6 mg/ml solution for injection in a pre-filled injection
pen liraglutide
What Victoza® is and what it is used for
Victoza contains the active substance liraglutide. It helps the body lower your blood sugar, but only when it is too high. It also makes food pass through the stomach more slowly and can help prevent heart disease.
Victoza is used as the only medicine if diet and exercise alone are not enough to control your blood sugar, and you cannot use metformin (another diabetes medicine).
Victoza is used with other diabetes medicines when these alone are not enough to get your blood sugar under control. These can be:
- diabetes medicines that you swallow (such as metformin, pioglitazone, sulphonylurea, sodium-glucose transporter 2 inhibitors (SGLT2i), and/or insulin.
What you need to know before you use Victoza®
Do not use Victoza
- if you are allergic to liraglutide or any of the other ingredients 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.
This medicine should not be used if you have type 1 diabetes (your body does not produce insulin ) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increased effort to breathe). It is not insulin and therefore should not be used as a substitute for insulin.
Use of Victoza is not recommended if you are undergoing dialysis.
Use of Victoza is not recommended if you have severe liver disease.
Victoza is not recommended if you have severe heart failure.
This medicine is not recommended if you have severe stomach or intestinal problems that cause slow gastric emptying (so-called gastroparesis) or inflammatory bowel disease.
If you have symptoms of acute inflammation of the pancreas, such as persistent, severe stomach pain, you should consult a doctor immediately (see section 4).
If you have thyroid disease including thyroid nodules and enlarged thyroid, consult a doctor.
When you start using Victoza, in some cases, if you experience vomiting, nausea and diarrhea, you may lose fluids and become dehydrated. It is essential to avoid dehydration, which is why you should drink plenty of fluids. Contact your doctor if you have any questions or concerns.
Children and young people
Victoza can be used in adolescents and children from the age of 10. No data are available for children under 10 years of age.
Other medicines and Victoza®
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking medicines that contain any of the following active substances, you should tell your doctor, pharmacist, or nurse:
- A sulphonylurea (eg glimepiride or glibenclamide) or insulin. You may experience hypoglycemia (low blood sugar) if you use Victoza with sulphonylurea or insulin, as they increase the risk of low blood sugar. When you start using these medicines together, your doctor may reduce your dose of the sulphonylurea or insulin et. See section 4 for information on warning signs of low blood sugar. If you are also taking a sulphonylurea (eg glimepiride or glibenclamide) or insulin, your doctor may tell you to check your blood sugar levels. This helps the doctor decide whether to dose of sulfonylurea or insulin needs to be changed.
- If you use insulin, your doctor will tell you how to reduce your insulin dose and recommend that you check your blood sugar more often to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough a lot of insulin ).
- Warfarin or other oral anticoagulants. You may be required to have more frequent checks of your blood’s clotting ability.
Pregnancy and breastfeeding
Tell the doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Victoza should not be used during pregnancy as it is not known whether it can harm your unborn baby.
It is not known whether Victoza passes into breast milk, so do not use this medicine if you are breastfeeding.
Driving ability and use of machinery
Low blood sugar can impair your ability to concentrate. Avoid driving or using machines if you experience insulin sensitivity. See section 4 for information on warning signs of low blood sugar. Consult your doctor for more information on this.
Important information about some of the ingredients in Victoza
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that this medicine is almost “sodium-free”.
How to use Victoza®
Always use this medicine as directed by your doctor. Consult a doctor, pharmacist, or nurse if you are unsure.
- The starting dose is 0.6 mg once daily for at least one week.
- The doctor will tell you when to increase the dose by one to 1.2 mg once daily.
- The doctor may increase the dose to 1.8 mg once daily if your blood sugar is not sufficiently controlled with the 1.2 mg dose.
The dose may only be changed on the doctor’s instructions.
Victoza is given as an injection under the skin ( subcutaneously ). Do not inject the medicine directly into a blood vessel or muscle. The best areas to inject are the front of the thighs, the front of the waist (abdomen), or the upper arm.
You can take an injection at any time during the day without regard to meals. Once you have worked out what time of day works best for you, you are advised to inject Victoza at around this time of day each day.
Before you use the injection pen for the first time, a doctor or nurse will show you how to use it.
On the back of this leaflet, there are detailed instructions for use.
If you have used too much Victoza®
Contact your doctor immediately if you use too much Victoza. You may need medical attention. You may feel nauseous, start vomiting, and have diarrhea, or have low blood sugar (hypoglycemia). See section 4 for information on warning signs of low blood sugar.
If you forget to use Victoza®
If you forget a dose, use Victoza as soon as you remember.
If it has been more than 12 hours since you should have used Victoza, skip the missed dose. Take the next dose, as usual, the following day.
Do not take a double or increased dose the following day to make up for the missed dose.
If you stop using Victoza®
Do not stop taking Victoza unless your doctor tells you to. If you stop using the medicine, your blood sugar level may rise.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Common: may affect up to 1 in 10 users
- Hypoglycemia (low blood sugar). Warning signs of low blood sugar can appear suddenly and appear as: cold sweat, cold and pale skin, headache, palpitations, nausea, strong hunger, vision changes, sleepiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, and tremors ( tremors ). The doctor talks about how to treat low blood sugar and what to do if you notice any of the warning signs. This is more likely to happen if you are also taking a medicine that contains sulphonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using Victoza.
Rare: may affect up to 1 in 1,000 users
- A severe form of an allergic reaction ( anaphylactic reaction ) with additional symptoms such as difficulty breathing, swelling of the throat and face, palpitations, etc. If you experience these symptoms, seek medical attention immediately and inform your doctor as soon as possible.
- Intestinal obstruction. A severe form of constipation with additional symptoms such as abdominal pain, tension, vomiting, etc.
Very rare: may affect up to 1 in 10,000 users
- Cases of inflammation of the pancreas ( pancreatitis ). Pancreatitis can be a serious and potentially life-threatening medical condition. Stop taking Victoza and contact your doctor immediately if you experience any of the following serious side effects: Severe and persistent pain in the abdomen (stomach), which may radiate to the back, as well as nausea and vomiting, as these may be signs of an inflamed pancreas ( pancreatitis ).
Other side effects ar
Very common: may affect more than 1 in 10 users
- Nausea. This usually goes away with time.
- Diarrhea. This usually goes away with time.
Usual
- Vomiting.
When you start using Victoza, in some cases, if you experience vomiting, nausea and diarrhea, you may lose fluids and become dehydrated. It isessentialt to avoid dehydration by drinking enough fluids.
- Headache
- Indigestion
- Stomach catarrh ( gastritis ). May manifest itself as stomach pain, nausea, and vomiting.
- Reflux disease ( GERD ). It can manifest itself as heartburn.
- Sore or swollen stomach (abdomen)
- Stomach upset
- Constipation
- Gas ( flatulence )
- Decreased appetite
- Bronchitis
- Cold
- Dizziness
- Increased heart rate
- Fatigue
- Toothache
- Injection site reactions (such as bruising, pain, irritation, itching, and rash).
- Increase in pancreatic enzymes (such as lipase and amylase).
Uncommon: may affect up to 1 in 100 users
- Allergic reactions such as itching and hives
- Dehydration, sometimes with reduced kidney function
- General malaise
- Gallstone
- Inflamed gallbladder
- A delay in gastric emptying.
How to store Victoza®
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the pen label and carton after EXP. The expiration date is the last day of the specified month.
Unopened:
Store in a refrigerator (2°C–8°C). Do not freeze. Do not store it near the freezer compartment.
During use:
The pen can be stored for 1 month at a maximum of 30°C or in a refrigerator (2°C–8°C), not near the freezer compartment. Do not freeze.
When the injection pen is not in use, it should be stored with the pen cap on. Light sensitive.
May only be used if the solution is clear and colorless or almost colorless.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is liraglutide. 1 ml of solution for injection contains 6 mg of liraglutide. One pre-filled pen contains 18 mg of liraglutide.
- Other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, and water for injections.
Appearance and package sizes of the medicine
Victoza is supplied as a clear and colorless or almost colorless solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, which gives 30 doses of 0.6 mg, 15 doses of 1.2 mg, or 10 doses of 1.8 mg.
Victoza is available in packs of 1, 2, 3, 5, or 10 pens. Not all pack sizes may be marketed.
Injection needles are not included.
Novo Nordisk A/S
Novo Allé
DK-2880 Bag Sword
Denmark