TRESIBA
®
(insulin degludec injection)
10
Patient Information
TRESIBA
®
(tre-SI-bah)
(insulin degludec injection)
Do not share your TRESIBA
®
FlexTouch
®
insulin delivery device with other
people, even if the needle has changed. Do not share needles or syringes with
another person. You may give other people a serious infection, or get a serious
infection from them.
What is TRESIBA
®
?
• TRESIBA
®
is a man-made insulin that is used to control high blood sugar in adults and
children who are 1 year of age and older with diabetes mellitus.
• TRESIBA
®
is not for people with diabetic ketoacidosis (increased ketones in the blood or
urine).
• It is not known if TRESIBA
®
is safe and effective in children under 1 year of age.
• TRESIBA
®
is available in 2 concentrations (U-100 and U-200):
o
U-100 concentration is available in pen and vial
o
The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in
increments of 1 unit.
o
The 100 units/mL vial should be used with a U-100 insulin syringe only.
o
U-200 concentration is only available in pen
o
The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in
increments of 2 units.
Who should not take TRESIBA
®
?
Do not take TRESIBA
®
if you:
• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to TRESIBA
®
or any of the ingredients in TRESIBA
®
.
Before taking TRESIBA
®
, tell your healthcare provider about all your medical
conditions including, if you are:
• pregnant, planning to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking TRESIBA
®
, talk to your healthcare provider about low
blood sugar and how to manage it.
How should I take TRESIBA
®
?
•
Read the Instructions for Use
that come with your TRESIBA
®
.
• Take TRESIBA
®
exactly as your healthcare provider tells you to.
•
Do not do any conversion of your dose. The dose counter always shows the
selected dose in units.
Both the 100 units/mL and 200 units/mL TRESIBA
®
FlexTouch
®
pens are made to deliver your insulin dose in units.
• Know the type and strength of insulin you take.
Do not
change the type of insulin you take
unless your healthcare provider tells you to. The amount of insulin and the best time for you
to take your insulin may need to change if you take different types of insulin.
• For children who need less than 5 units of TRESIBA
®
each day, use a TRESIBA
®
U-100 vial.
• Adults: If you miss or are delayed in taking your dose of TRESIBA
®
:
o
Take your dose as soon as you remember then continue with your regular dosing
schedule.
o
Make sure there are at least
8
hours between your doses.
• If children miss a dose of TRESIBA
®
:
o
Call the healthcare provider for information and instructions about checking blood sugar
levels more often until the next scheduled dose of TRESIBA
®
.
•
Check your blood sugar levels.
Ask your healthcare provider what your blood sugars
should be and when you should check your blood sugar levels.
•
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.
•
Never
inject TRESIBA
®
into a vein or muscle.
•
Never
use a syringe to remove TRESIBA
®
from the FlexTouch
®
pen.
What should I avoid while taking TRESIBA
®
?
While taking TRESIBA
®
do not:
• Drive or operate heavy machinery, until you know how TRESIBA
®
affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of TRESIBA
®
?
TRESIBA
®
may cause serious side effects that can lead to death, including:
•
Low blood sugar (hypoglycemia).
Signs and symptoms that may indicate low blood
sugar include:
o
dizziness or light-headedness
o
blurred vision
o
anxiety, irritability, or mood changes
o
sweating
o
slurred speech
o
hunger
o
confusion
o
shakiness
o
headache
o
fast heartbeat
•
Low potassium in your blood (hypokalemia).
•
Heart failure.
Taking certain diabetes pills called thiazolidinediones or “TZDs” with
TRESIBA
®
may cause heart failure in some people. This can happen even if you have never
had heart failure or heart problems before. If you already have heart failure, it may get worse
while you take TZDs with TRESIBA
®
. Your healthcare provider should monitor you closely
while you are taking TZDs with TRESIBA
®
. Tell your healthcare provider if you have any new
or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your
ankles or feet and sudden weight gain. Treatment with TZDs and TRESIBA
®
may need to be
adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Your insulin dose may need to change because of:
• change in level of physical activity or exercise • increased stress
• change in diet
• weight gain or loss • illness
Common side effects of TRESIBA
®
may include:
• serious allergic reactions (whole body reactions), reactions at the injection site, skin
thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands
and feet, and weight gain.
Get emergency medical help if you have:
• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat,
sweating, extreme drowsiness, dizziness, confusion.
These are not all the possible side effects of TRESIBA
®
. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TRESIBA
®
.
Medicines are sometimes prescribed for purposes other than those listed in a Patient
Information leaflet. You can ask your pharmacist or healthcare provider for information about
TRESIBA
®
that is written for health professionals. Do not use TRESIBA
®
for a condition for
which it was not prescribed. Do not give TRESIBA
®
to other people, even if they have the same
symptoms that you have. It may harm them.
What are the ingredients in TRESIBA
®
?
Active Ingredient:
insulin degludec
Inactive Ingredients:
glycerol, metacresol, phenol, water for injection, and zinc. Hydrochloric
acid or sodium hydroxide may be added.
Manufactured by:
Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 11/2018
Novo Nordisk
®
, TRESIBA
®
, and FlexTouch
®
are registered trademarks of
Novo Nordisk A/S.
© 2015-2018 Novo Nordisk US18TSM00504 December 2018
