Myrelez

Package leaflet: Information for the user

Myrelez, 60 mg, solution for injection in pre-filled syringe
Myrelez, 90 mg, solution for injection in pre-filled syringe
Myrelez, 120 mg, solution for injection in pre-filled syringe
Lanreotide
Please read all of 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 reactions, 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:

• Treatment of patients with acromegaly (a condition in which the body produces too much growth hormone);
• Relief of symptoms such as flushing and diarrhoea that sometimes occur in patients with neuroendocrine tumours (NET tumours);
• 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 this 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 monitoring blood glucose levels 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 impair thyroid function;
• if the patient has cardiac function disorders, because sinus bradycardia (slow heart rate) may occur during treatment with Myrelez. Caution should be exercised when initiating Myrelez in patients with bradycardia.

If the patient has any of the conditions listed above, they should discuss them with a 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, has recently taken, or plans to take.
Special caution is required when using the following medicines concomitantly:

• cyclosporine (an immunosuppressive medicine used, for example, after transplantation or in autoimmune diseases);
• bromocriptine (a dopamine receptor agonist used in the treatment of pituitary tumors, 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 the above-mentioned 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 a doctor or pharmacist before using this medicine.
In these 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, during treatment with Myrelez, adverse effects such as dizziness may occur. If such symptoms occur, caution should be exercised when driving or operating machinery.

3. How to use Myrelez

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
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 the injection
will be selected by the doctor from among the three available strengths of Myrelez (60, 90, 120 mg).
If the desired response is achieved, the 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.
The doctor will also decide on the duration of treatment.
Relief of symptoms (such as hot flashes and diarrhea) associated with
neuroendocrine tumours
The recommended dose is one injection administered every 28 days. The dose of medicine used for the injection
will be selected by the doctor from among the three available strengths of Myrelez (60, 90, 120 mg).
If the desired response is achieved, the doctor may recommend changing the frequency of administration
of Myrelez 120 mg injections to one injection every 42 or 56 days.
The doctor will also decide on the duration of treatment.
Treatment of advanced tumours of the intestine and pancreas, known as
gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The medicine is used when
these tumours cannot be surgically removed
The recommended dose is 120 mg every 28 days. The 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.
When the injection is given by a healthcare professional or a trained person
(a family member or friend), the injection should be administered into the upper, outer quadrant
of the buttock (see diagrams in section B6 below).
When self-administering the injection 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 there are any doubts about the method of injection,
contact your doctor or medical staff at any time for advice or further training.
INSTRUCTIONS FOR USE
Warning: Before starting the injection, carefully read all instructions.
This injection is a deep subcutaneous injection requiring a specific technique,
which differs 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,
ranging in colour 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 administering the injection.
This allows the lanreotide solution to reach room temperature, minimizing pain reaction
to the 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 medicine's expiry date.
The expiry date is printed on the pouch and the carton. – Do not use the medicine after
the expiry date or if the pouch is damaged.
B3. Before starting, wash hands thoroughly with soap and dry them.
B4. Ensure the surface for preparing the injection is clean.
B5. Choose 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 sides.
Avoid areas with moles (birthmarks), scars, red or inflamed skin, or skin with an uneven surface.
Note that once the needle is 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
With one hand, hold the syringe barrel (not the plunger) firmly.
With the other hand, remove the cap by twisting it off.
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 (not the plunger) firmly 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 no further rotation is possible.
Important: Screw the syringe on securely to prevent leakage of the medicine.

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 safe 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 activates automatically during needle insertion (injection).
THE GREEN NEEDLE SHIELD will automatically cover the needle and lock around it
after the injection is complete.
THE GREEN NEEDLE SHIELD is an automatic 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 thumb and index finger
to make it flat and taut. 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 pinching 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 skin.
The green needle shield will retract and the safety mechanism will activate.
Continue inserting the needle until only the collar 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 flattened skin area with your hand.

Move your hand from the skin to the plunger.
Slowly but steadily, applying very firm pressure without interruption, press the plunger
until its tip touches the syringe barrel (it is easier to press the plunger with the dominant hand).
The medicine is more viscous and harder to inject than expected.
The full dose must be injected, including 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 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 disposed of 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 higher dose of Myrelez has been injected than recommended, inform your doctor immediately.
If a higher 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 the patient realizes a dose has been missed, contact their doctor, who will provide information on the timing of the next dose. Do not administer additional injections to make up for a missed dose without discussing it with the doctor.
Stopping Myrelez treatment
Missing more than one dose or stopping Myrelez treatment prematurely may affect treatment efficacy. Discuss with your doctor before discontinuing the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience 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 that the patient has high blood sugar levels or developing diabetes;
• feeling of hunger, trembling, excessive sweating or confusion – these may be symptoms of low blood sugar. The above adverse reactions are common and may occur in 1 in 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 from 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 reactions at the injection site. Below are the adverse reactions associated with the use of Myrelez, classified by frequency of occurrence.
Very common: may occur in more than 1 in 10 treated patients:

• diarrhoea, loose stools, abdominal pain
• gallstones and gallbladder-related problems. 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 may occur.

Common: may occur in 1 in 10 people:

• weight loss,
• lack of energy,
• slow heart rate,
• feeling of extreme fatigue,
• decreased appetite,
• general weakness,
• excess fat in stools,
• dizziness and headache,
• hair loss or reduced body hair growth,
• muscle, ligament, tendon and bone pain,
• reactions at the injection site such as pain or skin hardening,
• abnormal liver and pancreas function test results and changes in blood sugar levels,
• nausea, vomiting, constipation, passing wind, bloating or abdominal discomfort, indigestion,
• dilation of bile ducts (enlargement of the bile ducts between the liver, gallbladder and intestine). Abdominal pain, nausea, jaundice and fever may occur.

Uncommon: may occur in 1 in 100 people:

• hot flushes,
• difficulty falling asleep,
• change in stool colour,
• changes in blood sodium levels and alkaline phosphatase levels shown in blood tests.

Frequency not known: frequency cannot be estimated from available data:

• sudden, severe pain in the lower abdomen – this may be a symptom 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, pale-coloured 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 monitoring of blood sugar, 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 beginning 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 effects occur, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products 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 provide more information on the safety of the medicine.

5. How to store Myrelez

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
After opening the protective aluminium pouch, the medicine should be administered immediately.
Myrelez should be stored in a refrigerator at 2 - 8 °C, in the original packaging, to protect from light.
After removal from the refrigerator, if the product has been kept in a closed pouch, it may be returned to the refrigerator (the number of such temperature excursions must not exceed three times) for continued storage and later 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 will help protect the environment.

6. Contents of the Packaging 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, to which a single-use needle safety device is attached. 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 a 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 Member States of 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