Consumer Medicine Information
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.
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.
Do not use Victoza if:
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.
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.
Tell your doctor if:
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.
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:
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.
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.
Your doctor or diabetes educator/nurse will tell you how much of this medicine you need to use.
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.
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.
Do not stop using Victoza unless your doctor tells you to.
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 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.
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.
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.
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.
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:
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:
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:
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.
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.
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.
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.
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.
Victoza is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty. Ltd.
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.
For further information call the NovoCare Customer Care Centre on 1800 668 626.
You can also get more information about diabetes from Diabetes Australia:
freecall helpline 1300 136 588
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
Your Victoza pen is designed to work accurately and safely. It must be handled with care.
Always check the flow as follows before you inject with a new pen.
Always check that the pointer lines up with 0mg.
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.
Insert the needle into your skin using the injection technique shown by your doctor or diabetes educator/nurse. Then follow the instructions below:
Published by MIMS August 2013