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Victoza

Liraglutide (rys)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Victoza. It does not contain all the available information. It does not take the place of talking to your doctor, diabetes educator/nurse or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Victoza against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Victoza is used for

Victoza contains the active ingredient liraglutide. Victoza is an injection that is used once a day.

Victoza is used to treat type 2 diabetes mellitus.

Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level.

If you have type 2 diabetes mellitus your body is also not able to use insulin properly.

Victoza helps your body to produce more insulin when your blood sugar level is high.

Victoza is used when previous medicines have not been enough to control your blood sugar levels. Your doctor may want you to use one or more other medicines in addition to Victoza, such as metformin or a sulfonylurea. It is also important to control your diet and exercise while using Victoza.

Victoza has not been studied in children.

Victoza is supplied as a pre-filled pen containing liraglutide. The Victoza pen can give 15 doses of 1.2mg or 10 doses of 1.8mg. The Victoza pen can also give starting doses of 0.6mg.

Victoza is not addictive.

Victoza is available only with a doctor’s prescription.

Ask your doctor, diabetes educator/nurse or pharmacist if you have any questions about why Victoza has been prescribed for you.

Before you use Victoza

When you must not use it

Do not use Victoza if:

  • You are allergic (hypersensitive) to liraglutide or to any of the ingredients listed in the “Ingredients” section of this leaflet.
Some of the symptoms of an allergic reaction may include:
- redness, swelling, rash and itching at the injection site;
- rash, itching or hives on the skin;
- shortness of breath;
- wheezing or difficulty breathing;
- swelling of the face, lips, tongue or other parts of the body.
  • You have had pancreatitis (an inflamed pancreas causing severe upper stomach pain) when using a GLP-1 analogue (such as liraglutide or exenatide).

If you are not sure whether you should start using this medicine, talk to your doctor.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

Tell your doctor if:

  • you are also taking a sulfonylurea (such as glimepiride or glibenclamide). Your doctor may tell you to test your blood sugar levels. This will help your doctor to decide if the dose of the sulfonylurea needs to be changed.
  • you have heart failure (disease of the heart with shortness of breath, and swelling of the feet or legs due to fluid build-up).
  • you have inflammatory bowel disease, such as Crohn's disease.
  • you have diabetic gastroparesis (a condition in which your stomach has difficulty in emptying food properly).
  • you currently have or have had thyroid disease.

Drink plenty of fluids to avoid dehydration if you experience vomiting or diarrhoea when beginning treatment with Victoza. Contact your doctor if you have any questions or concerns.

Victoza should not be used if you have type 1 diabetes or diabetic ketoacidosis. Victoza is not an insulin.

Victoza should not be used in children and adolescents under 18 years.

If you have or have had symptoms of acute pancreatitis, like persistent, severe abdominal pain, you should consult your doctor.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant. Use of this medicine in pregnancy has not been studied. Victoza should not be used during pregnancy. It is not known if Victoza may harm your unborn child.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if Victoza passes into breast milk. Do not use Victoza if you are breast-feeding.

If you have not told your doctor about any of the above, tell them before you use Victoza.

Taking other medicines

Tell your doctor, pharmacist or diabetes educator/nurse if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, tell your doctor if you are using medicines containing any of the following active ingredients:

  • Insulin. The combination of Victoza with insulin has not been evaluated.
  • A sulfonylurea (such as glimepiride or glibenclamide). This is because using Victoza at the same time may cause your blood sugar level to become too low (hypoglycaemia or a “hypo”).
    - When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea.
    - If you are not sure if the medicines you are taking contain a sulfonylurea, ask your doctor, diabetes educator/nurse or pharmacist.
    - If you are taking a sulfonylurea as well as Victoza, your doctor may ask you to test your blood sugar levels to begin with. This will help your doctor to decide if the dose of the sulfonylurea needs to be changed.
  • Warfarin or other types of medicines called ‘coumarin derivatives’. Your doctor may need to monitor you more closely.

Tell your doctor about any other medicines that you are taking. This is very important. Your doctor will advise you if it is alright to keep taking them or if you should stop taking them.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Victoza

Your doctor, diabetes educator/nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor, diabetes educator/nurse or pharmacist for help.

How much to use

Your doctor or diabetes educator/nurse will tell you how much of this medicine you need to use.

  • The usual starting dose is 0.6mg once a day.
  • Your doctor will tell you how long to keep taking this dose. It will be for at least one week.
  • Your dose may then be increased to 1.2mg once a day.
  • If your blood sugar level is not controlled with a dose of 1.2mg, your doctor may increase the dose to 1.8mg once a day.
  • Do not change your dose unless your doctor has told you to.

When to use it

You can use Victoza at any time of day. It is preferable to use Victoza at about the same time each day, at a time that is most convenient for you.

Victoza does not need to be taken with meals.

How to use it

  • Victoza is designed to be used with NovoFine or NovoTwist needles, up to a length of 8mm and as thin as 32G. Needles are not included with the pen.
  • Ask your doctor or diabetes educator/nurse which needle width (gauge) and length is best for you.
  • Use a new needle for each injection and dispose of it after use.
  • Inject Victoza under the skin (subcutaneous injection) as shown to you by your doctor or diabetes educator/nurse. Never inject Victoza into a vein or muscle.
  • Victoza may be injected into your abdomen, thigh, or upper arm.

Checking your Victoza pen:
Victoza should be clear and colourless.

Do not use this medicine if it is thickened, coloured, or has solid bits in it.

Read the instructions printed later in this leaflet carefully in order to prepare and handle your Victoza pen correctly.

How long to use it

Do not stop using Victoza unless your doctor tells you to.

If you use too much (overdose)

If you use more Victoza than you should, talk to your doctor straight away. You may need medical treatment. Overdose may cause nausea and vomiting.

If you forget to use it

If you forget a dose, use Victoza as soon as you remember.

However, if it is more than 12 hours since you should have used Victoza, skip the missed dose. Then take your next dose as usual the following day.

Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

If you are not sure what to do, talk to your doctor, diabetes educator/nurse or pharmacist.

While you are using Victoza

Things you must do

Make sure all friends, relatives, workmates or carers know that you have diabetes.

Tell your doctor if you often have hypos (low blood sugar levels). When Victoza is used with a medicine that contains a sulfonylurea, hypos can occur. The dose of your sulfonylurea may need to be reduced while you take Victoza.

Tell your doctor, diabetes educator/nurse or pharmacist if you are travelling. Ask them for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.

You may not be able to get Victoza in the country you are visiting.

Your doctor, diabetes educator/nurse or pharmacist can provide you with some helpful information.

Things you must not do

Do not stop using your medicine unless your doctor tells you to. If you stop using it, your blood sugar levels may increase.

Do not use the medicine if you think it has been frozen or exposed to excessive heat.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not share needles.

Things to be careful of

Do not stop using your medicine unless your doctor tells you to. While you are driving or using tools or machines, you should avoid getting low blood sugar (hypoglycaemia), because this may reduce your ability to concentrate. Your doctor will tell you how to do this.

Side effects

Tell your doctor, diabetes educator/nurse or pharmacist as soon as possible if you do not feel well while you are using Victoza. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor, diabetes educator/nurse or pharmacist to answer any questions you may have. The most common side effects when using Victoza are diarrhoea and nausea. These side effects are usually mild and normally decrease with continued use.

Tell your doctor if you notice any of the following and they worry you:

  • anorexia
  • decreased appetite
  • headache
  • vomiting
  • indigestion (dyspepsia)
  • burping, wind (flatulence) or constipation
  • heartburn
  • painful or swollen tummy (abdomen)
  • upper respiratory tract infection
  • low blood sugar (a hypo)
  • injection site reactions (such as bruising, pain, irritation, itching and rash)
  • fast heart beat

This list includes the more common side effects of your medicine. They are usually mild and short-lived.

Hypos are more likely to occur if you are also taking a sulfonylurea. A hypo may come on suddenly. The warning signs of a hypo can include:

  • cold sweat, cool pale skin
  • headache
  • fast heart beat
  • feeling sick
  • feeling very hungry
  • changes in vision
  • feeling sleepy
  • feeling weak, nervous, anxious, or confused
  • difficulty concentrating
  • shaking (tremor)

Your doctor can provide you with further information about how to treat low blood sugar levels and what to do if you notice these warning signs. If you are already taking a sulfonylurea when you start using Victoza, your doctor may tell you to reduce the dose of the sulfonylurea.

Tell your doctor immediately if you:

  • experience persistent, severe abdominal pain. This can be a symptom of acute pancreatitis. Pancreatitis can be a serious, potentially life-threatening medical condition.
  • get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Tell your doctor if you notice anything that is making you feel unwell.

Since the market introduction of Victoza®, additional side effects have been reported:

urticaria (a type of skin rash)dehydration, sometimes with a decrease in kidney function.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

skin rashes over a large part of the bodyshortness of breath, wheezingswelling of the face, lips or tonguefast pulsesweating

This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some people.

Ask your doctor, diabetes educator/nurse or pharmacist to answer any questions you have.

After using Victoza

Storage

Store Victoza pens that are not being used between 2°C and 8°C in a refrigerator (not in or too near the freezer section or cooling element).

When Victoza is being used you can keep the pen for 1 month either at room temperature (not above 30°C) or in a refrigerator (2°C to 8°C), away from the cooling element. Discard Victoza after 1 month even if there is still some medicine left in it.

The medicine in Victoza must not be frozen, or exposed to heat or direct sunlight. Protect the medicine in Victoza from light by keeping the pen cap on when not in use.

Never use Victoza after the expiry date printed on the pen label and carton.

Never use Victoza if the solution is not clear and colourless.

Keep out of the reach of children.

Disposal

Dispose of used needles safely into a yellow plastic sharps container. If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

Victoza is supplied as a clear, colourless solution for injection in a pre-filled pen. Each pen contains 3mL of solution, delivering 30 doses of 0.6mg, 15 doses of 1.2mg or 10 doses of 1.8mg.

Victoza is available in packs containing 1, 2 or 3 pens. Not all pack sizes may be marketed.

Ingredients

Victoza contains liraglutide (rys) 6mg/mL as the active ingredient. The abbreviation “rys” indicates the method of genetic engineering used to manufacture the liraglutide.

Victoza also contains the following inactive ingredients: dibasic sodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide and water for injections.

Sponsor

Victoza is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 3
21 Solent Circuit
Baulkham Hills NSW 2153

This leaflet was prepared on 17 May 2013.

Australian Registration Number:
AUST R 153980

Victoza, NovoFine, NovoTwist and NovoCare are trademarks owned by Novo Nordisk A/S.

© 2013

Further information

For further information call the NovoCare Customer Care Centre on 1800 668 626.

www.novonordisk.com.au

You can also get more information about diabetes from Diabetes Australia:
freecall helpline 1300 136 588
www.diabetesaustralia.com.au

Victoza

Liraglutide (rys)

Instructions For Use

Please read these instructions carefully before using your Victoza pen.

Your Victoza pen contains 18mg of liraglutide. You can select doses of 0.6mg, 1.2mg and 1.8mg.

Victoza pen is designed to be used with NovoFine or NovoTwist disposable injection needles up to a length of 8mm and as thin as 32G

Maintenance

Your Victoza pen is designed to work accurately and safely. It must be handled with care.

  • Do not try to repair your pen or pull it apart.
  • Keep your pen away from dust, dirt and all kinds of liquids.
  • Clean the pen with a cloth moistened with a mild detergent. Do not try to wash it, soak it or lubricate it – this can damage the pen.

Preparing your Victoza pen

  1. Pull off the pen cap.

  1. Pull off the paper tab from a NovoFine or NovoTwist needle. If using a NovoFine needle screw the needle onto your pen so that it is straight and secure. If using a NovoTwist needle, twist the needle onto your pen until a "click" is heard.

  1. Pull off the outer needle cap and keep it for later.

  1. Pull off the inner needle cap and dispose of it.

  • Always use a new needle for each injection.
  • Be careful not to bend or damage the needle before use.
  • Never put the inner needle cap back on once you have removed it from the needle. This reduces the risk of hurting yourself with the needle.

Checking the flow

Always check the flow as follows before you inject with a new pen.

  1. Turn the dose selector until the flow check symbol lines up with the pointer.

  1. Hold the pen with the needle pointing up. Tap the cartridge gently with your finger a few times. This will make any air bubbles collect at the top of the cartridge

  1. Keep the needle pointing up and press the dose button until 0mg lines up with the pointer. Repeat steps E to G until a drop of Victoza appears at the needle tip. If no drop appears after six times, change the needle and repeat steps E to G up to six more times. If you still see no drop of Victoza, the pen has failed to work and you must use a new one. Contact your diabetes educator/nurse and/or Novo Nordisk.

  • If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.

Selecting your dose

Always check that the pointer lines up with 0mg.

  1. Turn the dose selector until your required dose lines up with the pointer (0.6mg, 1.2mg or 1.8mg)

If you select an incorrect dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer. Be careful not to press the dose button when turning the dose selector backwards, as Victoza may come out.

If the dose selector stops before your required dose lines up with the pointer, there is not enough Victoza left for a full dose. Then you can either:

Divide your dose into two injections:
Turn the dose selector in either direction until 0.6mg or 1.2mg lines up with the pointer. Inject the dose. Prepare a new pen for injection and inject the remaining number of mg to complete your dose.

Inject the full dose with a new pen:
If the dose selector stops before 0.6mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.

  • The dose selector clicks when you turn it. You must not use these clicks to select the amount of Victoza to inject.
  • Do not use the cartridge scale to measure how much Victoza to inject – it is not accurate enough.
  • Do not try to select doses other than 0.6mg, 1.2mg or 1.8mg. The numbers in the display must line up precisely with the pointer to ensure that you get a correct dose.

Injecting the medicine

Insert the needle into your skin using the injection technique shown by your doctor or diabetes educator/nurse. Then follow the instructions below:

  1. Press the dose button to inject until 0mg lines up with the pointer. Be careful to only push the dose button when injecting. Turning the dose selector will not inject Victoza.
    Be careful not to touch the display with your other fingers or press the dose selector sideways when you inject. This is because it may block the injection.
    Keep the dose button pressed down and leave the needle under the skin for at least six seconds. This is to make sure that you get your full dose.

  1. Pull out the needle. After that, you may see a drop of Victoza at the needle tip. This is normal and has no effect on the dose you have just had.

  1. Guide the needle into the outer needle cap without handling the outer needle cap, as shown.

  1. When the needle is covered, carefully push the outer needle cap completely on. Then remove the needle by unscrewing it (for NovoFine needles) or with a twist (for NovoTwist needles). Carefully throw the needle away and put the pen cap back on. When the pen is empty, carefully throw it away without a needle attached. Dispose of pens and needles into a yellow plastic sharps container.

  • Always remove the needle after each injection and store your Victoza pen without a needle attached. Otherwise, the liquid may leak out, which can cause inaccurate dosing.
  • Health care professionals, relatives and other carers should follow general precautionary measures for removal and disposal of needles, to avoid hurting themselves with the needles.

Important information

  • Do not share your Victoza pen with anyone else.
  • Keep your Victoza pen out of reach of others, especially children.

Published by MIMS August 2013

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Cirrus Media Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.

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