15
TRESIBA
®
(insulin degludec injection) 10 mL vial
Instructions for Use
TRESIBA
®
(tre–SI-bah)
(insulin degludec injection)
10 mL vial (100 units/mL, U-100)
Read this Instructions for Use before you start taking TRESIBA
®
and each time you get a refill. 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.
The vial is not recommended for use by the blind or visually
impaired without the assistance of a person trained in the proper
use of the product and insulin syringe.
Do not reuse or share syringes or needles with other
people. You may give other people a serious infection
or get a serious infection from them.
Supplies you will need to give your TRESIBA
®
injection:
• a 10 mL TRESIBA
®
vial
• a U-100 insulin syringe and
needle
• 2 alcohol swabs
• 1 sharps container for
throwing away used syringes
and needles. See “Disposing
of your used needles and
syringes” at the end of these
instructions.
Preparing your TRESIBA
®
dose:
•
Do not
roll or shake the TRESIBA
®
vial. Shaking the
TRESIBA
®
vial right before the dose is drawn into the syringe
may cause bubbles or foam. This can cause you to draw up
the wrong dose of insulin.
• The tamper-resistant cap should not be loose or damaged
before the first use.
Do not
use if the tamper-resistant cap is
loose or damaged before using TRESIBA
®
for the first time.
• Wash your hands with soap and water.
• Before you start to prepare your injection, check the
TRESIBA
®
label to make sure that you are taking the
right type of insulin. This is especially important if
you use more than 1 type of insulin.
• Check that the TRESIBA
®
vial is
not cracked or damaged.
Do not
use if the TRESIBA
®
vial is cracked or damaged.
• TRESIBA
®
should look clear
and colorless.
Do not
use
TRESIBA
®
if it is thick, cloudy,
or is colored.
•
Do not
use TRESIBA
®
past the
expiration date printed on the
label or 56 days after you start using the TRESIBA
®
vial.
Step 1:
Pull off the tamper-
resistant cap (See Figure A).
Step 2
: Wipe the rubber
stopper with an alcohol swab
(See Figure B).
(Figure A Figure B)
Step 3:
Hold the syringe with
the needle pointing up. Pull
down on the plunger until the
tip of the plunger reaches the
line for the number of units
for your prescribed dose
(See Figure C).
(Figure C)
Tamper
resistant cap
(rubber
stopper
under cap)
Vial
Step 4:
Push the needle
through the rubber stopper
of the TRESIBA
®
vial
(See Figure D).
(Figure D)
Step 5:
Push the plunger
all the way in. This puts
air into the TRESIBA
®
vial
(See Figure E).
(Figure E)
Step 6:
Turn the TRESIBA
®
vial and syringe upside
down and slowly pull the
plunger down until the tip
of the plunger is a few units
past the line for your dose
(See Figure F).
(Figure F)
If there are air bubbles, tap the
syringe gently a few times to
let any air bubbles rise to the
top (See Figure G).
(Figure G)
Step 7:
Slowly push the
plunger up until the tip of the
plunger reaches the line for
your prescribed TRESIBA
®
dose (See Figure H).
(Figure H)
Step 8:
Check the syringe to make sure you have the right dose
of TRESIBA
®
.
Step 9:
Pull the syringe out
of the rubber stopper on the
TRESIBA
®
vial (See Figure I).
(Figure I)
Giving your TRESIBA
®
injection:
•Inject your TRESIBA
®
exactly as your healthcare provider has
shown you. Your healthcare provider should tell you if you
need to pinch the skin before injecting.
• TRESIBA
®
can be injected under the skin (subcutaneously)
of your upper legs (thighs), upper arms, or stomach area
(abdomen). Do not inject TRESIBA
®
into your muscle.
• Change (rotate) your injection sites within the area you choose
for each injection.
Do not
use the same injection site for each
injection.
•
Do not
dilute or mix TRESIBA
®
with any other type of insulin
or solutions.
Step 10:
Choose your
injection site and wipe the
skin with an alcohol swab
(See Figure J).
Let the injection site dry
before you inject your dose.
(Figure J)
Step 11:
Insert the needle
into your skin. Push down on
the plunger to inject your dose
(See Figure K).
Make sure you have injected
all the insulin in the syringe.
(Figure K)
Step 12:
Pull the needle
out of your skin. After your
injection, you may see a drop
of TRESIBA
®
at the needle tip.
This is normal and does
not affect the dose you just
received (See Figure L).
• 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.
(Figure L)
After your injection:
•
Do not
recap the needle. Recapping the needle can lead to
needle stick injury.
Disposing of your used needles and syringes:
Put your used insulin needles and syringes in a 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 a FDA-cleared sharps disposal container, you
may use a household container that is:
o
made of a heavy-duty plastic
o
can be closed with a tight-fitting, puncture-resistant lid,
without sharps being able to come out
o
upright and stable during use
o
leak-resistant
o
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. Do not reuse or share needles or syringes
with another person. 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.
