Novo Nordisk Victoza Pen User manual

Victoza® is a registered trademark of Novo Nordisk A/S.
Victoza® is covered by US Patent Nos 6,268,343, 6,458,924 and 7,235,627 and other patents pending.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights reserved. USA17VIM03811 December 2017
Please see Important Safety Information, including Boxed Warning, and Prescribing Information and Medication Guide, enclosed or at www.Victoza.com.
Important Information
•Do not share your Victoza®pen 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
•Always use a new needle for each injection
•Keep your Victoza®pen and all medicines out of the reach of children
•If you drop your Victoza®pen, repeat “First Time Use for Each New Pen”
•Be careful not to bend or damage the needle
•Do not use the cartridge scale to measure how much Victoza®to inject
•Be careful when handling used needles to avoid needle stick injuries
•You can use your Victoza®pen for up to 30 days after you use it for
the first time
Getting Started With
Your Victoza ®Pen
How Should I Store Victoza ®?
Before use:
•Store your new, unused Victoza®pen in the refrigerator at 36°F to 46°F
(2°C to 8°C)
•If Victoza®is stored outside of refrigeration (by mistake) prior to first use,
it should be used or thrown away within 30 days
•Do not freeze Victoza®or use Victoza®if it has been frozen. Do not store
Victoza®near the refrigerator cooling element
Introduction
First read the Medication Guide that comes with your Victoza®pen,
and then read these Patient Instructions for Use for information about
how to use your Victoza®pen the right way.
These instructions do not take the place of talking with your health care
provider about your medical condition or your treatment.
Your Victoza®pen contains 3 mL (18 mg) of Victoza®and will deliver doses
of 0.6 mg, 1.2 mg, or 1.8 mg. The number of doses that you can take with
a Victoza®pen depends on the dose of medicine that is prescribed for you.
Your health care provider will tell you how much Victoza®to take.
Victoza®pen should be used with Novo Nordisk disposable needles.
Talk to your health care provider or pharmacist for more information
about needles for your Victoza®pen.a
aNeedles are sold separately and may require a prescription in some states.
Caring For Your Victoza ®Pen
•After removing the needle, put the pen cap on your Victoza®pen and
store your Victoza®pen without the needle attached
•Do not try to refill your Victoza®pen—it is prefilled and is disposable
•Do not try to repair your pen or pull it apart
•Keep your Victoza®pen away from dust, dirt, and liquids
•If cleaning is needed, wipe the outside of the pen with a clean, damp cloth
If you are having problems using your Victoza®pen,
call toll-free 1-877-484-2869 or visit victoza.com.
Pen in use:
•Store your Victoza®pen for 30 days at 59°F to 86°F (15°C to 30°C), or in a
refrigerator at 36°F to 46°F (2°C to 8°C)
•When carrying the pen away from home, store the pen at a temperature
between 59°F to 86°F (15°C to 30°C)
•If Victoza®has been exposed to temperatures above 86°F (30°C), it should
be thrown away
•Protect your Victoza®pen from heat and sunlight
•Keep the pen cap on when your Victoza®pen is not in use
•Use a Victoza®pen for only 30 days. Throw away a used Victoza®pen after
30 days, even if some medicine is left in the pen
•Do not use Victoza®after the expiration date printed on the carton
Selected Important Safety Information
What is the most important information I should know
about Victoza®?
Victoza®may cause serious side effects, including:
•Possible thyroid tumors, including cancer. Tell your health care provider
if you get a lump or swelling in your neck, hoarseness, trouble swallowing,
or shortness of breath. These may be symptoms of thyroid cancer. In studies
with rats and mice, Victoza®and medicines that work like Victoza®caused
thyroid tumors, including thyroid cancer. It is not known if Victoza®will
cause thyroid tumors or a type of thyroid cancer called medullary thyroid
carcinoma (MTC) in people.
Who should not use Victoza®?
Do not use Victoza®if:
•you or any of your family have ever had MTC or if you have an endocrine
system condition called Multiple Endocrine Neoplasia syndrome type 2
(MEN 2).
•you are allergic to liraglutide or any of the ingredients in Victoza®.
Indication and Usage
What is Victoza®?
Victoza®(liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription
medicine for adults with type 2 diabetes that:
•along with diet and exercise may improve blood sugar (glucose).
•along with your current treatment for your cardiovascular disease may reduce
the risk of major cardiovascular events such as heart attack, stroke, or death.
Victoza®is not a substitute for insulin and is not for use in people with type 1
diabetes or people with diabetic ketoacidosis.
It is not known if Victoza®can be used with mealtime insulin.
It is not known if Victoza®is safe and effective for use in children.
Important Safety Information (cont’d)
What should I tell my health care provider before
using Victoza®?
Before using Victoza®, tell your health care provider if you:
•have or have had problems with your pancreas, kidneys, or liver.
• have any other medical conditions or severe problems with your stomach, such as
slowed emptying of your stomach (gastroparesis) or problems with digesting food.
•are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, herbal supplements, and
other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
•Do not mix insulin and Victoza®together in the same injection.
•You may give an injection of Victoza®and insulin in the same body area
(such as your stomach area), but not right next to each other.
•Do not share your Victoza®pen 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.
What are the possible side effects of Victoza®?
Victoza®may cause serious side effects, including:
•inflammation of your pancreas (pancreatitis). Stop using Victoza®
and call your health care provider right away if you have severe pain in
your stomach area (abdomen) that will not go away, with or without
vomiting. You may feel the pain from your abdomen to your back.
•low blood sugar (hypoglycemia). Your risk for getting low blood sugar
may be higher if you use Victoza®with another medicine that can cause
low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms
of low blood sugar may include: dizziness or lightheadedness, blurred
vision, anxiety, irritability or mood changes, sweating, slurred speech,
hunger, confusion or drowsiness, shakiness, weakness, headache, fast
heartbeat, and feeling jittery.
•kidney problems (kidney failure). In people who have kidney
problems, diarrhea, nausea, and vomiting may cause a loss of fluids
(dehydration), which may cause kidney problems to get worse.
•serious allergic reactions. Stop using Victoza®and get medical help right
away if you have any symptoms of a serious allergic reaction, including swelling
of your face, lips, tongue or throat, problems breathing or swallowing, severe
rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
•gallbladder problems. Gallbladder problems have happened in some
people who take Victoza. Tell your healthcare provider right away if you
get symptoms of gallbladder problems which may include pain in the
right or middle upper stomach area, fever, nausea and vomiting, or your
skin or the white part of your eyes turns yellow.
The most common side effects of Victoza®may include nausea,
diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Directions For Use
Victoza®Pen Needle (example)
Flow check
symbol
Dose
button
Pointer
Dose
display
Cartridge
scale
Pen cap
Rubber
stopper
Cartridge tip
Cartridge Dose selector
Outer
needle cap
Inner
needle cap Needle
Protective
tab
Take your new Victoza®
pen out of the refrigerator.
Wash hands with soap
and water before use.
Check pen label before
each use to make sure it
is your Victoza®pen.
Pull off pen cap.
Check Victoza®in the
cartridge. The liquid
should be clear, colorless,
and free of particles.
If not, do not use.
Wipe the rubber stopper
with an alcohol swab.
Remove protective tab
from outer needle cap.
Push outer needle cap
containing the needle
straight onto the pen,
then screw needle on
until secure.
Pull off outer needle cap.
Do not throw away. Pull off inner needle cap
and throw away. A small
drop of liquid may appear.
This is normal.
Preparing Your Pen
Flow
check
symbol
selected
0.6 mg
selected
1.2 mg
selected
1.8 mg
selected
If you have questions about using your Victoza®pen, call toll-free 1-877-484-2869 or visit victoza.com.
Please see Important Safety Information, including Boxed Warning, and Prescribing Information and
Medication Guide, enclosed or at www.Victoza.com.
First-Time Use for Each New Pen
Hold pen with needle
pointing up.
Tap cartridge gently
with your finger a few
times to bring any air
bubbles to the top of
the cartridge.
Keep needle pointing up
and press dose button
until 0 mg lines up with
pointer. Repeat this up to
6 times, until a drop of
Victoza®appears at the
needle tip.
If you still see no drop of
Victoza®, use a new pen
and contact Novo Nordisk
at 1-877-484-2869.
After setting up a new
pen, follow these steps
Turn dose selector until flow
check symbol (--) lines up
with pointer. The flow check
symbol does not administer
the dose as prescribed by
your health care provider.
You only need to do this
ONCE for each new pen and
it is ONLY required the first
time you use a new pen.
If this is the
first time
with a new
pen, follow
these steps
If you have
already used
your pen, follow
these steps
Routine Use. Prepare your Victoza®pen for injection
as described in the “Preparing Your Pen” section. The
“First-Time Use for Each New Pen” section should only
be performed when a new pen is used for the first time.
Routine Use and Injecting the Dose
Injecting the Dose. Insert needle into your skin in the stomach, thigh, or upper arm. Use the injection
technique shown to you by your health care provider. Do not inject Victoza®into a vein or muscle.
Dial the Dose. Victoza®pen can give a dose of 0.6 mg
(starting dose), 1.2 mg, or 1.8 mg. Be sure that you
know the dose of Victoza®that is prescribed for you.
Turn the dose selector until your needed dose lines up
with the pointer (0.6 mg, 1.2 mg, or 1.8 mg). You will
hear a “click” every time you turn the dose selector.
Do not set the dose by counting the number of
clicks you hear.
If you select a wrong dose, change it by turning the
dose selector backwards or forwards until the correct
dose lines up with the pointer. Be careful not to press
the dose button when turning the dose selector. This
may cause Victoza®to come out.
Withdraw Needle
You may see a drop of Victoza®
at the needle tip. This is normal
and it does not affect the dose
you just received. If blood
appears after you take the
needle out of your skin, apply
light pressure, but do not rub
the area.
Carefully put the outer needle
cap over the needle. Unscrew
the needle. Safely remove the
needle from your Victoza®pen
after each use.
Place used needles in a closeable,
puncture-resistant container. If
your Victoza®pen is empty or if
you have been using it for 30
days (even if it is not empty),
throw away the used pen. You
may use a sharps container (such
as a red biohazard container), a
hard plastic container (such as
an empty detergent bottle), or
metal container with a screw top
(such as an empty coffee can).
Ask your health care provider
for instructions on the right way
to dispose of your used needles,
pens, and the container. Do not
throw the disposal container
in the household trash. Do
not recycle.
0
mg
6
Keep the dose button pressed down and make sure that you keep
the needle under the skin for a full count of 6 seconds to make sure
the full dose is injected. Keep your thumb on the injection button
until you remove the needle from your skin.
Rotate your injection sites within the area you choose for each dose.
Do not use the same injection site for each injection.
Press down on the center
of the dose button to inject until
0 mg lines up with the pointer.
Be careful not to touch the dose
display with your other fingers.
This may block the injection.