Trulicity 1,5 mg/0,5 ml Solution

TRULICITY is used to lower blood sugar (glucose) and reduce the risk of major cardiovascular events in adults with type 2 diabetes mellitus.

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. When this happens, sugar (glucose) builds up in the blood. TRULICITY is used when your blood sugar is not properly controlled by diet and exercise alone either on its own or with other medicines for diabetes, when other medicines are not enough to control your blood sugar levels. TRULICITY is used to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with type 2 diabetes mellitus with known heart disease or multiple cardiovascular risk factors. It is important to continue to follow the advice on diet and exercise given to you by your doctor or other healthcare professional.

Do not take TRULICITY:

• If you are hypersensitive (allergic) to dulaglutide or any of the other ingredients of TRULICITY (listed in section 6).
• If you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• If you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away.
• If you have type 1 diabetes (the type when your body does not produce any insulin) as TRULICITY may not be right for you.
• If you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
• If you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using TRULICITY if:

• you are on dialysis as TRULICITY is not recommended.
• you have type 1 diabetes (the type when your body does not produce any insulin) as TRULICITY may not be right for you.
• you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away.
• you are taking other medicines for your diabetes, as low blood sugar (hypoglycaemia) can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.

TRULICITY is not an insulin and should therefore not be used as a substitute for insulin.

Always use TRULICITY exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use it.

The recommended dose is 1,5 mg once a week. Each pen contains one weekly dose of TRULICITY (1,5 mg). You can use your TRULICITY at any time of the day, with or without meals. You should use it on the same day each week if you can. To help you remember, you may wish to tick the day of the week when you inject your first dose on the box that your TRULICITY comes in, or on a calendar.

TRULICITY is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh). If the injection is given by someone else, they may inject in your upper arm. If you want to do so, you can use the same area of your body each week. But be sure to choose a different injection site within that area.

It is important that you test your blood glucose levels as instructed by your doctor, pharmacist or nurse, if you are taking TRULICITY with a sulphonylurea or insulin.

Read the “Instructions for Use” for the pen carefully before using TRULICITY.

If you use more TRULICITY than you should talk to your doctor immediately. Too much TRULICITY may make your blood sugar too low (hypoglycaemia) and can make you feel sick or be sick.

If you forget to take TRULICITY If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject your dose as soon as possible. Inject your next dose on your regular scheduled day. If there are less than 3 days before your next dose is due, skip the dose and inject the next one on your regular scheduled day. Do not use a double dose to make up for a forgotten dose. You can also change the day of the week on which you inject TRULICITY if necessary, as long as it has been at least 3 days since your last dose of TRULICITY.

If you stop using TRULICITY Do not stop using TRULICITY without talking with your doctor. If you stop using TRULICITY, your blood sugar levels can increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

TRULICITY can cause side effects although not everybody gets them.

Severe side effects

Rare: (may affect up to 1 in 1 000 people)

• Severe allergic reactions (anaphylactic reactions, angioedema). You should see a doctor immediately if you experience symptoms such as rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulties breathing.
• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Not known: the frequency cannot be estimated from the available data:

• Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting. You should see a doctor immediately if you experience such symptoms.

Other side effects

Very common: may affect more than 1 in 10 people

• Nausea (feeling sick)
• Vomiting (being sick)
• Diarrhoea
• Abdominal (stomach) pain. These side effects are usually not severe. They are most common when first starting TRULICITY but decrease over time in most patients.
• Hypoglycaemia (low blood sugar) is very common when TRULICITY is used with medicines that contain metformin, a sulphonylurea and/or insulin.

Common: may affect up to 1 in 10 people

• Hypoglycaemia is common when TRULICITY is used alone, or with both metformin and pioglitazone together, or with a sodium-glucose co-transporter 2 inhibitor (SGLT2i) with or without metformin.
• Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar.
• Feeling less hungry (decreased appetite)
• Indigestion
• Constipation
• Gas (flatulence)
• Bloating of the stomach
• Gastroesophageal reflux disease - a disease caused by stomach acid coming up into the tube from your stomach to your mouth
• Burping
• Feeling tired
• Increased heart rate
• Slowing of the electrical currents in the heart

Uncommon: may affect up to 1 in 100 people

• Injection site reactions (e.g. rash or redness)
• Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives))
• Dehydration, often associated with nausea, vomiting and/or diarrhoea
• Gallstones
• Inflamed gallbladder

Rare: may affect 1 in 1 000 people

• A delay in the emptying of the stomach.

Reporting of side effects If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TRULICITY. Alternately, report suspected adverse events to the company at: [email protected]

Store all medicines out of the sight and reach of children. Do not use TRULICITY after the expiry date which is stated on the pen label and on the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original packaging in order to protect from light. TRULICITY can be taken out of the fridge for up to 14 days at a temperature not above 30 ºC. Do not use TRULICITY if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.

Do not throw away/dispose of any medicines via drains or sewerage systems (e.g. toilets). Return unused medicine to your pharmacist or ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.