Somatulina Autogel 120 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SOMATULINA AUTOGEL 120 mg solution for injection in pre-filled syringe

Lanreotide

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

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

Contents of the leaflet:

1. What SOMATULINA AUTOGEL 120 mg is and what it is used for.

2. What you need to know before using SOMATULINA AUTOGEL 120 mg.

3. How to use SOMATULINA AUTOGEL 120 mg.

4. Possible side effects.

5. How to store SOMATULINA AUTOGEL 120 mg.

6. Contents of the pack and other information

1. What SOMATULINA AUTOGEL 120 mg is and what it is used for

The name of the medicine is SOMATULINA AUTOGEL 120 mg.

It is a prolonged-release formulation of lanreotide. It is an injectable solution for exclusive subcutaneous administration. This supersaturated solution is packaged in a pre-filled syringe ready for use.

The active substance, lanreotide, belongs to a group of medicines known as “growth hormone inhibitors”. It is similar to another substance (a hormone) called “somatostatin”.

Lanreotide reduces levels of hormones in the body, such as growth hormone (GH) and insulin-like growth factor-1 (IGF-1), and inhibits the release of certain 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 delaying their growth in advanced stages.

What SOMATULINA AUTOGEL 120 mg is used for:

• Treatment of acromegaly (a condition in which the body produces too much growth hormone) in patients for whom conventional treatment is inadequate or ineffective.
• 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 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.

2. What you need to know before starting to use SOMATULINA AUTOGEL 120 mg

Do not use SOMATULINA AUTOGEL:

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

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• If you are diabetic, as 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), as 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, as lanreotide may slightly reduce thyroid function.

• If you have cardiac disorders, as treatment with lanreotide may cause sinus bradycardia (reduced heart rate). Caution should be exercised when starting lanreotide treatment in patients with bradycardia.

Talk to your doctor or pharmacist if you have any of the conditions listed above before using SOMATULINA AUTOGEL.

Talk to your doctor or pharmacist during treatment:

• If you experience fatty stools, soft stools, abdominal distension, or weight loss, as lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents

The use of SOMATULINA AUTOGEL is not recommended in children and adolescents due to lack of safety and efficacy data.

Other medicines and SOMATULINA AUTOGEL

Some medicines may affect the action of other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Special caution is required when administering lanreotide concomitantly with:

• Cyclosporine (a medicine that reduces immune responses, commonly used after organ transplantation or in autoimmune diseases).
• Bromocriptine (a dopamine agonist used in the treatment of certain types of 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 of these medicines are necessary.

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 use of machines

It is unlikely that treatment with SOMATULINA AUTOGEL will 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 SOMATULINA AUTOGEL 120 mg, injectable solution

Follow exactly the administration instructions given to you 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 SOMATULINA AUTOGEL (60, 90, or 120 mg). Do not stop treatment without your doctor's approval.

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

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

Your doctor will also determine the duration of treatment.

Treatment of intestinal and pancreatic tumours, known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs). It is used when these tumours are advanced and cannot be surgically removed.

The recommended dose is 120 mg every 28 days. Your doctor will determine the duration of treatment with SOMATULINA AUTOGEL for tumour control.

No dose adjustment is required in patients with renal or hepatic impairment or in elderly patients.

Method of administration:

SOMATULINA AUTOGEL must be administered by deep subcutaneous injection.

The injection should be given by a healthcare professional, or by a caregiver (family member or friend), or by yourself after proper training by a healthcare professional.

Your doctor must decide whether you can self-administer the medicine or if it should be administered by another trained person. If you have any doubts at any time about how to administer this injection, contact your doctor or healthcare professional for advice or additional training.

If the injection is administered by a healthcare professional or by a trained person (family member or friend), it should be given in the upper outer quadrant of the buttock or the upper outer thigh (see Figure 5a and 5b below).

If you are self-injecting after adequate training, inject it into the upper outer thigh (see Figure 5b below).

Instructions for use:

Caution: Please read all instructions carefully before starting the injection. The injection is a deep subcutaneous injection and requires a specific technique different from standard subcutaneous injections.

The following instructions explain how to inject SOMATULINA AUTOGEL.

SOMATULINA AUTOGEL is supplied as a ready-to-use pre-filled syringe with a safety system. The needle will automatically retract after complete administration of the product to prevent accidental needle sticks.

1. Remove SOMATULINA AUTOGEL from the refrigerator 30 minutes before administration. Injecting cold medication may be painful. Keep the foil pouch closed until just before injection.

1. Caution: Before opening the pouch, check that it is intact and that the medication has not expired.

Do not use the pre-filled syringe:

• If the pre-filled syringe has been dropped or damaged, or if the pre-filled syringe or pouch appears damaged in any way.
• If the product has expired; the expiry date is printed on the outer carton and on the pouch.

If any of the above apply, contact your doctor or pharmacist.

1. Wash your hands with soap.
2. Tear the foil pouch along the dotted line to open it and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid phase with a gel-like appearance, viscous characteristics, 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.

After opening the foil pouch, the product should be administered immediately.

1. Select an injection site:
   1. If a healthcare professional or a trained family member or friend is administering the injection: use the upper outer quadrant of the buttock or the upper outer thigh.
   2. If you are self-administering the injection: use the upper outer thigh.

or injection by a healthcare professional

• Rotate the injection site between the left and right sides each time you receive a SOMATULINA AUTOGEL injection. Avoid areas with moles, scars, redness, or irregular skin.

1. Clean the injection site.
2. Before injecting, remove the pre-filled syringe from the tray. Discard the tray.

1. Remove the needle cap by pulling it off and discard it.

1. Stretch the skin at the injection site using the thumb and index finger of the hand not holding the pre-filled syringe. Do not puncture the skin. Use a firm, direct motion (like a dart) to rapidly insert the needle perpendicularly (at a 90° angle) to the skin, inserting it fully. It is very important to insert the needle completely. No part of the needle should be visible once fully inserted.

Do not aspirate (do not pull back)

1. Release the stretched skin area. Press the plunger with steady, firm pressure. The medication is denser and harder to push than you might expect. This usually takes about 20 seconds. Inject the entire dose and press once more to ensure the plunger has reached the end.

Note: Maintain pressure on the plunger with your thumb to prevent activation of the automatic safety system.

1. Without releasing pressure on the plunger with your thumb, withdraw the needle from the injection site.

1. Once the needle is withdrawn, stop pressing on the plunger. The needle will automatically retract into the sheath, where it will be permanently enclosed.

1. Apply light pressure to the injection site with a dry cotton ball or sterile gauze to prevent possible bleeding. DO NOT rub or massage the injection site after administration.
2. Dispose of the used syringe according to your doctor's instructions. DO NOT throw the device into household waste.

If you use more SOMATULINA AUTOGEL than you should:

Contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91.562.04.20.

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

If you forget to use SOMATULINA AUTOGEL:

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

If you stop using SOMATULINA AUTOGEL:

Interrupting more than one dose or prematurely stopping treatment with SOMATULINA AUTOGEL may affect the effectiveness of treatment. 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Being more thirsty or more tired than usual, 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 common – 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 wheezing.
• You feel dizzy, possibly as a result of low blood pressure.

These symptoms may be due to an allergic reaction.

The frequency of these side effects is unknown – cannot be estimated from available data.

Other side effects

Tell your doctor or pharmacist if you experience any of the following side effects.

The most common side effects are gastrointestinal disorders, gallbladder problems, and injection site reactions. The side effects that may occur with SOMATULINA AUTOGEL are listed below according to their frequency.

Very common (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, or itchy skin.

Common (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
• Injection site reactions such as pain, hardening of the skin, or itching
• Abnormalities in liver and pancreas blood test results and changes in blood sugar levels
• Nausea, vomiting, constipation, gas, bloated or uncomfortable stomach, indigestion
• Biliary dilation (enlargement of the bile ducts between the liver and gallbladder and the 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 unknown: frequency cannot be estimated from 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 that may feel fluid-filled when pressed, 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 inflammation of the gallbladder (cholecystitis).
• Pain in the upper right abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, fatigue. These may be signs of inflammation of the bile duct (cholangitis).
• Decreased pancreatic enzymes. Since lanreotide can affect the release of pancreatic enzymes involved in food digestion, you may experience symptoms such as fatty stools, soft stools, abdominal bloating, or weight loss.

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.

Tell your doctor or pharmacist if you experience any of the side effects listed above.

Reporting of side effects:

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

5. Storage of SOMATULINE AUTOGEL 120 mg, injectable solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Once removed from the refrigerator, the product, if kept in its sealed pouch, may be returned to the refrigerator (the number of temperature excursions shall not exceed three) for further storage and use, provided that it has been stored for no more than a total of 72 hours at temperatures below 40°C.

Each syringe is individually packaged.

Do not use this medicine if the packaging is damaged or open.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at 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 SOMATULINA AUTOGEL

• The active substance is lanreotide.
• The other components are: water for injections, glacial acetic acid.

Appearance of the product and contents of the pack

SOMATULINA AUTOGEL is a viscous injectable solution in a ready-to-use pre-filled syringe with an automatic safety system. It is a semi-solid formulation, white to pale yellow in colour.

Each pre-filled syringe is packed in a laminated pouch and a cardboard box.

The box contains one 0.5 ml pre-filled syringe with an automatic safety system and attached needle (1.2 mm x 20 mm).

Marketing Authorization Holder and Manufacturer

• Marketing Authorization Holder:

IPSEN PHARMA, S.A.U.

Gran Via de les Corts Catalanes 130-136

08038 Barcelona

Spain

• Manufacturer:

IPSEN PHARMA BIOTECH

Parc d'Activité du Plateau de Signes, C.D. 402,

83870 Signes

France

Date of revision of this leaflet: February 2025

Other sources of information

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