Myrelez 90 mg solution for injection in pre-filled syringe EFG

Spain
Brand name Myrelez 90 mg solution for injection in pre-filled syringe EFG
Form solution for injection in a pre-filled syringe
Active substance / Dosage
LANREOTIDE ACETATE · 100 mg
Prescription type Hospital Diagnosis
ATC code
H01C H01CB H01CB03
Registration number 86175
Manufacturer Amdipharm Limited

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Myrelez 60mg solution for injection in pre-filled syringe EFG

Myrelez 90mg solution for injection in pre-filled syringe EFG

Myrelez 120mg solution for injection in pre-filled syringe EFG

lanreotide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet as you may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

  1. What Myrelez is and what it is used for
  2. What you need to know before using Myrelez
  3. How to use Myrelez
  4. Possible adverse 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 (a hormone) called somatostatin.

Lanreotide reduces levels of certain hormones in the body, such as growth hormone (GH) and insulin-like growth factor-1 (IGF-1), and inhibits the release of some hormones in the gastrointestinal tract and intestinal secretions. In addition, it has an effect on certain types of tumours (called neuroendocrine tumours) of the intestine and pancreas, by stopping or slowing their growth in advanced stages.

What Myrelez is used for:

  • Treatment of 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 (NETs).
  • Treatment and control of the growth of certain advanced-stage tumours of the intestine and pancreas, known as gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours cannot be surgically removed.

2. What you need to know before starting to use Myrelez

Do not use Myrelez:

  • if you are allergic to lanreotide, somatostatin, or medicines in the same family (somatostatin analogues), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Myrelez:

  • If you have diabetes, because lanreotide may affect your blood sugar levels. Your doctor will monitor your blood sugar levels and may adjust your anti-diabetic treatment while you are receiving lanreotide.
  • If you have gallstones (gallbladder stones), because lanreotide may promote the formation of gallstones in the gallbladder. In this case, you may need periodic monitoring. Your doctor may decide to discontinue treatment with lanreotide if complications related to gallstones occur.
  • If you have thyroid problems, because lanreotide may slightly reduce thyroid function.
  • If you have cardiac disorders, because treatment with lanreotide may cause sinus bradycardia (reduced heart rate). Caution should be exercised when initiating lanreotide treatment in patients with bradycardia.

Speak to your doctor or pharmacist if you have any of the conditions described above before using Myrelez.

Children

The use of Myrelez is not recommended in children.

Other medicines and Myrelez

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You should be especially careful if lanreotide is used together with:

  • Cyclosporine (a medicine that suppresses immune responses; commonly used after organ transplantation or in autoimmune diseases).
  • Bromocriptine (a dopamine agonist used in the treatment of certain brain tumors and Parkinson’s disease, or to suppress lactation after childbirth).
  • Medicines that induce bradycardia (medicines that reduce heart rate, such as beta-blockers).

Your doctor will decide whether dose adjustments are needed for these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Lanreotide should only be administered if clearly necessary.

Driving and using machines

Myrelez treatment is unlikely to affect your ability to drive or operate machinery. However, adverse effects such as dizziness may occur. If you experience such effects, exercise caution when driving or operating machinery.

3. How to use Myrelez

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

Treatment of acromegaly

The recommended dose is one injection every 28 days. Your doctor may adjust the dose of your injection using one of the three available strengths of Myrelez (60, 90, or 120 mg).

If your condition is well controlled with treatment, your doctor may recommend changing the frequency of your Myrelez 120 mg injections to one injection every 42 or 56 days. Any change in dose will depend on your symptoms and how you respond to the medicine.

Your doctor will also decide on the duration of treatment.

Relief of symptoms (such as flushing and diarrhea) associated with neuroendocrine tumours

The recommended dose is one injection every 28 days. Your doctor may adjust the dose of your injection using one of the three available strengths of Myrelez (60, 90, or 120 mg).

If your condition is well controlled with treatment, your doctor may recommend changing the frequency of your Myrelez 120 mg injections to one injection every 42 or 56 days.

Your doctor will also decide on the duration of treatment.

Treatment of tumours of the intestine and pancreas, called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. It is used when these tumours are advanced and cannot be removed by surgery.

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 must be administered by deep subcutaneous injection.

The injection should be given in the upper outer quadrant of the buttock by a healthcare professional or by a caregiver (family member or friend) who has received appropriate training.

If you have been trained to self-administer the injection and choose to do so, the injection should be administered in the outer upper thigh.

The decision on self-administration or administration by another trained person must be made by your doctor.

INSTRUCTIONS FOR USE

  1. Box Contents

The following instructions explain how to inject Myrelez.

Please read all instructions carefully before starting the injection of the product.

Medical diagram showing a needle disposal container with green protective cap and a syringe with separate barrel, cap, and plunger

The contents of the pre-filled syringe are a semi-solid phase with a gelatinous appearance, viscous characteristics, and a color ranging from white to pale yellow. The supersaturated solution may also contain microbubbles, which may clear during injection. These variations are normal and do not interfere with the quality of the product.

  1. Before starting

B1. Remove Myrelez from the refrigerator 30 minutes before administration. Keep the foil pouch sealed until just before injection.

B2. Before opening the pouch, check that it is intact and that the medicine has not expired. The expiration date is printed on the outer carton and on the pouch. Do not use the pre-filled syringe if the product has expired or if the pouch is damaged.

B3. Wash your hands thoroughly with soap and dry them well before beginning.

B4. Make sure you have a clean surface available to prepare the injection.

B5. Choose the injection site: these are shown below.

B6. Be sure to clean the injection site.

B7. Tear the pouch open and remove the pre-filled syringe.

Line drawing showing two hands holding and opening a rectangular container or medication packaging

Schematic diagram of the pelvis and thighs with two gray circles positioned on the hips, delimited by horizontal dashed lines

If a healthcare professional or a trained family member or friend is administering the injection: use the outer upper quadrant of the buttock.

Stylized human body diagram indicating with two gray areas and horizontal dashed lines the drug administration sites on the thighs

If you are administering the injection yourself: use the outer upper part of the thigh.

Alternate the injection site between the left and right side each time you receive a Myrelez injection.

  1. Preparing the syringe

Two hands holding a syringe while the left hand rotates the upper part of the device clockwise following a curved arrow

C1: Remove the syringe cap.

  • With one hand, hold the syringe barrel firmly (do not hold it by the plunger).
  • With the other hand, remove the cap by twisting it off.

Two hands holding and separating a snap-type medical device with a transparent container containing green liquid

C2: Open the needle package

  • Hold the needle package and remove the cap.
  • Caution: Do not touch the open end of the needle package, as it must remain clean.

Two hands rotating a cylindrical part of a medical device to attach or unscrew a component, indicated by a black curved arrow

C3: Insert the syringe tip into the opening of the needle package.

  • Hold the needle package with one hand and,
  • With the other, firmly hold the syringe barrel (not the plunger) and twist until the syringe and needle are fully secured.
  • They are fully secured when you can no longer turn them.

Important: Secure the syringe tightly to prevent medication leakage.

One hand holding a syringe to insert it into a cylindrical container, indicated by a black arrow pointing to the right

Drawing of hands holding a syringe with a red cross over the green protective cap

C4: Remove the needle from the package.

  • Hold the syringe barrel (not the plunger).
  • Remove the needle straight from its package without twisting or turning it to ensure the syringe is properly attached to the safety needle.

Caution: From this point on, the needle is partially exposed.

  • NEVER TOUCH OR ATTEMPT TO REMOVE THE GREEN NEEDLE GUARD
  • THE GREEN NEEDLE GUARD is not a removable cap or cover for the needle.
  • THE GREEN NEEDLE GUARD will automatically activate upon needle insertion.
  • THE GREEN NEEDLE GUARD will automatically cover and lock the needle once the injection is complete.
  • THE GREEN NEEDLE GUARD is an automatic safety locking mechanism.
  1. Administering the injection

Technical drawing showing a hand holding a syringe for an injection

D1: Positioning the syringe

  • To determine the correct injection site, refer to section B.
  • Stretch the skin at the injection site using the thumb and index finger of the hand not holding the pre-filled syringe, making it taut and smooth.
  • With the other hand, hold the lower part of the syringe barrel (not the plunger).
  • Position the syringe at a 90-degree angle to the skin.

Technical drawing showing two hands holding an auto-injector pen to apply it to the skin, with black arrows indicating downward movement

D2: Insert the needle

  • Without pinching or pressing the skin at the injection site, firmly push the needle against the skin.
  • The green needle guard will retract and the safety mechanism will activate.
  • Continue until only the green collar of the needle guard is visible.
  • Do not press the plunger at this step. Keep the syringe in this position for the next step.

Technical drawing showing two hands holding a syringe for an injection

D3: Press the plunger end

  • Move your hand from the skin to the plunger.
  • Press the plunger slowly until its end touches the syringe barrel (it may be easier to press the plunger with your dominant hand).
  • This usually takes about 20 seconds.
  1. Removing and disposing of the syringe

One hand holding a syringe with the needle

E1: Remove from the skin

  • Remove the syringe from the body in a straight line.
  • The green needle guard will cover the needle.

Black line drawing of a hand grasping and pressing a small round object against a curved surface or skin

E2: Apply gentle pressure

  • Apply light pressure at the injection site using a dry cotton ball or sterile gauze to help prevent possible bleeding.
  • Do not rub or massage the injection site after administration.

One hand inserting a needle into a sharps and puncture waste container with a biohazard symbol on a white background

E3: Dispose of the syringe

  • Discard the used syringe and needle according to local regulations or your doctor's instructions.
  • Needles are not reusable.
  • Do not throw needles or syringes into household waste.

If you use more Myrelez than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you have been injected with or administered too much Myrelez, you may experience additional or more severe adverse effects (see section 4, "Possible side effects").

If you forget to use Myrelez

As soon as you realize you have missed an injection, consult your doctor, who will decide when your next injection should be given. Do not self-administer additional injections to make up for missed doses without consulting your healthcare professional.

If you stop using Myrelez

Interrupting treatment for more than one dose or prematurely discontinuing treatment with Myrelez may affect the treatment's effectiveness. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if you notice any of the following adverse effects:

  • Being more thirsty than usual or feeling more tired than normal, and having a dry mouth. These may be signs that you have high blood sugar levels or are developing diabetes.
  • Feeling hungry, trembling, sweating more than usual, or feeling confused. These may be signs of low blood sugar levels.

The frequency of these side effects is frequent; they may affect up to 1 in 10 people.

Tell your doctor immediately if you notice:

  • Your face becomes red or swollen, or you develop spots or a rash.
  • You feel pressure in your chest, have difficulty breathing, or experience wheezing.
  • You feel dizzy, possibly due to a drop in blood pressure.

These symptoms may be due to an allergic reaction.

The frequency of these side effects is unknown; it cannot be estimated from the available data.

Other adverse effects

Immediately inform your doctor or pharmacist if you experience any of the following adverse effects.

The most common adverse effects are gastrointestinal disturbances, gallbladder problems, and injection site reactions. The adverse effects that may occur with Myrelez are listed below, according to their frequency.

Very frequent: may affect more than 1 in 10 people:

  • Diarrhoea, soft stools, abdominal pain
  • Gallstones and other gallbladder abnormalities. You may have symptoms such as sudden, severe abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, and itching of the skin

Frequent: may affect up to 1 in 10 people:

  • Weight loss
  • Lack of energy
  • Slow heart rate
  • Feeling very tired
  • Decreased appetite
  • Feeling weak
  • Excess fat in the stools
  • Dizziness, headache
  • Hair loss or reduced body hair
  • Pain in muscles, ligaments, tendons, and bones
  • Reactions at the injection site, such as pain and hardening of the skin
  • Abnormal liver and pancreas blood test results, and changes in blood sugar levels
  • Nausea, vomiting, constipation, gas, bloated or uncomfortable stomach, indigestion
  • Biliary dilatation (enlargement of the bile ducts between the liver, gallbladder, and intestine). You may have symptoms such as stomach pain, nausea, jaundice, and fever

Uncommon: may affect up to 1 in 100 people:

  • Hot flushes
  • Difficulty sleeping
  • Change in stool colour
  • Changes in blood test results for sodium levels and alkaline phosphatase

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

  • Sudden, severe pain in the lower abdomen. This may be a sign of inflammation of the pancreas (pancreatitis).
  • Redness, pain, warmth, and swelling at the injection site, which may feel fluid-filled when pressed, accompanied by fever. This may be a sign of an abscess.
  • Sudden, severe pain in the upper right or central abdomen, which may spread to the shoulder or back, abdominal tenderness, nausea, vomiting, and high fever. This may be a sign of gallbladder inflammation (cholecystitis).
  • Pain in the upper right part of the abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, pale clay-coloured stools, dark urine, and fatigue. These may be signs of bile duct inflammation (cholangitis).

Since lanreotide may alter your blood sugar levels, your doctor may want to monitor your blood sugar levels, especially at the beginning of treatment.

Similarly, since gallbladder abnormalities may occur with this type of medicine, your doctor may wish to monitor your gallbladder at the start of treatment and periodically thereafter.

Inform your doctor or pharmacist if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 following «EXP». The expiry date refers to the last day of the month indicated.

The product should be administered immediately after opening the protective aluminium pouch.

Store in a refrigerator (between 2 °C and 8 °C) in the original packaging to protect from light.

The product may be returned to the refrigerator for storage and subsequent use (the number of temperature changes should not exceed three), provided it has been kept in the sealed pouch at a maximum temperature of 40 °C for a total of up to 72 hours.

Each syringe is individually packaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Myrelez

  • The active substance is lanreotida (60 mg, 90 mg or 120 mg).
  • The other components are water for injections and glacial acetic acid (for pH adjustment).

Appearance of the product and contents of the pack

Myrelez is a viscous injectable solution contained in a semi-transparent plastic syringe with a volume of 0.5 ml, accompanied by a single-use needle with a safety device. Myrelez is presented as a semisolid formulation of pale yellow colour.

Each pre-filled syringe is packaged in an aluminium pouch and a cardboard box.

Pack containing one 0.5 ml pre-filled syringe and one co-packaged safety needle (1.2 mm × 20 mm).

Multiple pack containing three boxes, each containing one 0.5 ml pre-filled syringe and one co-packaged safety needle (1.2 mm × 20 mm).

Only certain 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

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

Local representative:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7th floor

28046 Madrid (Spain)

Tel. +34 900 834 889

[email protected]

Date of the most recent revision of this leaflet: October 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/