VICTOZA

Patient Information Leaflet: Information for the User

Victoza 6 mg/ml injection solution in a pre-filled pen

liraglutide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Victoza is and what it is used for
2. What you need to know before using Victoza
3. How to use Victoza
4. Possible side effects
5. How to store Victoza
6. Contents of the pack and other information

1. What Victoza is and what it is used for

Victoza contains the active substance liraglutide, which helps the body lower blood sugar levels only when they are too high. In addition, it slows the passage of food through the stomach and may help prevent heart disease.
Victoza is used when diet and exercise alone do not provide adequate blood sugar control and metformin (another diabetes medicine) cannot be used.
Victoza is used together with other diabetes medicines when these are not sufficient to control your blood sugar levels. These include:

• Oral antidiabetic medicines (such as metformin, pioglitazone, sulphonylureas, sodium-glucose cotransporter-2 (SGLT2) inhibitors) and/or insulin.

2. What you should know before using Victoza

Do not use Victoza

• if you are allergic to liraglutide or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse:

• before using Victoza
• if you have or have had a disease of the pancreas.

If you are scheduled for surgery under anaesthesia, inform your doctor that you are taking Victoza.
This medicine must not be used if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes causing high blood sugar levels and increased breathing difficulties). It is not insulin and therefore must not be used as a substitute for insulin.
The use of Victoza is not recommended if you are undergoing dialysis.
The use of Victoza is not recommended if you have severe liver disease.
The use of Victoza is not recommended if you have severe heart failure.
The use of this medicine is not recommended if you have severe gastrointestinal disorders, which manifest as delayed gastric emptying (called gastroparesis) or inflammatory bowel disease.
If you experience symptoms of acute pancreatitis, such as severe and persistent stomach pain, you must consult your doctor immediately (see section 4).
If you have thyroid diseases, including nodules or enlargement of the thyroid gland, consult your doctor.
When starting treatment with Victoza, you may in some cases experience fluid loss/dehydration, for example due to vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking sufficient fluids. Contact your doctor if you have any doubts or questions.
Children and adolescents
Victoza can be used in adolescents and children aged 10 years and above. There are no data available in children below 10 years of age.
Other medicines and Victoza
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor, pharmacist or nurse if you are taking medicines containing any of the following active substances:

• Sulfonylureas (e.g. glimepiride or glibenclamide) or insulin. You may experience hypoglycaemia (low blood sugar) if you use Victoza together with a sulfonylurea or insulin, because sulfonylureas and insulin increase the risk of hypoglycaemia. When you start using these medicines together, your doctor may ask you to reduce the dose of the sulfonylurea or insulin. See section 4 for signs of low blood sugar. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor should monitor your blood sugar levels. This will help your doctor decide whether your dose of sulfonylurea or insulin needs to be changed.
• If you are using insulin, your doctor will advise you on how to reduce the insulin dose and will recommend more frequent blood glucose monitoring to prevent hyperglycaemia (high blood sugar levels) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose due to insufficient insulin).
• Warfarin or other oral anticoagulant medicines. Frequent blood tests are needed to determine your blood’s ability to clot.

Pregnancy and breastfeeding
Inform your doctor if you are, or think you may be, pregnant, or if you are planning a pregnancy. Victoza must not be used during pregnancy because it is not known whether it could harm your unborn baby.
It is not known whether Victoza passes into breast milk; therefore, do not use this medicine if you are breastfeeding.
Driving and using machines
Low blood sugar (hypoglycaemia) may impair your ability to concentrate. Avoid driving or operating machinery if you experience symptoms of hypoglycaemia. See section 4 for warning signs of low blood sugar. Consult your doctor for further information on this topic.
Important information about some of the ingredients of Victoza
This medicine contains less than 1 mmol of sodium (23 mg) per dose. Therefore, it is essentially ‘sodium-free’.

3. How to use Victoza

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.

• The starting dose is 0.6 mg once daily for at least one week.
• Your doctor will tell you when to increase the dose to 1.2 mg once daily.
• Your doctor may instruct you to further increase the dose to 1.8 mg once daily if your blood sugar level is not adequately controlled with the 1.2 mg dose. Do not change the dose unless your doctor tells you to do so.

Victoza is administered by subcutaneous injection (under the skin). Do not inject it into a vein or muscle.
The best injection sites are the front of the thighs, the abdomen (stomach), or the upper arm. Change the injection site each day to reduce the risk of developing lumps.
You may administer the injection at any time of day, regardless of meals. Once you have chosen the most convenient time, it is preferable to inject Victoza approximately at the same time each day.
Before using the pen for the first time, your doctor or nurse will show you how to do it.
Detailed instructions for use are provided on the reverse of this leaflet.

If you use more Victoza than you should
If you use more Victoza than prescribed, inform your doctor immediately, as you may require medical treatment. You may experience nausea, vomiting, diarrhoea, or low blood sugar (hypoglycaemia). See section 4 for warning signs of low blood sugar.

If you forget to use Victoza
If you miss a dose, take Victoza as soon as you remember.
However, if more than 12 hours have passed since you were supposed to take Victoza, skip the missed dose and take the next dose at the usual time the following day.
Do not use a double dose or increase the dose the next day to make up for the missed dose.

If you stop using Victoza
Do not stop using Victoza without first discussing it with your doctor. If you stop treatment, your blood sugar levels may rise.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Common: affects up to 1 in 10 people

• Hypoglycaemia (low blood sugar level). Warning signs of low blood sugar may occur suddenly and may include: cold sweating, cold and pale skin, headache, rapid heartbeat, feeling unwell (nausea), intense hunger, vision changes, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, trembling. Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these warning signs. This is what may happen if you are taking a sulphonylurea or insulin. Before you start using Victoza, your doctor may reduce the dose of these medicines.
  Rare: affects up to 1 in 1,000 people

• A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing difficulties, swelling of the throat and face, rapid heartbeat, etc. If you experience these symptoms, you must seek immediate medical help and inform your doctor as soon as possible.

• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.

Very rare: affects up to 1 in 10,000 people

• Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious medical condition that may be life-threatening. If you experience any of the following serious side effects, stop using Victoza and contact your doctor immediately:

Severe and persistent pain in the abdomen (stomach area) that may extend to the back, as well as nausea and vomiting, may be signs of inflammation of the pancreas (pancreatitis).
Other side effects
Very common: affects more than 1 in 10 people

• Nausea (feeling unwell). This usually goes away over time.
• Diarrhoea. This usually goes away over time.

Common

• Vomiting.

When you start treatment with Victoza, you may in some cases lose fluids/dehydrate, for example due to vomiting, nausea, and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Inflammation of the stomach (gastritis). Signs include stomach pain, nausea, and vomiting.
• Gastroesophageal reflux disease (GORD). Signs include heartburn.
• Pain or swelling in the abdomen (stomach area)
• Abdominal discomfort
• Constipation
• Intestinal gas (flatulence)
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased heart rate
• Fatigue
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching, and skin rash).
• Increased levels of pancreatic enzymes (such as lipase and amylase).

Uncommon: affects up to 1 in 100 people

• Allergic reactions such as itching and hives (a type of skin rash).
• Dehydration, sometimes with reduced kidney function
• Malaise (feeling unwell)
• Gallstones
• Inflammation of the gallbladder
• Change in the way things taste
• Delayed stomach emptying.

Not known: frequency cannot be estimated from the available data

• Subcutaneous nodules may be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is not known).

Reporting of side effects
If you experience any side effects, inform your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Victoza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and packaging after 'EXP'. The expiry date refers to the last day of the month.
Before opening:
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the freezer compartment.
During use:
The pen can be stored for 1 month at temperatures below 30°C or in the refrigerator (2°C – 8°C), away from the freezer compartment. Do not freeze.
When not in use, store the pen with the cap on to protect the product from light.
Do not use the medicine if the solution is not clear and colourless or almost colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Victoza contains

• The active substance is liraglutide. 1 ml of injectable solution contains 6 mg of liraglutide. A pre-filled pen contains 18 mg of liraglutide.
• The excipients are disodium phosphate dihydrate, propylene glycol, phenol, water for injections.

Description of the appearance of Victoza and contents of the pack
Victoza is supplied as a clear, colourless or almost colourless, injectable solution in a pre-filled pen. Each pen contains 3 ml of solution, corresponding to 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Victoza is available in packs containing 1, 2, 3, 5 or 10 pens. Not all pack sizes may be marketed.
Needles are not included.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé,
DK-2880 Bagsværd,
Denmark
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USING THE VICTOZA PEN. Read these instructions carefully before using your pen. The pen contains 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg, and 1.8 mg. The pen is designed to be used with NovoFine and NovoTwist disposable needles up to 8 mm in length and as thin as 32 G (0.25/0.23 mm).
Preparing the pen Check the name and the colored label on the pen to make sure it contains liraglutide. Using the wrong medicine can seriously harm you. Remove the cap from the pen.
Remove the protective seal from a new disposable needle. Screw the needle firmly and straight onto your pen.
Remove the outer needle cap and keep it for later use.
Remove the inner needle cap and discard it.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles, and inaccurate dosing. Be careful not to bend or damage the needle. Never attempt to reattach the inner needle cap after removing it, as you may injure yourself with the needle.
Pen maintenance • Do not attempt to repair or disassemble the pen. • Store the pen away from dust, dirt, and any kind of liquid. • Clean the pen with a cloth dampened with a mild detergent. • Do not try to wash, immerse in liquid, or lubricate the pen—this may damage it.

Important information • Do not share the pen or needles with anyone else. • Keep the pen out of reach of others, especially children. • Change the injection site daily to reduce the risk of developing lumps.
Check the flow with a new penCheck the flow before injecting with a new pen. If the pen has already been used, go directly to “Dose selection” step H. Rotate the dose selector until the flow check symbol aligns with the indicator.
Hold the pen with the needle pointing upward. Gently tap the cartridge several times with your finger so that air bubbles collect at the top of the cartridge.
With the needle pointing upward, press the injection button until the indicator aligns with 0 mg. A drop of liraglutide should appear at the tip of the needle. If no drop appears, repeat steps E to G up to four times. If still no drop appears, replace the needle and repeat steps E to G once more. If no drop of liraglutide appears after this, do not use the pen. This indicates the pen is faulty and a new pen must be used.
If the pen has been dropped or hit against a hard surface, or if you suspect it is faulty, always attach a new single-use needle and check the flow before injecting.
Dose selection Always verify that the indicator is aligned with 0 mg. Rotate the dose selector until the required dose aligns with the indicator (0.6 mg, 1.2 mg, or 1.8 mg). If you have selected the wrong dose by mistake, correct it by rotating the dose selector forward or backward until the indicator aligns with the correct dose. Be careful not to press the injection button while rotating the dose selector backward, as this may cause liraglutide to leak out. If the dose selector stops before the required dose aligns with the indicator, this means there is not enough liraglutide left in the cartridge for a full dose. In this case, you may: Divide your dose into two injections: Rotate the dose selector forward or backward to align the indicator with 0.6 mg or 1.2 mg. Inject the dose. Then prepare a new pen for injection and inject the remaining mg to complete your dose. You may only split the dose between the current pen and a new pen if instructed by your healthcare provider. Use a calculator to plan your doses. If you split the dose incorrectly, you may inject too much or too little liraglutide. Inject the full dose with a new pen: If the dose selector stops before the indicator reaches 0.6 mg, prepare a new pen and administer the full dose using the new pen.
Do not attempt to select doses other than 0.6 mg, 1.2 mg, or 1.8 mg. The numbers on the display must align precisely with the indicator to ensure the correct dose is delivered. As you rotate the dose selector, you will hear clicks. Do not use these clicks as a guide for measuring the amount of liraglutide to inject. Do not use the cartridge’s graduated scale to measure the amount of liraglutide to inject, as it is not sufficiently accurate.
Injecting the dose Insert the needle into the skin using the injection technique shown by your doctor or nurse. Then follow the instructions below: Press the injection button until the indicator aligns with 0 mg. Be careful not to touch the display with other fingers or press the side of the dose selector during injection. This could
block the injection. Keep holding the injection button and leave the needle under the skin for at least 6 seconds. This ensures the full dose is delivered.
Remove the needle from the skin. You may see a drop of liraglutide at the tip of the needle afterward. This is normal and does not affect the administered dose.
Insert the needle tip into the outer needle cap without touching the needle or the cap.
Once the needle is covered, press the outer cap down completely and carefully, then unscrew the needle. Dispose of the needle properly and replace the cap on the pen. When the pen is empty, discard it carefully without the needle attached. Dispose of the pen and needle according to local regulations.
Always remove the needle after each injection and store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles, and inaccurate dosing. Anyone assisting the patient must handle used needles with extreme care to prevent cross-infection and needle-stick injuries.