Somatuline Autogel 60 mg solution for injection – patient leaflet, side effects, dosage

1. WHAT LANREOTIDE IPSEN IS AND WHAT IT IS USED FOR What Lanreotide Ipsen is and how it works

Lanreotide, the active substance, belongs to a group of medicines called ‘antigrowth hormones’. It is similar to another substance (a hormone) called ‘somatostatin’.

Lanreotide lowers the levels of 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. Additionally, it has an effect on some advanced type of tumours (called neuroendocrine tumours) of the intestine and pancreas by stopping or delaying their growth.

What Lanreotide Ipsen is used for:

• The treatment of acromegaly (a condition where your body

  produces too much growth hormone)

• The relief of symptoms such as flushing and diarrhoea that

  sometimes occur in patients with neuroendocrine tumours (NETs)

• The treatment and control of the growth of some

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE LANREOTIDE IPSEN

Do not use Lanreotide Ipsen

• If you are allergic (hypersensitive) to lanreotide, somatostatin or

  drugs from the same family (analogues of somatostatin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine:

• If you are diabetic, as Lanreotide Ipsen may affect your blood

  sugar levels. Your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Lanreotide Ipsen

• If you have gallstones, as Lanreotide Ipsen may lead to gallstone

  formation in the gallbladder. In this case, you may need to be monitored periodically. Your doctor may decide to stop treatment with Lanreotide Ipsen if complications arising from gallstones occur.

• If you have any thyroid problems, as Lanreotide Ipsen may

  slightly decrease your thyroid function

• If you have cardiac disorders, as sinus bradycardia (slower heart

  beat) may occur with Lanreotide Ipsen treatment. Special care should be taken when initiating treatment with Lanreotide Ipsen in patients with bradycardia.

If any of the above applies to you, talk to your doctor or pharmacist before using Lanreotide Ipsen.

Talk to your doctor or pharmacist during the treatment:

• If you have fatty stools, loose stools, abdominal bloating

  or weight loss, as lanreotide may affect pancreatic enzymes secretion involved in food digestion.

Children and adolescents

Lanreotide Ipsen is not recommended in children and adolescents.

Other medicines and Lanreotide Ipsen

Some medicines have an effect on the action of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Special care should be taken in case of co-administration with:

• Ciclosporin (a drug reducing immune reactions taken after

  transplantation or in cases of autoimmune disease)

• antidiabetic treatment (for example insulin, glitazones,

  repaglinide, sulfonylureas).

• Bromocriptine (dopamine agonist used in the treatment of

  certain types of tumours of the brain and Parkinson’s disease, or to prevent lactation following childbirth)

• Bradycardia inducing drugs (drugs slowing the heart beat, such

  as beta blockers).

Dose adjustments of such concomitant medication may be considered by your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lanreotide Ipsen should be given to you only if clearly needed.

Driving and using machines

Lanreotide Ipsen is unlikely to affect your ability to drive or use machines, however possible side effects such as dizziness may occur with Lanreotide Ipsen. If you are affected be careful when driving or using machinery.

3. HOW TO USE LANREOTIDE IPSEN

Always use Lanreotide Ipsen exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose

Treatment of acromegaly

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

If you are well controlled on your treatment, your doctor can recommend a change in the frequency of your Lanreotide Ipsen 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 how long you should be treated for.

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

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

Your doctor will also decide how long you should be treated for.

Treatment of advanced tumours of the intestine and pancreas called gastroenteropancreatic neuroendocrine tumours or GEP-NETs. Used when these tumours cannot be removed by surgery.

The recommended dose is 120 mg every 28 days. Your doctor will decide how long you should be treated with Lanreotide Ipsen for tumour control.

Method of administration

Lanreotide Ipsen should be administered by deep subcutaneous injection.

The injection should be given by a healthcare professional (HCP) or a trained person (family member or friend) or yourself after appropriate training from a HCP.

The decision regarding self-administration or administration by another trained person should be taken by your doctor. If you have any doubt on how to administer this injection at any time please contact your doctor or HCP for advice or further training.

If the injection is being given by a healthcare professional or someone else who has been trained (family member or friend), the injection will be given in the upper, outer external quadrant of the buttock or the upper outer thigh (see figures 5a & 5b below).

If you are injecting yourself after appropriate training, the injection should be given in the upper outer thigh (see figure 5b below).

INSTRUCTIONS FOR USE

Attention: Please read all the instructions carefully before starting the injection. The injection is a deep subcutaneous injection that requires a specific technique different to normal subcutaneous injections.

The following instructions explain how to inject Lanreotide Ipsen. Lanreotide Ipsen is supplied in a ready to use pre-filled syringe fitted with an automatic safety system. The needle will retract automatically, following the full administration of the product, to prevent needle stick injury.

Needle cap

Syringe body

Tray Before use

After use (needle guard)

rd)

Before use

1. 1.

   Remove Lanreotide Ipsen from the refrigerator 30 minutes

   prior to administration.

   Injection of cold medication may be painful. Keep the laminated

   pouch sealed until just prior to injection.

2. 2.

   Attention: Before opening the pouch, check that it is intact and

   that the medication has not expired.

   Do not use the pre-filled syringe:

3. •

   If you drop or damage the pre-filled syringe or if the pre-filled

   syringe or pouch appear damaged in any way.

4. •

   If the product has expired; the expiry date is printed on the outer

   carton and the pouch.

   If any of the above apply, you should contact your doctor or

   pharmacist.

5. 3. Wash hands with soap.
6. 4.

   Tear open the pouch along the dotted line and take out the

   pre-filled syringe. The content of the pre-filled syringe is a semi-solid phase having a gel-like appearance, with viscous characteristics and a colour varying from white to pale yellow. The supersaturated solution can also contain micro bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.

   After opening the protective laminated pouch, the product should be administered immediately.

   1. 5. Select an injection site:

If a healthcare professional (HCP) or someone else like a trained family member or friend is doing the injection: use the superior external (upper, outer) quadrant of the buttock (Fig. 5a) or the upper outer thigh (Fig 5b) for injection.

If you are injecting yourself: use the upper outer part of your thigh (Fig 5b).

Injection by HCP or a trained person

Self-injection or injection by HCP or by a trained person

5a or

OK OK OK OK

5b

Alternate the injection site between the right and left side each time you receive an injection of Lanreotide Ipsen. Avoid areas with moles, scar tissue, reddened skin, or skin that feels bumpy.

1. 6. Clean the injection site.
2. 7. Before injecting, remove the pre-filled syringe from its tray. Discard the tray.
3. 8. Remove the needle cap, by pulling off, and discard it. 22 Jul 2024

Ipsen

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Folding Instructions 4 folds - 10 sections

9.0 pt

6.0 pt

Legend

Leaflet

495 x 210 mm

1082357

49.5 x 210 mm

LFL SOMATULINE ATG 60-90-120MG 3.0 UK

04950210P00490210L00-M050U23353

TOP / HAUT

DOWN / BAS

1. 9.

   Flatten injection area using the thumb and index finger of the

   hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a strong, straight dart-like motion to quickly insert the needle perpendicular to the skin (90-degree angle), all the way into the skin. It is very important that you insert the needle completely. You should not see any needle once it is fully inserted.

   Do not aspirate (do not draw back).

   OR

   Injection by HCP or a trained person

   Self-injection or injection by HCP

2. 10.

   Release injection site that has been flattened by your hand. Push

   plunger with steady very firm pressure. The medication is thicker and harder to push than you might expect. Typically 20 seconds are needed. Inject the full dose and give a

   final push to make sure you can not depress it any further.

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

   1. 11.

      Without releasing the pressure on the plunger, withdraw the

      needle from the injection site.

   2. 12.

      Then release the pressure on the plunger. The needle will

      automatically retract into the needle guard where it will be locked permanently.

   3. 13.

      Apply gentle pressure to the injection site with a dry cotton ball

      or sterile gauze to prevent any bleeding.

      Do not rub or massage the injection site after administration.

   4. 14.

      Dispose of the used syringe as instructed by your doctor or

      healthcare provider.

      Do not dispose of the device in your general household rubbish.

If you use more Lanreotide Ipsen than you should

If you have injected more Lanreotide Ipsen than you should, please tell your doctor.

If you have injected or if you are given too much Lanreotide Ipsen you may experience additional or more severe side effects (see section 4 “Possible Side Effects”).

If you forget to use Lanreotide Ipsen

As soon as you realise that you have missed an injection, contact your healthcare professional who will give you advice about the timing of your next injection. Do not self-inject extra injections to make up for a forgotten injection, without discussing with your healthcare professional.

If you stop using Lanreotide Ipsen

An interruption of more than one dose or early termination of the Lanreotide Ipsen treatment can affect the success of the treatment. Please talk to your doctor before you stop the treatment.

If you have any further questions on 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 everybody gets them.

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

• Feeling more thirsty or 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, shaky, sweating more than usual or feeling

  confused. These may be signs of low blood sugar levels.

The frequency of these side effects is common, it may affect up to 1 in 10 people.

Tell your doctor immediately if you notice that:

• Your face becomes flushed or swollen or you develop spots or a

  rash

• Your chest feels tight, you become short of breath or wheezy
• You feel faint, possibly as a result of a drop in blood pressure.

These might be the result of an allergic reaction.

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

Other side effects

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

The most commonly expected side effects are gastrointestinal disorders, gallbladder problems and injection site reactions. The side effects that could occur with Lanreotide Ipsen are listed according to their frequencies below.

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

• Diarrhoea, loose stools, abdominal pain

• Gallstones and other gallbladder problems. You may have

  symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itchy skin.

Common: may affect up to 1 in 10 people:

• Weight loss
• Lack of energy
• Slow heart beat
• Feeling very tired
• Decrease in appetite
• Feeling generally weak
• Excess fat in the stools
• Feeling dizzy, having a headache
• Loss of hair or less development of body hair
• Pain that affects muscles, ligaments, tendons and bones

• Reactions where the injection is given such as pain, hard skin or

  itching

• Abnormal liver and pancreas test results and changes in blood

  sugar levels

  • Nausea, vomiting, constipation, wind, stomach bloating or

    discomfort, indigestion

  • Biliary dilatation (enlargement of the bile ducts between your

    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
• A change in the colour of the stools

• Changes to sodium and alkaline phosphatase levels, shown in

  blood tests.

Not known: frequency cannot be estimated from the available data:

• Sudden, severe pain in your lower stomach. This may be a sign of

  an inflamed pancreas (pancreatitis)

• Redness, pain, warmth and swelling at the site of injection that

  may feel fluid-filled when pressed, fever - this may be a sign of abscess

• Sudden , severe pain in the upper right or centre abdomen

  that may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever – this may be a sign of inflammation of the gallbladder (cholecystitis)

• Pain in the upper right part of your belly (abdomen), fever, chills,

  yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-coloured stools, dark urine, tiredness – these may be signs of inflammation of the bile duct (cholangitis)

• Decrease in pancreatic enzymes. As lanreotide may affect the

  release of pancreatic enzymes involved in food digestion, you may have symptoms such as fatty stools, loose stools, abdominal bloating or weight loss.

Since Lanreotide Ipsen may alter your blood sugar levels, your doctor may want to monitor your blood sugar levels especially at the initiation of the treatment.

Similarly, as gallbladder problems can occur with this type of medicine, your doctor may want to monitor your gallbladder when you start receiving Lanreotide Ipsen, and from time to time afterwards.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LANREOTIDE IPSEN

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

Do not use this medicine after the expiry date which is printed on the carton and labels after <EXP>. The expiry date refers to the last day of that month.

Store Lanreotide Ipsen between 2°C to 8°C in a refrigerator in the original package in order to protect from light.

Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator

(the number of temperature excursions must not exceed three times) for continued storage and later use, provided it has been stored for no longer than a total of 72 hours at below 40°C.

Each syringe is packed individually.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lanreotide Ipsen contains

The active substance is:

lanreotide (60 mg, 90 mg or 120 mg).

The other ingredients are:

Water for injection

Glacial acetic acid (for pH adjustment)

What Lanreotide Ipsen looks like and contents of the pack

Lanreotide Ipsen is a viscous solution for injection in a pre-filled syringe ready to use, fitted with an automatic safety system. It is a white to pale yellow semi-solid formulation.

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

Box of 0.5 ml pre-filled syringe with an automatic safety system with an attached needle (1.2 mm x 20 mm).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ipsen Limited

5^th Floor, The Point

37 North Wharf Road

London W2 1AF

United Kingdom

Manufacturer:

Ipsen Pharma Biotech

Parc d’activités du plateau de Signes

Chemin départemental N°402

83870 Signes

France.

Is this leaflet hard to see or read? Please phone +44 (0) 1753 627777 and ask for help.

This leaflet was last revised in July 2024.