Victosa

From: www.victoza.com

Medication Guide
Victoza® (VIC-tow-za)
(liraglutide [rDNA origin])

Injection
Read this Medication Guide and Patient Instructions for Use that come with
Victoza before you start using Victoza and each time you get a refill. There may
be new information. This Medication Guide does not take the place of talking
with your healthcare provider about your medical condition or your treatment. If
you have questions about Victoza after reading this information, ask your
healthcare provider or pharmacist.
What is the most important information I should know about Victoza?
Serious side effects may happen in people who take Victoza, including:
1. Possible thyroid tumors, including cancer. During the drug testing
process, the medicine in Victoza caused rats and mice to develop tumors of
the thyroid gland. Some of these tumors were cancers. It is not known if
Victoza will cause thyroid tumors or a type of thyroid cancer called medullary
thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to
death if not detected and treated early. If you develop tumors or cancer of the
thyroid, your thyroid may have to be surgically removed.
• Before you start taking Victoza, tell your healthcare provider if you or
any of your family members have had thyroid cancer, especially
medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome
type 2. Do not take Victoza if you or any of your family members have
medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia
syndrome type 2. People with these conditions already have a higher
chance of developing medullary thyroid cancer in general and should
not take Victoza.
• While taking Victoza, tell your healthcare 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.
2. Inflammation of the pancreas (pancreatitis), which may be severe and lead
to death.
Before taking Victoza, tell your healthcare provider if you have had:
• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
These medical conditions can make you more likely to get pancreatitis in
general. It is not known if having these conditions will lead to a higher chance
of getting pancreatitis while taking Victoza.
While taking Victoza:
Stop taking Victoza and call your healthcare provider right away if you have pain
in your stomach area (abdomen) that is severe and will not go away. The pain
may happen with or without vomiting. The pain may be felt going from your
abdomen through to your back. This type of pain may be a symptom of
pancreatitis.
What is Victoza?
• Victoza is an injectable prescription medicine that may improve blood sugar
(glucose) in adults with type 2 diabetes mellitus, and should be used along
with diet and exercise.
• Victoza is not recommended as the first choice of medication for treating
diabetes.
• Victoza is not insulin.
• It is not known if Victoza is safe and effective when used with insulin.
• Victoza is not for use in people with type 1 diabetes or people with diabetic
ketoacidosis.
• It is not known if Victoza is safe and effective in children. Victoza is not
recommended for use in children.
Who should not use Victoza?
Do not use Victoza if:
• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a
disease where people have tumors in more than one gland in their body.
Talk with your healthcare provider if you are not sure if you have any of these
conditions.
What should I tell my healthcare provider before using Victoza?
Before taking Victoza, tell your healthcare provider if you:
• have any of the conditions listed in the section “What is the most important

information I should know about Victoza?”
• are allergic to liraglutide or any of the other ingredients in Victoza. See the
end of this Medication Guide for a list of ingredients in Victoza.
• have severe problems with your stomach, such as slowed emptying of your
stomach (gastroparesis) or problems with digesting food.
• have or have had kidney or liver problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Victoza will harm
your unborn baby. Tell your healthcare provider if you become pregnant while
taking Victoza.
• are breastfeeding or plan to breastfeed. It is not known if Victoza passes into
your breast milk. You and your healthcare provider should decide if you will
take Victoza or breastfeed. You should not do both without talking with your
healthcare provider first.
Tell your healthcare provider about all the medicines you take including
prescription and non-prescription medicines, vitamins, and herbal supplements.
Victoza slows stomach emptying and can affect medicines that need to pass
through the stomach quickly. Victoza may affect the way some medicines work
and some other medicines may affect the way Victoza works. Tell your
healthcare provider if you take other diabetes medicines, especially sulfonylurea
medicines or insulin.
Know the medicines you take. Keep a list of them with you to show your
healthcare provider and pharmacist each time you get a new medicine.

How should I use Victoza?
• Use Victoza exactly as prescribed by your healthcare provider. Your dose
should be increased after using Victoza for one week. After that, do not
change your dose unless your healthcare provider tells you to.
• Victoza is injected 1 time each day, at any time during the day.
• You can take Victoza with or without food.
• Victoza comes in a prefilled pen.
• Your healthcare provider must teach you how to inject Victoza before you use
it for the first time. If you have questions or do not understand the
instructions, talk to your healthcare provider or pharmacist. See the Patient
Instructions for Use that come with this Medication Guide for detailed
information about the right way to use your Victoza pen.
• Pen needles are not included. You may need a prescription to get pen
needles from your pharmacist. Ask your healthcare provider which needle
size is best for you.
• When starting a new prefilled Victoza pen, you must follow the “First Time
Use for Each New Pen” (see the detailed Patient Instructions for Use that
comes with this Medication Guide). You only need to do this 1 time with each
new pen. You should also do this if you drop your pen. If you do the “First
Time Use for Each New Pen” before each injection, you will run out of
medicine too soon.
• Inject your dose of Victoza under the skin (subcutaneous injection) in your
stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by
your healthcare provider. Do not inject into a vein or muscle.
• If you take too much Victoza, call your healthcare provider right away. Too
much Victoza may cause severe nausea and vomiting.
• Follow your healthcare provider’s instructions for diet, exercise, how often to
test your blood sugar, and when to get your HbA1c checked. If you stop using
Victoza your blood sugar levels may increase. First talk to your healthcare
provider if you want to stop taking Victoza.
• Your dose of diabetes medicines may need to be changed if your body is
under certain types of stress. Tell your healthcare provider if you:
o have fever
o have trauma
o have an infection
o plan to have or have had surgery
• Never share your Victoza pen or needles with another person. You may give
an infection to them, or get an infection from them.
What are the possible side effects of Victoza?
Victoza may cause serious side effects, including:
• See “What is the most important information I should know about Victoza?”
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is
higher if you take Victoza with another medicine that can cause low blood
sugar, such as a sulfonylurea. In some people, the blood sugar may get so
low that they need another person to help them. The dose of your
sulfonylurea medicine may need to be lowered while you use Victoza. Signs
and symptoms of low blood sugar may include:
• shakiness
• sweating
• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heartbeat
• feeling jittery
Talk to your healthcare provider about how to recognize and treat low blood
sugar. Make sure that your family and other people who are around you a lot
know how to recognize and treat low blood sugar.
Common side effects of Victoza include:
• headache
• nausea
• diarrhea
Nausea is most common when first starting Victoza, but decreases over time in
most people as their body gets used to the medicine.
Tell your healthcare provider if you have any side effect that bothers you or that
does not go away.
These are not all the side effects with Victoza. For more information, ask your
healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
How should I store Victoza?
Before use:
• Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF
(2ºC to 8ºC).
• Do not freeze Victoza or use Victoza if it has been frozen. Do not
store Victoza near the refrigerator cooling element.
Pen in use:
• Store your Victoza pen for 30 days either at 59ºF to 86ºF (15ºC to
30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C).
• When carrying the pen away from home, store the pen at a
temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.
• If Victoza has been exposed to temperatures above 86ºF (30ºC), 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 your Victoza pen within 30 days after the first day it is stored
outside the refrigerator. After these 30 days, throw away your Victoza
pen even if some medicine is left in the pen.
• Do not use Victoza after the expiration date printed on the carton.
Do not store the Victoza pen with the needle attached. Always safely
remove and safely throw away the needle after each injection. This may
help prevent contamination, infection and leakage. It also helps to make
sure that you get the correct dose of Victoza. See the Patient Instructions
for Use for information about how to dispose of used pen needles and
used Victoza pens.
Keep your Victoza pen, pen needles, and all medicines out of the reach of
children.

General information about Victoza
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use Victoza for a condition for which it was not
prescribed. Do not give Victoza to other people, even if they have the same
symptoms you have. It may harm them.
This Medication Guide summarizes the most important information you should
know about using Victoza. If you would like more information, talk with your
healthcare provider. You can ask your pharmacist or healthcare provider for
information about Victoza that is written for health professionals.
For more information, go to victoza.com or call 1-877-484-2869.
What are the ingredients in Victoza?
Active Ingredient: liraglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol
and water for injection
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Victoza contact:
Novo Nordisk Inc.
100 College Road West
Princeton, NJ 08540
1-877-484-2869
Issued: January 2010
Version: 1
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
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.
Victoza® pen is covered by US Patent Nos. 6,004,297, 6,235,004, 6,582,404 and
other patents pending.
© 2010 Novo Nordisk A/S