VICTOZA- liraglutide injection, solution 
Novo Nordisk

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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 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?

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. Use the Victoza pen with Novo Nordisk disposable needles. 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 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 under certain types of stress. Tell your healthcare provider if you:
have fever
have trauma
have an infection
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 or insulin. In some people, the blood sugar may get so low that they need another person to help them. The dose of your sulfonylurea medicine or insulin 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.

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).
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.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-877-484-2869

Issued: April 2013

Version: 4

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, 7,235,627, 8,114,833 and other patents pending.

Victoza® pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending.

© 2010-2013 Novo Nordisk

PATIENT INSTRUCTIONS FOR USE

Victoza (liraglutide [rDNA origin]) injection

Victoza Pen and Needle

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 healthcare provider about your medical condition or your treatment.

Your Victoza pen contains 3 mL 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 healthcare provider will tell you how much Victoza to take.

Victoza pen should be used with Novo Nordisk disposable needles. Talk to your healthcare provider or pharmacist for more information about needles for your Victoza pen.

Important Information

Do not share your Victoza pen or needles with anyone else. You may give an infection to them or get an 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” (steps A through D).
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 the first time.

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.
Figure: Replace the Pen Cap
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.

How should I store Victoza?

Before use:

Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
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.

Pen in use:

Store your Victoza pen for 30 days 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).
If Victoza has been exposed to temperatures above 86ºF (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.

First Time Use for Each New Pen

Step A. Check the Pen

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.
Figure: 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.

Step B. Attach the Needle

Remove protective tab from outer needle cap.
Push outer needle cap containing the needle straight onto the pen, then screw needle on until secure.
Figure: Attaching Needle
Pull off outer needle cap. Do not throw away.
Figure: Remove Outer Needle Cap
Pull off inner needle cap and throw away. A small drop of liquid may appear. This is normal.
Figure: Remove Inner Needle Cap

Step C. Dial to the Flow Check Symbol

This step is done only ONCE for each new pen and is ONLY required the first time you use a new pen.

Turn dose selector until flow check symbol (- --) lines up with pointer. The flow check symbol does not administer the dose as prescribed by your healthcare provider.
To select the dose prescribed by your healthcare provider, continue to Step G under “Routine Use”.
Figure: Turn Dose Selector to Flow Check Symbol

Step D. Prepare the 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.
Figure: Tap Cartridge Gently with Finger
Keep needle pointing up and press dose button until 0 mg lines up with pointer. Repeat steps C and D, 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.

Continue to Step G under "Routine Use" →

Figure: Keep Needle Pointing Up and Press Dose Button

Routine Use

Step E. Check the Pen

Take your Victoza pen from where it is stored.
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.
Figure: 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.

Step F. Attach the Needle

Remove protective tab from outer needle cap.
Push outer needle cap containing the needle straight onto the pen, then screw needle on until secure.
Figure: Attaching Needle
Pull off outer needle cap. Do not throw away.
Figure: Remove Outer Needle Cap
Pull off inner needle cap and throw away. A small drop of liquid may appear. This is normal.
Figure: Remove Inner Needle Cap

Step G. 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.
Figure: Turn Dose Selector To Dose
Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).
Figure: 0.6 mg, 1.2 mg and 1.8 mg Dose
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.

Step H. Injecting the Dose

Insert needle into your skin in the stomach, thigh or upper arm. Use the injection technique shown to you by your healthcare provider. Do not inject Victoza into a vein or muscle.
Figure: Delivering the Dose
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.
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.
Keep dose button pressed down for 6 seconds.
Change (rotate) your injection sites within the area you choose for each dose. Do not use the same injection site for each injection.

Step I. 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.
Figure: Withdraw the Needle

Step J. Remove and Dispose of the Needle

Carefully put the outer needle cap over the needle. Unscrew the needle.
Figure: Safely Remove 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 healthcare 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.

Revised: 04/2013
 
Novo Nordisk