Victoza VIC tow za Liraglutide rDNA Origin Injection Instructions
- June 28, 2024
- Victoza
Table of Contents
VIC tow za Liraglutide rDNA Origin Injection
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Specifications
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Product Name: Victoza
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Type: Injectable prescription medicine
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Indicated for: Adults with type 2 diabetes mellitus
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Usage: To improve blood sugar levels along with diet and
exercise -
Not recommended for: Type 1 diabetes, diabetic ketoacidosis,
children
Product Usage Instructions
Before Starting Victoza:
Read the Medication Guide and Patient Instructions for Use that
come with Victoza before starting and each time you get a refill.
Discuss with your healthcare provider any questions or concerns you
may have.
Important Information:
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Do not take Victoza if you or any family members have a history
of medullary thyroid cancer or Multiple Endocrine Neoplasia
syndrome type 2. -
Inform your healthcare provider if you experience symptoms like
neck swelling, hoarseness, trouble swallowing, or shortness of
breath while taking Victoza. -
Prior medical conditions such as pancreatitis, gallstones,
alcoholism, or high blood triglyceride levels can increase the risk
of pancreatitis while on Victoza.
While Taking Victoza:
If you experience severe and persistent abdominal pain that may
radiate to your back, stop taking Victoza immediately and consult
your healthcare provider as this could be a symptom of
pancreatitis.
What is Victoza?
Victoza is an injectable prescription medicine for adults with
type 2 diabetes mellitus to help improve blood sugar levels when
used with diet and exercise. It is not a substitute for insulin and
not recommended for type 1 diabetes or diabetic ketoacidosis. Its
safety and effectiveness in children are not established.
Who Should Not Use Victoza?
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Avoid Victoza if you or family members have a history of
medullary thyroid cancer, Multiple Endocrine Neoplasia syndrome
type 2, or allergies to liraglutide or any ingredients in
Victoza. -
Not recommended for individuals with these conditions or
children.
Frequently Asked Questions (FAQ)
Q: Can Victoza be used as the first medication for treating
diabetes?
A: No, Victoza is not recommended as the initial choice of
medication for treating diabetes.
Q: Is Victoza safe for children?
A: Victoza is not recommended for use in children, and its
safety and effectiveness in this population are not
established.
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zyxw This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
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
zyxwvuts of getting pancreatitis while taking Victoza.
Reference ID: 312192363058
zyxwvutsr This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
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 a substitute for 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. you are
allergic to liraglutide or any of the ingredients in Victoza. See the end
of this Medication Guide for a complete list of ingredients in Victoza.
Symptoms of a serious allergic reaction may include:
o swelling of your face, lips, tongue, or throat o fainting or feeling dizzy o
very rapid heartbeat o problems breathing or swallowing o severe rash or
itching 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?
zyxwvuts Before taking Victoza, tell your healthcare provider if you:
Reference ID: 312192363058
This label may not be the latest approved by FDA. For current labeling
information, please visit https://www.fda.gov/drugsatfda
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
zyxwvuts 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.
zyxwvutsr Pen needles are not included. Use the Victoza pen with Novo Nordisk
disposable needles. You may need a prescription to get pen needles from
Reference ID: 312192363058
This label may not be the latest approved by FDA. For current labeling
information, please visit https://www.fda.gov/drugsatfda
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 also give yourself insulin injections in addition to Victoza, never mix
insulin and Victoza together. Give yourself 2 separate injections. You may
give both injections in the same body area (for example, your stomach area),
but you should not give the injections right next to each other.
If you take too much Victoza, call your healthcare provider right away. Too
much Victoza may cause severe nausea and vomiting.
If you miss your daily dose of Victoza, use Victoza as soon as you remember.
Then take your next daily dose as usual on the following day. Do not take an
extra dose of Victoza or increase your dose on the following day to make up
for your missed dose. If you miss your dose of Victoza for 3 days or more,
call your healthcare provider to talk about how to restart your treatment.
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
zyxwvuts 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
zyxwvutsr sugar, such as a sulfonylurea or insulin. In some people, the blood
sugar may
get so low that they need another person to help them. The dose of your
Reference ID: 312192363058
zyx This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
sulfonylurea medicine or insulin may need to be lowered while you use
Victoza. Signs and symptoms of low blood sugar may include:
shakiness
confusion
sweating
irritability
headache
hunger
drowsiness
fast heartbeat
weakness
feeling jittery
dizziness
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.
Kidney problems (kidney failure). Victoza may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.
Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth.
Serious allergic reactions. Serious allergic reactions can happen with Victoza. Stop using Victoza, and get medical help right away if you have any symptom of a serious allergic reaction See “Who should not use Victoza?”
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).
Reference ID: 312192363058
This label may not be the latest approved by FDA. For current labeling
information, please visit https://www.fda.gov/drugsatfda
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.
zyxwvut 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?
zyxwvutsr Active Ingredient: liraglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol
and water for injection
Reference ID: 312192363058
This label may not be the latest approved by FDA.
zyxwvuts For current labeling information, please visit
https://www.fda.gov/drugsatfda
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: XXX XX,
20XX Version: X 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. © 2010-2011 Novo Nordisk
zyxwvutsr
Reference ID: 312192363058
References
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