Myrelez

Package leaflet: Information for the user

Myrelez, 60 mg, solution for injection in ampoule-syringe
Myrelez, 90 mg, solution for injection in ampoule-syringe
Myrelez, 120 mg, solution for injection in ampoule-syringe
Lanreotide
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of the leaflet

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

1. What Myrelez is and what it is used for

Myrelez contains the active substance lanreotide, which belongs to a group of medicines called growth hormone inhibitors. It is similar to another substance (hormone) called somatostatin. Lanreotide reduces the activity in the body of hormones such as GH (growth hormone) and insulin-like growth factor (IGF-1), and inhibits the release of certain gastrointestinal hormones and intestinal secretion. It also affects certain advanced types of tumours (called neuroendocrine tumours) occurring in the intestine and pancreas by inhibiting or delaying their growth.

What Myrelez is used for:

• In the treatment of patients with acromegaly (a condition in which the body produces too much growth hormone);
• To relieve symptoms such as flushing and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NET tumours);
• In the treatment and inhibition of growth of certain advanced tumours occurring in the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours (GEP-NET), when they cannot be surgically removed.

2. Important information before using Myrelez

When not to use Myrelez:

• if the patient is allergic (hypersensitive) to lanreotide, somatostatin, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Myrelez, discuss the following with your doctor, pharmacist, or
nurse:

• if the patient has diabetes, because lanreotide may cause fluctuations in blood glucose levels. During treatment with Myrelez, the doctor may recommend regular blood glucose monitoring and may need to adjust the diabetes treatment regimen;
• if the patient has been diagnosed with gallstones, because Myrelez may promote the formation of gallstones. In such cases, periodic monitoring is recommended. If complications related to gallstones occur, the doctor may decide to discontinue treatment with lanreotide;
• if the patient has any thyroid function disorders, because lanreotide may slightly affect thyroid function;
• if the patient has heart function disorders, because sinus bradycardia (slow heart rate) may occur during treatment with Myrelez. Caution should be exercised when initiating Myrelez treatment in patients with bradycardia.

If the patient has any of the conditions listed above, they should discuss them with their doctor or pharmacist before starting treatment with Myrelez.
Children
Myrelez is not recommended for use in children.
Myrelez and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Particular caution is required when using the following medicines concomitantly:

• cyclosporine (an immunosuppressive medicine used, for example, after organ transplantation or in autoimmune diseases);
• bromocriptine (a dopamine receptor agonist used in the treatment of pituitary tumours, Parkinson's disease, or to suppress lactation);
• medicines causing bradycardia (drugs that slow heart rate, e.g. beta-blockers).

The doctor may consider adjusting the dosage of these medicines.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
In such cases, Myrelez will only be used if clearly necessary.
Driving and operating machinery
It is unlikely that Myrelez affects the ability to drive or operate machinery. However, dizziness may occur as an adverse effect during treatment with Myrelez. If such symptoms occur, caution should be exercised when driving or operating machinery.

3. How to use Myrelez

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection administered every 28 days. The dose of medicine used for injection
will be selected by your doctor from among the three available strengths of Myrelez (60, 90, 120 mg).
If the desired response is achieved, your doctor may recommend changing the frequency of administration
of Myrelez 120 mg injections to one injection every 42 or 56 days. Any dose adjustments will depend on the patient's symptoms and response to treatment.
Your doctor will also decide on the duration of treatment.
Relief of symptoms (such as hot flushes and diarrhoea) associated with neuroendocrine tumours
The recommended dose is one injection administered every 28 days. The dose of medicine used for injection
will be selected by your doctor from among the three available strengths of Myrelez (60, 90, 120 mg).
If the desired response is achieved, your doctor may recommend changing the frequency of administration
of Myrelez 120 mg injections to one injection every 42 or 56 days.
Your doctor will also decide on the duration of treatment.
Treatment of advanced gastrointestinal and pancreatic neuroendocrine tumours (GEP-NETs) when
surgical removal is not possible
The recommended dose is 120 mg every 28 days. Your doctor will decide on the duration of treatment with Myrelez for tumour control.
Method of administration
Myrelez should be administered as a deep subcutaneous injection.
If the injection is administered by a healthcare professional or a trained person (a family member or friend),
the injection should be given into the upper outer quadrant of the buttock (see diagrams in section B6 below).
If self-injecting after appropriate training, the injection should be administered into the upper outer part of the thigh (see diagrams in section B6 below).
The decision regarding self-administration or administration by another trained person is made by the doctor. If you have any doubts about the injection technique, contact your doctor or healthcare personnel at any time for advice or further training.
INSTRUCTION FOR USE
Warning: Before starting the injection, carefully read all instructions.
This injection is a deep subcutaneous injection requiring a specific technique, different from standard
subcutaneous injections.
A. Contents of the pack
Below are instructions explaining how to prepare the syringe/needle and how to administer the Myrelez injection.

The contents of the pre-filled syringe consist of a semi-solid gel-like phase with viscous properties and a colour ranging from white to pale yellow. The supersaturated solution may also contain microbubbles, which may disappear during injection. These variations are normal and do not affect the quality of the product.
B. Before starting
B1. Remove Myrelez from the refrigerator 30 minutes before injection. This allows the lanreotide solution to reach room temperature, helping to minimise pain reactions to cold medicine. The laminated pouch should be stored tightly closed and opened only immediately before injection.

30 minutes
B2. Before opening the pouch, check the integrity of the packaging and the expiry date of the medicine. The expiry date is printed on the pouch and the box. – Do not use the medicine after the expiry date or if the pouch is damaged.
B3. Before starting, wash your hands thoroughly with soap and dry them.
B4. Ensure the surface for preparing the injection is clean.
B5. Select the injection site – these sites are shown below
B6. Remember to clean the injection site.

When injecting another person: inject into the upper outer quadrant of the buttock.
When self-injecting: inject into the upper outer part of the thigh.

The injection site for Myrelez should be rotated with each administration, alternating between left and right sides. Avoid areas with moles (birthmarks), scars, red or inflamed skin, or skin with an uneven surface. Remember that once the needle has been inserted, the injection site cannot be changed.
B7. Tear open the pouch and remove the pre-filled syringe

After opening the protective laminated pouch, the product should be administered immediately.
C. Preparing the syringe
C1: Open the needle package.
Hold the needle package and pull off

the cap.
Warning: Do not touch the open end of the needle package. It must remain clean.

C2: Remove the cap from the syringe
Hold the syringe barrel firmly with one hand (not the plunger).
With the other hand, unscrew and remove the cap.
C3: Insert the syringe tip into the open end of the needle package.
Hold the needle package with one hand.

With the other hand, hold the syringe barrel firmly (not the plunger) and screw the syringe onto the needle clockwise until the connection between the syringe and needle is fully locked. While tightening, ensure the needle is aligned with the syringe barrel.
Full locking occurs when further rotation is no longer possible.
Important: Screw the syringe on securely to prevent medicine leakage.

C4: Remove the needle from the package
Hold the syringe barrel (not the plunger).
Remove the needle straight from the package without twisting or rotating it, to ensure the syringe is properly connected to the safety needle.
Warning: From this point, the needle is partially exposed.
NEVER TOUCH OR ATTEMPT TO OPEN THE GREEN NEEDLE SHIELD.
THE GREEN NEEDLE SHIELD IS NOT A REMOVABLE CAP OR NEEDLE COVER.
THE GREEN NEEDLE SHIELD AUTOMATICALLY ACTIVATES DURING NEEDLE INSERTION (INJECTION).
THE GREEN NEEDLE SHIELD WILL AUTOMATICALLY COVER AND LOCK AROUND THE NEEDLE AFTER INJECTION IS COMPLETED.
THE GREEN NEEDLE SHIELD IS A SELF-ACTING SAFETY MECHANISM.

D. Administering the injection
D1: Position the syringe

Injection sites are shown in section B.
Stretch the skin around the injection site with your thumb and index finger to make it taut and flat. Do not pinch the skin.
With the other hand, hold the lower part of the syringe barrel (not the plunger).
Position the syringe at a 90° angle to the skin.
D2: Insert the needle

Without creating a skin fold or compressing the skin at the injection site, firmly press the needle into the skin.
Insert the needle perpendicularly into the skin (at a 90-degree angle) fully into the tissue.
The green needle shield will retract and the safety mechanism will activate.
Continue inserting the needle until only the flange of the green needle shield is visible.
Warning: Maintain this position until the injection is complete. Avoid pulling the needle backward/outward, as this may prematurely activate the safety feature.
At this stage, do not press the plunger. Hold the syringe in this position until the next step.
Warning: During injection, maintain pressure on the needle to prevent activation of the automatic safety system.
D3: Press the syringe plunger
Release the skin that was stretched flat.

Move your hand from the skin to the plunger.
Slowly but steadily, with very firm pressure, continuously press the plunger until its tip touches the syringe barrel (it may be easier to push the plunger with your dominant hand).
The medicine is more viscous and harder to inject than expected.
Inject the full dose and perform the final push to ensure nothing remains to be injected.
This should take approximately 20 seconds.
E. Removing and disposing of the syringe

E1: Remove from the skin
Lift the syringe upward and away from the patient's body.
The green needle shield will cover the needle.
E2: Gently press

Gently press the injection site with a dry cotton swab or sterile gauze to prevent bleeding.
After administering the medicine, do not rub or massage the injection site.

E3: Dispose
Used syringes and needles must be discarded according to local regulations or your doctor's instructions.
Needles are not reusable.
Do not dispose of syringes or needles in household waste bins.
Overdose of Myrelez
If a larger dose of Myrelez has been injected than recommended, inform your doctor immediately.
If a larger dose of Myrelez has been injected than recommended, there is a risk of additional or more severe adverse effects (see section 4. Possible side effects).
Missed dose of Myrelez
As soon as you realise you have missed an injection, contact your doctor for advice on when to schedule the next dose. Do not administer additional injections to make up for a missed dose without discussing it with your doctor.
Stopping Myrelez treatment
Missing more than one dose or stopping Myrelez treatment prematurely may affect the effectiveness of therapy. Please consult your doctor before discontinuing the medicine.
If you have further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse reactions, contact a doctor immediately:

• Increased thirst or fatigue and dry mouth. This may indicate high blood sugar levels or the development of diabetes;
• Feeling hungry, trembling, excessive sweating, or confusion – these may be symptoms of low blood sugar levels. The above adverse reactions are common and may occur in 1 out of 10 people. Contact a doctor immediately if the patient notices:
• Redness or swelling of the face, rash or skin eruptions,
• Chest tightness, shortness of breath, or wheezing,
• Fainting, which may result from low blood pressure. These may be symptoms of an allergic reaction. The frequency of this adverse reaction is unknown; it cannot be estimated based on available data.

Other adverse reactions
If the patient experiences any of the following adverse reactions, contact a doctor or pharmacist immediately.
The most commonly expected adverse reactions during treatment with Myrelez include: gastrointestinal disorders, gallbladder function disorders, and injection site reactions. Below is a list of adverse reactions associated with the use of Myrelez, categorized by frequency of occurrence.

Very common: may occur in more than 1 in 10 treated patients:

• Diarrhea, loose stools, abdominal pain
• Gallstones and gallbladder-related problems. There may be severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, and itching of the skin.

Common: may occur in 1 out of 10 people:

• Weight loss,
• Lack of energy,
• Slow heart rate,
• Feeling of strong fatigue,
• Reduced appetite,
• General weakness,
• Excess fat in the stool,
• Dizziness and headache,
• Hair loss or reduced body hair growth,
• Muscle, ligament, tendon, and bone pain,
• Injection site reactions such as pain or skin hardening,
• Abnormal liver and pancreas function test results and changes in blood sugar levels,
• Nausea, vomiting, constipation, passing gas, bloating, or abdominal discomfort, indigestion,
• Dilation of the bile ducts (enlargement of the bile ducts between the liver, gallbladder, and intestine). There may be abdominal pain, nausea, jaundice, and fever.

Uncommon: may occur in 1 out of 100 people:

• Hot flushes,
• Difficulty falling asleep,
• Change in stool color,
• Changes in blood sodium levels and alkaline phosphatase levels shown in blood tests.

Frequency unknown: frequency cannot be determined from available data:

• Sudden, severe pain in the lower abdomen – this may be a sign of pancreatitis,
• Abscess at the injection site, which may feel fluid-filled when pressed (redness, pain, warmth, and swelling may be associated with fever),
• Inflammation of the gallbladder (cholecystitis) – symptoms may include acute and sudden pain in the upper right or middle part of the abdomen radiating to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever,
• Pain in the upper right part of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue – these may be symptoms of inflammation of the bile ducts (cholangitis).

Since lanreotide causes fluctuations in blood sugar levels, the doctor may recommend regular blood sugar monitoring, especially at the beginning of treatment.
Similarly, due to the possibility of gallbladder disorders during treatment with Myrelez, the doctor may recommend regular monitoring of the gallbladder at the start of treatment and subsequently at regular intervals.
If any of the above adverse reactions occur, inform the doctor or pharmacist.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform the doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 authorization holder.
Reporting adverse reactions helps to gather more information on the safety of using the medicine.

5. How to store Myrelez

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label under
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
After opening the protective aluminum pouch, the medicine should be administered immediately.
Myrelez should be stored in a refrigerator at 2–8°C, in the original packaging,
to protect it from light.
After removal from the refrigerator, if the product has been left in its closed pouch,
it may be returned to the refrigerator (the number of such temperature excursions must not exceed three times)
for continued storage and subsequent use, provided that the product has been stored
at a temperature below 40°C for a total duration not exceeding 72 hours.
Each syringe is individually packaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the Package and Other Information

What Myrelez Contains

• The active substance is lanreotide (in doses of 60 mg, 90 mg or 120 mg).
• Other ingredients: water for injections, glacial acetic acid (to adjust pH).

What Myrelez Looks Like and Contents of the Pack
Myrelez is a viscous injection solution in a semi-transparent plastic syringe with a capacity of 0.5 ml, supplied with a single-use needle safety device. It has a semi-solid consistency and is white to pale yellow in colour.
Each pre-filled syringe is packed in an aluminium pouch and a cardboard box.
Pack sizes:
1 box containing one 0.5 ml syringe with one safety needle (1.2 mm x 20 mm), packed together.
1 multipack containing 3 boxes, each with one 0.5 ml syringe and one safety needle (1.2 mm x 20 mm), packed together.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm Limited
Unit 17
Northwood House
Northwood Crescent
Northwood
Dublin 9
D09 V504
Ireland
e-mail: [email protected]
Amdipharm Limited is part of the ADVANZ PHARMA group.

Manufacturer:
Pharmathen S.A.
Dervenakion 6
Pallini Attiki, 15351
Greece
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

This medicinal product is authorised in the European Economic Area under the following names:
Austria Mytolac 60mg Injektionslösung in einer Fertigspritze
Mytolac 90mg Injektionslösung in einer Fertigspritze
Mytolac 120mg Injektionslösung in einer Fertigspritze
Belgium Mytolac 60mg solution injectable en seringue préremplie
Mytolac 90mg solution injectable en seringue préremplie
Mytolac 120mg solution injectable en seringue préremplie
Czech Republic Mytolente
Denmark Myrelez 60mg injektionsvæske, opløsning i fyldt injektionssprøjte
Myrelez 90mg injektionsvæske, opløsning i fyldt injektionssprøjte
Myrelez 120mg, injektionsvæske, opløsning i fyldt injektionssprøjte
Estonia Myrelez
Finland Myrelez 60mg injektioneste, liuos esitäytetyssä ruiskussa
Myrelez 90mg injektioneste, liuos esitäytetyssä ruiskussa
Myrelez 120mg injektioneste, liuos esitäytetyssä ruiskussa
France Myrelez L.P. 60mg solution injectable à libération prolongée en seringue préremplie
Myrelez L.P. 90mg solution injectable à libération prolongée en seringue préremplie
Myrelez L.P. 120mg solution injectable à libération prolongée en seringue préremplie
Greece Myrelez 60mg ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Myrelez 90mg ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Myrelez 120mg ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Spain Myrelez 60mg Solucion inyectable en jeringa precargada
Myrelez 90mg Solucion inyectable en jeringa precargada
Myrelez 120mg Solucion inyectable en jeringa precargada
Netherlands Mytolac 60mg oplossing voor injectie in een voorgevulde spuit
Mytolac 90mg oplossing voor injectie in een voorgevulde spuit
Mytolac 120mg oplossing voor injectie in een voorgevulde spuit
Ireland Myrelez 60mg solution for injection in a prefilled syringe
Myrelez 90mg solution for injection in a prefilled syringe
Myrelez 120mg solution for injection in a prefilled syringe
Lithuania Myrelez 60mg injekcinis tirpalas užpildytame švirkšte
Myrelez 90mg injekcinis tirpalas užpildytame švirkšte
Myrelez 120mg injekcinis tirpalas užpildytame švirkšte
Latvia Myrelez 60mg šķīdums injekcijām pilnšļircē
Myrelez 90mg šķīdums injekcijām pilnšļircē
Myrelez 120mg šķīdums injekcijām pilnšļircē
Germany Mytolac 60mg Injektionslösung in einer Fertigspritze
Mytolac 90mg Injektionslösung in einer Fertigspritze
Mytolac 120mg Injektionslösung in einer Fertigspritze
Norway Myrelez 60mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Myrelez 90mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Myrelez 120mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Poland Myrelez
Portugal Mytolac 60mg solução injetável em seringa pré-cheia
Mytolac 90mg solução injetável em seringa pré-cheia
Mytolac 120mg solução injetável em seringa pré-cheia
Romania Mytolac 60mg soluţie injectabilă în seringă preumplută
Mytolac 90mg soluţie injectabilă în seringă preumplută
Mytolac 120mg soluţie injectabilă în seringă preumplută
Slovakia Mytolente 60 mg injekčný roztok naplnený v injekčnej striekačke
Mytolente 90 mg injekčný roztok naplnený v injekčnej striekačke
Mytolente 120 mg injekčný roztok naplnený v injekčnej striekačke
Hungary Mytolac 60mg oldatos injekció előretöltött fecskendőben
Mytolac 90mg oldatos injekció előretöltött fecskendőben
Mytolac 120mg oldatos injekció előretöltött fecskendőben
Italy Myrelez