Somatuline autogel

Package leaflet: Information for the user

Somatuline AUTOGEL, 60 mg, solution for injection in pre-filled syringe
Somatuline AUTOGEL, 90 mg, solution for injection in pre-filled syringe
Somatuline AUTOGEL, 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Somatuline Autogel is and what it is used for

The medicine prescribed for you is called Somatuline Autogel. It contains a substance called lanreotide in a long-acting form.
Lanreotide – the active substance – belongs to a group of medicines known as growth hormone inhibitors. It is similar to another substance (hormone) called somatostatin.
Lanreotide reduces the activity of certain hormones in the body, such as GH (growth hormone) and IGF-1. It also inhibits the release of certain gastrointestinal hormones and intestinal secretion. Additionally, it affects certain advanced types of tumours (called neuroendocrine tumours) located in the intestine and pancreas by inhibiting or delaying their growth.
Somatuline Autogel is used:

• for the long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone);
• for the treatment of symptoms associated with acromegaly, such as fatigue, headaches, sweating, joint pain, and tingling sensations in the feet and hands;
• to relieve symptoms such as diarrhoea and flushing, which sometimes occur in patients with neuroendocrine tumours (NET tumours);
• for the treatment and inhibition of growth of certain advanced tumours located in the intestine and pancreas, known as gastroenteropancreatic neuroendocrine tumours (GEP-NET), when they cannot be surgically removed.

2. Important information before using Somatuline Autogel

When not to use Somatuline Autogel

• if the patient is allergic (hypersensitive) to lanreotide, somatostatin, or any medicines belonging to the same group (somatostatin analogues), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Somatuline Autogel, discuss with your doctor:

• if the patient has diabetes, because lanreotide may cause fluctuations in blood sugar levels. During treatment with Somatuline Autogel, 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 (gallbladder stones), because lanreotide may promote the formation of gallstones. In such cases, periodic monitoring is recommended during treatment with Somatuline Autogel. The doctor may decide to discontinue lanreotide treatment if complications related to gallstone formation occur;
• if the patient has any thyroid function disorders, because lanreotide may slightly affect the function of this organ;
• if the patient has heart function disorders, because sinus bradycardia (slow heart rate) may occur during treatment. Somatuline Autogel should be used with particular caution in patients with bradycardia.

If any of the above conditions apply to the patient, please discuss them with a doctor or pharmacist before taking Somatuline Autogel.
Consult a doctor or pharmacist if, during treatment:

• the patient experiences fatty stools, loose stools, abdominal bloating, or weight loss, because lanreotide may affect the secretion of pancreatic enzymes involved in food digestion.

Children and adolescents
Somatuline Autogel is not recommended for children and adolescents.

Somatuline Autogel and other medicines
Some medicines may affect the action of other medicines. Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particular caution is required when using Somatuline Autogel concomitantly with the following medicines:

• cyclosporine (an immunosuppressive medicine used, for example, after organ transplantation or in autoimmune diseases);
• antidiabetic medicines (e.g. insulin, glitazones, repaglinide, sulfonylurea derivatives);
• bromocriptine (a dopamine receptor agonist used in the treatment of certain types of pituitary tumours, Parkinson's disease, or to suppress lactation);
• medicines causing bradycardia (medicines 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. Somatuline Autogel should only be administered if clearly necessary.

Driving and operating machinery
It is unlikely that Somatuline Autogel will affect the ability to drive or operate machinery. However, during treatment with this medicine, there is a risk of experiencing adverse effects such as dizziness. If such an adverse effect occurs, the patient should not drive or operate machinery.

3. How to use Somatuline Autogel

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Treatment of acromegaly
The recommended dose is one injection every 28 days. The dose of medicine to be injected will be
selected by your doctor from among the three available strengths of Somatuline Autogel (60 mg, 90 mg, 120
mg).
If a desired response is achieved, your doctor may recommend changing the frequency of injections of
Somatuline Autogel 120 mg to one injection every 42 or 56 days.
Your doctor will 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 every 28 days. The dose of medicine to be injected will be
selected by your doctor from among the three available strengths of Somatuline Autogel (60 mg, 90 mg or 120 mg).
If a desired response to treatment is achieved, your doctor may recommend changing the frequency of
injections of Somatuline Autogel 120 mg to one injection every 42 or 56 days.
Your doctor will decide on the duration of treatment.
Treatment of advanced gastrointestinal and pancreatic tumours called 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. Your doctor will decide on the duration of treatment
with Somatuline Autogel to control tumour growth.
Method of administration
Somatuline Autogel must be administered as a deep subcutaneous injection.
The injection should be given by a healthcare professional, by a trained person (a family member or friend), or by the patient themselves after appropriate training by a healthcare professional.
The decision regarding self-administration or administration by another trained person is made by the doctor. If the patient has any doubts about how to administer the injection, they should consult their doctor or healthcare professional for further instructions.
When the injection is administered by a healthcare professional or a trained person (a family member or friend), it should be given into the upper outer quadrant of the buttock or into the upper outer part of the thigh (see Figures 5a and 5b below).
When self-administering the injection after appropriate training, it should be given into the upper outer part of the thigh (see Figure 5b below).
Instructions for use
WARNING: Read all instructions carefully before administering the injection. Deep subcutaneous
injection requires a special technique different from that used for standard subcutaneous injection.
The following instructions explain how to administer a Somatuline Autogel injection.
Somatuline Autogel is supplied in a ready-to-use pre-filled syringe equipped with an automatic needle safety system to prevent needlestick injury after use. The needle retracts automatically after complete injection of the contents to protect the patient from accidental injury.

1. Remove Somatuline Autogel from the refrigerator 30 minutes before administering the injection. Injecting cold medication may be painful. Remove the laminated pouch immediately before use.

2. WARNING: Before opening the pouch, check the integrity of the packaging and the expiry date of the medicine. Do not use the medicine if:
   • the pre-filled syringe is damaged or if the pre-filled syringe or its packaging appears in any way damaged;
   • the expiry date has passed. The expiry date is printed on the pouch and the carton.

In either of the above cases, contact your doctor or pharmacist.

3. Wash your hands with soap.
4. Open the pouch along the dotted line and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid substance resembling a sticky gel, white to pale yellow in colour. The suspension may also contain microbubbles, which may disappear during injection. These variations are normal and do not affect the quality of the product.

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

5. Select the injection site:
   • If the injection is administered by a healthcare professional or another trained person (a family member or friend): upper outer quadrant of the buttock (Fig. 5a) or upper outer part of the thigh (Fig. 5b)
   • If the patient is self-administering: upper outer part of the thigh (Fig. 5b).

Or

• The injection site for Somatuline Autogel must be changed with each administration, alternating between left and right sides. Avoid areas with moles, scars, redness, or skin irregularities. 6. Clean the injection site. 7. Before injection, remove the pre-filled syringe from its tray. Discard the tray.

8. Pull off the needle cap and discard it.

9. Flatten the skin at the injection site using the thumb and index finger of the hand not holding the pre-filled syringe. Do not create a skin fold. With a firm, smooth motion, insert the entire needle perpendicularly into the skin (at a 90º angle). It is important that the entire needle enters the body. After insertion, no part of the needle should be visible. Do not withdraw the needle.

10. Remove thumb and index finger from the skin. Press the plunger with a steady, firm motion. The contents of the pre-filled syringe are thicker than they appear. Injection usually takes about 20 seconds. Push the plunger fully to ensure the complete dose is administered and confirm that no medication remains in the syringe.

WARNING: Do not release pressure on the plunger to prevent activation of the automatic safety
system.

11. Without releasing pressure, withdraw the needle from the injection site.

12. Then release pressure on the plunger. The needle will automatically retract permanently into the needle guard.

13. Gently press a dry cotton swab or sterile gauze pad over the injection site to prevent bleeding. Do not rub or massage the injection site.
14. Dispose of the used syringe according to instructions provided by your doctor or healthcare professional. Do not throw it into household waste.

Use of a higher than recommended dose of Somatuline Autogel
If a dose of Somatuline Autogel has been injected more frequently than recommended, inform your
doctor.
If a larger dose of Somatuline Autogel than recommended has been administered, there is a risk of
additional or more severe adverse effects (see section 4. Possible side effects).
Missed dose of Somatuline Autogel
If a dose has been missed, contact your healthcare professional for advice on when to administer the
next dose. Do not administer additional injections on your own to make up for a missed dose without
discussing it with your doctor.
Stopping treatment with Somatuline Autogel
Missing more than one dose or stopping treatment with Somatuline Autogel earlier than recommended
may affect the effectiveness of therapy. Discuss with your doctor before discontinuing treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, contact a doctor immediately:

• increased thirst or tiredness and dry mouth – this may indicate that the patient has high blood sugar levels or developing diabetes;
• feeling hungry, trembling, excessive sweating or confusion – these may be symptoms of low blood sugar. These side effects are common and may affect up to 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 side effect is unknown; it cannot be estimated based on available data.

Other side effects
If the patient experiences any of the following side effects, contact a doctor or pharmacist.
The most commonly expected side effects during treatment with this medicine include:
gastrointestinal disorders, gallbladder function disorders, and injection site reactions. Below is a list of side effects associated with the use of Somatuline Autogel, classified according to their frequency of occurrence.

Very common: may affect more than 1 in 10 people

• diarrhoea, loose stools, abdominal pain
• gallstones and gallbladder-related problems. These may cause severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itching of the skin.

Common: may affect up to 1 in 10 people

• weight loss
• lack of energy
• slow heart rate
• severe fatigue
• reduced appetite
• general weakness
• excess fat in the stool
• dizziness and headache
• hair loss or reduced body hair
• muscle, ligament, tendon and bone pain
• injection site reactions such as pain, skin hardening or itching
• abnormal liver and pancreas function test results and changes in blood sugar levels
• nausea, vomiting, constipation, flatulence, bloating or abdominal discomfort, indigestion
• dilatation of bile ducts (enlargement of the bile ducts between the liver, gallbladder and intestine). This may cause abdominal pain, nausea, jaundice and fever.

Uncommon: may affect up to 1 in 100 people

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

Frequency not known: frequency cannot be estimated from available data

• sudden, severe lower abdominal pain – may be a sign of pancreatitis
• injection site symptoms: redness, pain, warmth, swelling, fluid-filled feeling upon pressure, fever – may indicate an abscess
• sudden, severe pain in the upper right or middle abdomen radiating to the shoulder or back, abdominal tenderness, nausea, vomiting and high fever – may be symptoms of cholecystitis (gallbladder inflammation)
• pain in the upper right abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, pale-coloured stools, dark urine, fatigue – may be symptoms of cholangitis (bile duct inflammation)
• reduced activity of pancreatic enzymes. Since lanreotide may affect the release of pancreatic enzymes involved in food digestion, the patient may experience symptoms such as fatty stools, loose stools, abdominal bloating or weight loss.

Because lanreotide may cause fluctuations in blood sugar levels, the doctor may recommend regular blood sugar monitoring, especially at the beginning of treatment.
Similarly, due to the potential for gallbladder disorders during treatment with Somatuline Autogel, the doctor may recommend regular gallbladder monitoring, initially at the start of treatment and subsequently at regular intervals.
Inform the doctor or pharmacist about any side effects listed in this leaflet.

Reporting of side effects
If any adverse effects occur, including any unlisted side effects not mentioned in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Somatuline Autogel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following:
"EXP". The expiry date refers to the last day of the stated month. The code "Lot" indicates the batch number.
Store in a refrigerator (2°C – 8°C). Keep in the original packaging to protect from light.
After removal from the refrigerator, if the product has been kept in its sealed pouch, it may be returned to the refrigerator (no more than three such temperature excursions are allowed) for continued storage and subsequent use, provided that it is stored at a temperature below 40°C and for a total duration not exceeding 72 hours.
Each pre-filled 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Somatuline Autogel contains

• The active substance is lanreotide.
• The other components are: water for injections and glacial acetic acid (to adjust pH).

What Somatuline Autogel looks like and contents of the pack
Somatuline Autogel is a ready-to-use injectable solution supplied in a pre-filled syringe with an integrated needle and an automatic safety system. The medicine is a viscous, supersaturated solution that is white to pale yellow in colour.
Each ready-to-use pre-filled syringe is packed in a laminated pouch and a cardboard box.
The pack contains one pre-filled syringe with an integrated needle and an automatic safety system.

Marketing Authorisation Holder
IPSEN PHARMA
70 rue Balard
75015 Paris
France

Manufacturer
Ipsen Pharma Biotech
Parc d’Activités du Plateau de Signes
Chemin départemental no. 402
83870 Signes, France

For further information, please contact the local representative of the Marketing Authorisation Holder:
Ipsen Poland Sp. z o.o.
ul. Chmielna 73
00-801 Warsaw
Tel.: 022 653 68 00
Fax: 022 653 68 22