TRIGLYVA

Package leaflet: Information for the patient

Triglyva, 6 mg/mL, solution for injection in a pre-filled pen
liraglutide
Please read this leaflet carefully before using this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What Triglyva is and what it is used for

What Triglyva is
Triglyva is a weight-loss medicine containing the active substance liraglutide. This substance mimics a naturally occurring hormone, glucagon-like peptide-1 (GLP-1), which is released from the intestines after a meal. Triglyva works by acting on receptors in the brain that regulate appetite, causing a feeling of fullness and reducing hunger sensations. This may help reduce food intake and lead to weight loss.

What Triglyva is used for
Triglyva is a weight-loss aid used together with diet and physical activity in adults aged 18 years and older who:

• have a BMI of 30 kg/m² or higher (obesity), or
• have a BMI of 27 kg/m² to less than 30 kg/m² (overweight) and have weight-related medical conditions (such as diabetes, high blood pressure, abnormal blood lipid levels, or a sleep breathing disorder called obstructive sleep apnoea).

Body Mass Index (BMI) is a measure of body weight relative to height.

Treatment with Triglyva should only be continued if at least a 5% reduction in initial body weight is achieved after 12 weeks of treatment at a dose of 3.0 mg/day (see section 3). To continue treatment, you must consult your doctor.

Triglyva may also be used as an addition to a healthy diet and increased physical activity for weight management in adolescents aged 12 years and older who have:

• obesity (diagnosed by a doctor), and
• body weight above 60 kg.

Treatment with Triglyva may only be continued if at least a 4% reduction in BMI is achieved after 12 weeks of treatment at a dose of 3.0 mg/day or at the maximum dose tolerated by the patient (see section 3). To continue treatment, you must consult your doctor.

Diet and exercise
Your doctor will start you on a diet and exercise programme. You should follow these recommendations throughout your treatment with Triglyva.

2. Important information before using Triglyva

When not to use Triglyva

• if the patient is allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Triglyva, discuss this with your doctor, pharmacist, or
nurse.
Use of Triglyva in patients with severe heart failure is not recommended.
Experience with use in patients aged 75 years and older is limited; therefore, use of this medicine is not recommended in patients aged 75 years and older.
Limited data are available on the use of this medicine in patients with renal impairment.
Patients with kidney function disorders or patients on dialysis should consult their
doctor.
Limited data are available on the use of this medicine in patients with hepatic impairment.
Patients with liver function disorders should consult their doctor.
Use of this medicine is not recommended in patients with severe stomach or intestinal disorders
causing delayed gastric emptying (gastroparesis) or inflammatory bowel disease.
If the patient is to undergo surgery under anaesthesia, the patient should inform the doctor
that they are using Triglyva.
Patients with diabetes
Patients with diabetes should not use Triglyva as a substitute for insulin.
Pancreatitis
If the patient has or has had pancreatic disease in the past, they should consult their
doctor.
Gallbladder inflammation and gallstones
During significant weight loss, the patient may be at risk of developing gallstones and, consequently, gallbladder inflammation. The patient should stop using Triglyva and consult a doctor immediately if they experience sudden severe pain in the upper part of the abdomen, usually stronger on the right side under the ribs. The pain may radiate to the back or right shoulder. See section 4.
Thyroid disease
In case of thyroid disease, including nodules or thyroid enlargement, consult a
doctor.
Heart rate
If palpitations (awareness of heartbeat) or a sensation of increased heart rate at rest occur during treatment with Triglyva, the patient should consult a doctor.
Fluid loss and dehydration
After starting treatment with Triglyva, loss of bodily fluids or dehydration may occur. This may be caused by nausea, vomiting, and diarrhoea. The patient should drink plenty of fluids to avoid dehydration. If in doubt or if you have any questions, consult your doctor, pharmacist, or nurse. See section 4.
Children
The safety and efficacy of Triglyva in children under 12 years of age have not been established.
Triglyva and other medicines
Inform your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor, pharmacist, or nurse if:

• the patient is taking antidiabetic medicines of the sulfonylurea class (such as glimepiride or glibenclamide) or insulin – low blood sugar (hypoglycaemia) may occur when Triglyva is used together with these antidiabetic medicines. To prevent low blood sugar, the doctor may adjust the dose of the antidiabetic medicine. See section 4 – symptoms indicating low blood sugar. If insulin dose adjustment is needed, the doctor may recommend more frequent blood sugar monitoring.
• the patient is taking warfarin or other oral anticoagulant medicines (blood thinners). More frequent blood tests to assess blood coagulation may be necessary.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
she should not use Triglyva. There are no data on the effects of Triglyva on the health
of the unborn child.
Breastfeeding should be avoided during treatment with Triglyva. There is no information on whether Triglyva passes into human milk.
Driving and using machines
Triglyva is likely to have no or negligible influence on the ability to drive and use machines.
In some patients using Triglyva, dizziness may occur, mainly during the first 3 months of treatment (see "Possible side effects"). If dizziness occurs, the patient should exercise particular caution when driving or operating machinery. For further information, consult your doctor.
Triglyva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning this medicine is considered "sodium-free".

3. How to use Triglyva

This medicine should always be used exactly as your doctor has told you. If you are not sure, you should consult your doctor, pharmacist, or nurse.
Your doctor will start by recommending a diet and exercise programme. You should follow these recommendations during treatment with Triglyva.

What dose of medicine should be injected
Adults
Treatment starts with a low dose, which should be gradually increased over the first five weeks of treatment.

• The starting dose of Triglyva is 0.6 mg once daily for at least one week.
• The dose should be gradually increased by 0.6 mg, as directed by your doctor, usually once a week, until the recommended dose of 3.0 mg once daily is reached.

Your doctor will inform you about the dose of Triglyva to be taken in the following weeks of therapy.
Usually, the dosing schedule recommended is as shown in the table below.
Week Injected dose
Week 1. 0.6 mg once daily
Week 2. 1.2 mg once daily
Week 3. 1.8 mg once daily
Week 4. 2.4 mg once daily
From Week 5 3.0 mg once daily
After reaching the recommended dose of 3.0 mg in week 5, this dose should be maintained until the end of treatment. Do not increase the dose further.
Your doctor will regularly assess your treatment results.

Children and adolescents (aged 12 years and above)
For children and adolescents aged 12 to 18 years, a similar dose escalation schedule as for adults should be used (see table above under Adults).
The dose should be gradually increased until a dose of 3.0 mg (maintenance dose) is reached or until the maximum dose tolerated by the patient is achieved. Daily doses higher than 3.0 mg are not recommended.

How and when to use Triglyva

• Before using the injection device for the first time, your doctor or nurse will show you how to use it.
• Triglyva can be taken at any time of day, with or without food or drink.
• You should take Triglyva approximately at the same time each day – you may choose the time most convenient for you.

Injection site
Triglyva should be injected under the skin (subcutaneous injection).

• The best injection sites are the front of the waist (abdomen), thigh, or upper arm.
• You should change the injection site each day to reduce the risk of lumps developing.
• Do not inject Triglyva into a vein or muscle.

Detailed instructions are provided on the reverse of this leaflet.

Patients with diabetes
If you have diabetes, you should inform your doctor. To prevent low blood sugar levels, your doctor may adjust the dose of your antidiabetic medicines.

• Do not mix Triglyva with other injectable medicines (e.g. insulin).
• Do not use Triglyva in combination with other medicines that are GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Triglyva than you should
If you use more Triglyva than recommended, contact your doctor immediately or go to a hospital. Take the medicine pack with you.
You may require medical treatment. The following symptoms may occur:

• nausea,
• vomiting,
• low blood sugar (hypoglycaemia). Symptoms warning of low blood sugar – see section on side effects under “Common”.

If you forget to use Triglyva

• If less than 12 hours has passed since your scheduled dose of Triglyva, take the medicine as soon as possible.
• However, if more than 12 hours have passed since you should have taken Triglyva, skip the missed dose. Take the next dose the next day as usual.
• Do not take a double dose or increase the dose the next day to make up for a missed dose.

Stopping Triglyva
Do not stop using Triglyva without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Severe allergic reactions (anaphylaxis) have been reported rarely in patients treated with liraglutide.
If symptoms such as difficulty breathing, swelling of the throat and face, or rapid heartbeat occur, seek
medical advice immediately.
Inflammation of the pancreas (pancreatitis) has been reported not infrequently in patients treated with
liraglutide. Pancreatitis may be severe and potentially life-threatening.
You must stop using Triglyva and contact your doctor immediately if any of the following serious
adverse reactions occur:

• severe and persistent abdominal pain (in the stomach area) which may radiate to the back, along with nausea and vomiting, as these may be symptoms of pancreatitis.

Other adverse reactions
Very common: may affect more than 1 in 10 patients

• nausea, vomiting, diarrhoea, constipation, headache – these symptoms usually resolve after a few days or weeks.

Common: may affect up to 1 in 10 patients

• gastrointestinal disorders such as indigestion (dyspepsia), inflammation of the stomach lining, stomach discomfort, upper abdominal pain, heartburn, bloating, flatulence, belching, and dry mouth;
• feeling weak or tired;
• taste disturbances;
• dizziness;
• difficulty sleeping (insomnia); these symptoms usually occur during the first 3 months of treatment;
• gallstones;
• rash;
• injection site reactions (such as bruising, pain, irritation, itching, and rash);
• low blood sugar (hypoglycaemia). Symptoms of low blood sugar may appear suddenly and include cold sweats, cold pale skin, headache, rapid heartbeat, nausea, intense hunger, blurred vision, drowsiness, weakness, nervousness, restlessness, confusion, difficulty concentrating, and tremor. Your doctor will advise you on how to treat symptoms caused by low blood sugar and what to do if such symptoms occur;
• increased activity of pancreatic enzymes such as lipase and amylase.

Uncommon: may affect up to 1 in 100 patients

• fluid loss (dehydration); these symptoms are more likely at the beginning of treatment and may be caused by vomiting, nausea, and diarrhoea;
• delayed gastric emptying;
• inflammation of the gallbladder;
• allergic reactions, including skin rash;
• general malaise;
• increased heart rate.

Rare: may affect up to 1 in 1000 patients

• kidney dysfunction;
• acute kidney failure; symptoms may include reduced urine volume, metallic taste in the mouth, and easy bruising.

Frequency not known: cannot be estimated from the available data

• intestinal obstruction. Severe constipation with additional symptoms such as abdominal pain, bloating, vomiting, etc.
• lumps under the skin may be caused by accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not established).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Triglyva

Keep this medicine out of the sight and reach of children.
Do not use Triglyva after the expiry date stated on the injector label and on the outer packaging
after "Expiry date". The expiry date refers to the last day of the stated month.
Before first use:
Store in a refrigerator (2°C-8°C). Do not freeze.
After first use of the injector:
The injector may be stored for up to one month at a temperature below 30°C or in a refrigerator (2°C-8°C). Do not freeze.
When the injector is not in use, the protective cap should be replaced to protect it from light.
Do not use this 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Triglyva contains

• The active substance is liraglutide. 1 mL of injection solution contains 6 mg of liraglutide. One pre-filled semi-automatic injector contains 18 mg of liraglutide.
• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Triglyva looks like and contents of the pack
Triglyva is supplied as a clear, colourless or almost colourless solution for injection in a pre-filled semi-automatic injector. Each injector contains 3 mL of solution at a concentration of 6 mg/mL and allows administration of doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg.
Triglyva is available in packs containing 3 or 5 pre-filled semi-automatic injectors.
Not all pack sizes may be marketed.
The pack does not contain needles.

Marketing Authorisation Holder and Importer
Cipla Europe N.V.
De Keyserlei 60c, Bus-1301
2018 Antwerp
Belgium
Tel. +32(0)32910101 / +32(0)32910199

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland: Triglyva 6 mg/mL injektioneste, liuos, esitäytetty kynä
Spain: LiraTight 6 mg/mL solución inyectable en pluma precargada
Germany: Liraglutid Cipla 6 mg/mL injektionslösung im Fertigpen
Norway: Triglyva
Poland: Triglyva
Sweden: Triglyva
Italy: LiraTight

Triglyva 6 mg/mL, solution for injection in a pre-filled pen Before using the pen containing Triglyva, carefully read the instructions below. Do not use the pen without prior training by a doctor or nurse. Start by checking that the pen contains Triglyva 6 mg/mL, then review the illustrations below to familiarize yourself with the individual parts of the pen and the needle. Visually impaired or blind individuals who cannot read the dose counter on the pen should not use the pen without assistance. Seek help from a person with good vision who has been trained in using the Triglyva pen. This pen is dose-selectable. It contains 18 mg of liraglutide and allows administration of doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg. The pen is intended for use with single-use NovoFine or BD Ultra-Fine needles up to 8 mm in length and 32 G thickness. Needles are not included in the package. Important information Carefully read this information, as it is essential for the safe use of the pen.
1. Preparing the pen with a new needle Check the name and color of the label on the pen to ensure it contains Triglyva. This is particularly important when using multiple injectable medications. Using the wrong medication may pose a health risk. Remove the pen cap.
Check whether the solution in the pen is clear and colorless. Look through the pen window. Do not use the pen if the solution is cloudy.
Take a new needle and peel off the paper tab.
Ensure the needle is properly attached. Screw the needle directly onto the pen. Tighten until securely fastened.
The needle is protected by two caps. Remove both caps. If the patient does not remove both caps, the solution will not be injected. Remove the outer needle cap and keep it for later use. It will be needed to safely remove the needle from the pen after injection.
Remove the inner needle cap and discard it. Attempting to reattach it may result in accidental needlestick. A drop of solution may appear at the needle tip. This is normal. However, when using the pen for the first time, check the flow of the solution. Do not attach a new needle to the pen until ready to administer the injection. Always use a new needle for each injection. This helps prevent needle blockage, contamination, infection, and inaccurate dosing. Never use a bent or damaged needle.
2. Checking solution flow before using each new pen If the pen is already in use, proceed to point 3 "Setting the dose". Flow should only be checked before the first injection with each new pen. Turn the dose selector knob to the flow check position ( ), just below the 0 mark. Ensure the flow check symbol aligns with the dose indicator.
Hold the pen with the needle pointing upward. Press and hold the injection button until the dose counter returns to 0. The 0 mark must align with the dose indicator. A drop of solution should appear at the needle tip. A small drop may remain at the tip but will not be injected. If no drop appears, repeat step 2 "Checking solution flow before using each new pen" up to 6 times. If still no drop appears, replace the needle and repeat step 2 again. If no drop appears after needle replacement, discard the pen and use a new one. Before first use of a new pen, always ensure a drop of solution appears at the needle tip. This confirms the solution flow is not blocked. If no drop appears, the medication will not be delivered, even if the dose counter moves. This may indicate a blocked or damaged needle. Using a new pen without checking flow before the first injection may result in not receiving the prescribed dose and lack of intended effect of Triglyva.
the prescribed dose and lack of intended effect of Triglyva.
3. Setting the dose Turn the dose selector knob until the dose counter displays the correct dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg). If the wrong dose is selected, turn the knob forward or backward to correct it. The pen allows setting doses up to 3.0 mg. Only the dose counter and dose indicator show how many mg have been selected. The maximum dose per injection is 3.0 mg. If less than 3.0 mg of medication remains in the pen, the dose counter will stop before reaching 3.0. Clicks of the dose selector knob differ when turning forward or backward and when exceeding the remaining mg of medication. Do not count clicks of the pen. Always verify the selected mg of medication using the dose counter and dose indicator before injection. Do not count clicks. Do not use the pen scale. The scale only shows an approximate amount of solution remaining in the pen. Use the dose selector knob only to select doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg. The selected dose must align exactly with the dose indicator to ensure correct dosing.
How much solution remains? The pen scale shows an approximate amount of solution remaining in the pen.
To accurately check how much solution remains, use the dose counter: turn the dose selector knob until the dose counter stops. If 3.0 is visible, at least 3.0 mg of medication remains in the pen. If the dose counter stops before 3.0 mg, the pen does not contain enough solution to deliver a full 3.0 mg dose. If more medication is needed than remains in the pen, the dose may only be divided between the current and a new pen if trained by a doctor or nurse or given specific instructions. Use a calculator to determine doses according to instructions from the doctor or nurse. Perform calculations very carefully. If unsure how to divide the dose between two pens, select and inject the required dose using a new pen.
4. Injecting the dose Insert the needle under the skin as instructed by your doctor or nurse. Ensure the dose counter is visible. Do not cover it with fingers, as this may interrupt the injection.
Press and hold the injection button. Observe the dose counter returning to 0. The 0 mark must align with the dose indicator. You may hear or feel a click. Keep holding the injection button pressed while the needle is in the skin.
While holding the injection button pressed, slowly count to 6. If the needle is removed earlier, solution may leak from the tip. This indicates the full dose was not delivered.
Remove the needle from the skin, then release the injection button. If bleeding occurs at the injection site, gently press on it. A drop of solution may appear at the needle tip after injection. This is normal and does not affect the delivered dose. Always observe the dose counter to monitor the number of mg delivered. Hold the injection button pressed until the dose counter shows 0. How to check if the needle is blocked or damaged? If after holding the injection button the dose counter does not return to 0,
the needle may be blocked or damaged. This means the medication was not delivered at all, even if the dose counter moved and shows a different dose than initially set. What to do if the needle is blocked? Replace the needle as described in point 5 "After injection" and repeat all steps starting from point 1 "Preparing the pen with a new needle". Ensure the full required dose is selected. Do not touch the dose counter during injection, as this may interrupt the injection.
5. After injection Always remove the needle after each injection to ensure comfortable injections and prevent needle blockage. A blocked needle prevents medication delivery. Place the needle tip into the outer needle cap on a flat surface, without touching the needle or the outer cap.
After inserting, carefully push the outer needle cap fully onto the needle. Unscrew the needle and carefully remove it according to instructions from your doctor, nurse, pharmacist, or local authorities.
After each use, replace the pen cap to protect the solution from light. When the pen is empty, dispose of it without a needle attached, according to instructions from your doctor, nurse, pharmacist, or local authorities. Never attempt to reattach the inner cap to the needle. This may result in accidental needlestick.
Always remove the needle from the pen after each injection. This helps prevent needle blockage, contamination, infection, solution leakage, and inaccurate dosing.
Other important information Always keep the pen and needles out of sight and reach of others, especially children. Never share your pen or needles with others. Caregivers must exercise extreme caution when removing and disposing of used needles to eliminate the risk of needlestick injury and cross-infection. Change the injection site daily to reduce the risk of lumps forming.
Caring for the pen Do not leave the pen in a car or any other place where it may be exposed to excessively high or low temperatures. Do not inject Triglyva if it has been frozen. In such cases, the intended effect of the medication may not be achieved. Do not expose the pen to dust, dirt, or liquids. Do not wash, soak, or lubricate the pen. The pen may be cleaned with a cloth dampened with mild detergent. Do not drop the pen or hit it against hard surfaces. If the pen is dropped or suspected of malfunctioning, always screw on a new needle and check solution flow before injection. Do not refill the pen. After emptying, dispose of it. Do not attempt to repair or disassemble the pen.