulin as your healthcare provider has shown you.
•Change (rotate) your injection site for each injection.
•Do not try to change your dose while injecting.
Step 11:
•Insert the Needle into your skin.
•Push the Dose Knob all the way in.
•Continue to hold the Dose Knob in
and slowly count to 5 before
removing the needle.
Note: Do not try to inject your insulin by turning the
Dose Knob. Youwill not receive your insulin by
turning the Dose Knob.
Giving
your
injection
Step
10:
Choose your injection site.
•BASAGLAR is injected under the skin
(subcutaneously) of your stomach area, buttocks,
upper legs or upper arms.
•Wipe the skin with an alcohol swab, and let the
injection site dry before you inject your dose.

Step 12:
•Pull the Needle out of your skin.
-A drop of insulin at the Needle tip is normal. It
will not affect your dose.
•Check the number in the Dose Window
-If you see “0” in the Dose Window, you have
received the full amount you dialed.
-If you do not see “0” in the Dose Window you
did not receive your full dose. Do not redial.
Insert the needle into your skin and finish
your injection.
-If you still do not think you received the full
amount you dialed for your injection, do not
start over or repeat that injection. Monitor
your blood glucose and call your healthcare
provider for further instructions.
-If you normally need to give 2 injections for
your full dose, be sure to give your second
injection.
The plunger only moves a little with each injection,
and you may not notice that it moves.
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.
After
your
injection
Disposing
of
Pens
and
Needles
Step
13:
•Carefully replace the Outer Needle Shield.
Step
14:
•Unscrew the capped Needle and throw it away
(see Disposing of Pens and Needles section
below).
•Do not store the Pen with the Needle attached to
prevent leaking, blocking the Needle, and air
from entering the Pen.
Step
15:
•Replace the Pen Cap by lining up the Cap Clip
with the Dose Indicator and pushing straight on.

•Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away
(dispose of) loose needles 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 aheavy-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.
•The used Pen may be discarded in your household trash after you have removed the needle.
Storing your BASAGLARKwikPen
Unused Pens
•Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
•Do not freeze BASAGLAR. Do not use if it has been frozen.
•Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the
refrigerator.
In-use Pen
•Store the Pen you are currently using at room temperature [up to 86°F (30°C)] and away from heat and
light.
•Throw away the Pen you are using after 28 days, even if it still has insulin left in it.
General information about the safe and effective use of your Pen
•Keep your Pen and needles out of the sight and reach of children.
•Always use a new needle for each injection.
•Do not share your Pen or needles with other people. You may give other people aserious infection
or get a serious infection from them.
•Do not use your Pen if any part looks broken or damaged.
•Always carry an extra Pen in case yours is lost or damaged.
•If you can not remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.
•If the Dose Knob is hard to push:
-Pushing the Dose Knob more slowly will make it easier to inject.
-Your Needle may be blocked. Put on a new Needle and prime the Pen.
-You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.
If you have any questions or problems with your BASAGLAR KwikPen, contact Lilly at 1-800-LillyRx (1-800-
545-5979) or call your healthcare provider for help. For more information on BASAGLAR KwikPen and insulin,
go to www.basaglar.com.
Troubleshooting

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This Instructions for Use have been approved by the U.S. Food and Drug Administration.
BASAGLAR
®
and BASAGLAR
®
KwikPen
®
are trademarks of Eli Lilly and Company.
Instructions for Use revised: September 2018
Marketed by:
Lilly USA, LLC
Indianapolis, IN 46285, USA
and
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877, USA
Copyright ©2015, 2018,Eli Lilly and Company. All rights reserved.
BI (logo) Lilly (red script)
BASKP-0005-IFU-20180905
BASAGLARKwikPen meets the current dose accuracy and functional requirements of ISO 11608-1:2014.