Victoza Pre-filled Pen (Liraglutide)

Do not use VICTOZA if:

• You or a member of your family has ever had medullary thyroid cancer.
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You are allergic to any of the ingredients in VICTOZA.
• You are pregnant or breastfeeding.

Talk about any health conditions or problems you may have, including if you:

• Or a member of your family has or has had medullary thyroid carcinoma, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have type 1 diabetes.
• Have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
• Have ever had an allergic reaction to VICTOZA.
• Have a high heart rate (fast pulse).
• Have a condition called heart block.
• Have any heart disease, such as angina, heart rhythm disturbances or congestive heart failure; or if you have ever had a myocardial infarction (heart attack).
• Have kidney problems.
• Have liver problems.
• Have gastrointestinal (digestive) problems.
• Have ever had pancreatitis.
• Are breastfeeding or plan to breastfeed.
• Are pregnant or plan to become pregnant.
• Have severe vomiting and/or diarrhea and/or dehydration.

When initiating treatment with VICTOZA, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhea. It is important to avoid dehydration by drinking plenty of fluids. Worsening of renal function may sometime require hemodialysis. Contact your doctor if you have any questions or concerns.

VICTOZA may increase heart rate and could cause changes known as PR prolongation, which are detected by electrocardiogram (ECG) tracings. Increased heart rate is the same as a faster pulse. Rarely, drugs with these effects can cause changes in heart rhythm that could result in dizziness, palpitations (a feeling of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm changes are more likely if you have heart disease, or if you are taking certain other drugs. It is important to follow your doctor's advice about the dose of VICTOZA or about any special tests that you may need.

VICTOZA is not recommended for use in children under 18 years of age.Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

In particular, tell your doctor, Diabetes Nurse Educator or pharmacist if you are using any of the following medicines for diabetes:

• A sulfonylurea medicine (such as glibenclamide or glimepiride). This is because using VICTOZA at the same time may cause your blood sugar to get too low (hypoglycemia).
• When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea medicine.
• Insulin. You may get hypoglycemia (low blood sugar) when using VICTOZA with insulin as insulin increases the risk of hypoglycemia
• If you are not sure if the medicines you are taking contain a sulfonylurea, ask your doctor, Diabetes Nurse Educator or pharmacist.

Like all medicines, VICTOZA can cause side effects. The following side effects may happen with this medicine.

Very common (affect more than 1 in 10 people)

• Feeling sick (nausea). This usually goes away over time.
• Diarrhea.

Common (affects less than 1 in 10 people)

• Low blood sugar (hypoglycemia). This is usually mild. It is more likely if you are also taking a medicine for diabetes called a sulfonylurea. The warning signs of low blood sugar may come on suddenly. They 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 will tell you how to treat low blood sugar and what to do if you notice these warning signs. If you are already taking a sulfonylurea medicine when you start using VICTOZA, your doctor may tell you to reduce the dose of the sulfonylurea. While you are driving or using tools or machines, you should avoid getting low blood sugar (hypoglycemia), because this may reduce your ability to concentrate.
• Anorexia.
• Decreased appetite.
• Headache.
• Being sick (vomiting).
• Burping.
• Indigestion.
• Inflamed stomach (gastritis). The signs include stomach pain, feeling sick (nausea) and being sick (vomiting).
• Gastro-esophageal reflux disease (GERD). The signs include heartburn.
• Painful or swollen tummy (abdomen).
• Constipation.
• Wind (flatulence).
• Infection of the upper airways.
• Injection site reactions (such as bruising, pain, irritation, itching and rash).
• Increased heart rate.

Since the market introduction of VICTOZA, cases of urticaria (a type of skin rash) have been reported.

The following list includes some, but not all, of the drugs that may increase the risk of heart rhythm problems while receiving VICTOZA. You should check with your doctor or pharmacist before taking any other medication with VICTOZA:

• Drugs to treat hypertension.
• Drugs to treat heart failure.
• Drugs to treat HIV infection.
• Drugs to treat attention deficit-hyperactivity disorder.
• Drugs to suppress appetite/cause weight loss.
• Decongestants.
• Drugs to treat asthma.

VICTOZA is an injection which is given under the skin (subcutaneously). Do not inject it into a vein or muscle. Before you use the pen for the first time, your doctor or Diabetes Nurse Educator will show you how to use it. The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen) or your upper arm. You can give yourself the injection at any time of the day Do not share your VICTOZA pen with anyone else, even if the needle is changed. Do not reuse or share needles with another person including family members. You may give another person an infection or get an infection from them.

Overdose:

If you think you have taken too much VICTOZA, contact your health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you use more VICTOZA than you should, talk to your doctor straight away. You may need medical treatment. If you use too much VICTOZA you may feel sick (have nausea) or become sick (vomit).

Missed Dose:

If a dose of VICTOZA is missed take your dose on the next day as usual. Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

Do not stop using VICTOZA without talking to your doctor. If you stop using it, your blood sugar levels may increase.