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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• 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 the patient experiences any side effects, including any not listed in this leaflet, please inform the doctor or pharmacist. See section 4.

Table of contents

1. What Somatuline Autogel is and what it is used for
2. Important information 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 the patient is called Somatuline Autogel. It contains a substance called lanreotide in a long-acting formulation.
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. Furthermore, it affects certain advanced types of tumours (called neuroendocrine tumours) occurring in the intestine and pancreas by slowing down or delaying their growth.
Somatuline Autogel is used for the following purposes:

• long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone);
• treatment of symptoms associated with acromegaly, such as fatigue, headaches, sweating, joint pain, and tingling sensations in the feet and hands;
• relief of symptoms such as hot flushes and diarrhoea, which sometimes occur in patients with neuroendocrine tumours (NET tumours);
• treatment and inhibition of growth of certain advanced tumours of the gastrointestinal tract 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 other components of this medicine (listed in section 6), or to other medicines in the same group (somatostatin analogues).

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, because lanreotide may promote gallstone formation. 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 thyroid function;
• 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, discuss them with a doctor or pharmacist before using 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 become pregnant, she should consult her 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 the desired response is achieved, your doctor may decide to change 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.

Symptom relief (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 the desired response to treatment is achieved, your doctor may decide to change 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 neuroendocrine tumours (GEP-NETs)
Somatuline Autogel 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 (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 the injection technique, they should consult their doctor or healthcare professional for further instructions.

If the injection is administered by a healthcare professional or trained person (family member or friend), it should be given into the upper outer quadrant of the buttock or the upper outer part of the thigh (see Fig. 5a and 5b below).
If the patient self-administers the injection after appropriate training, it should be given into the upper outer part of the thigh (see Fig. 5b below).

Instructions for use
WARNING: Read the entire instruction 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 as a ready-to-use pre-filled syringe equipped with an automatic needle safety system that protects against needlestick injury after use. The needle retracts automatically after complete injection of the contents to prevent injury to the patient.

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

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

Or

• The injection site for Somatuline Autogel should be rotated 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 the 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. Insert the entire needle perpendicularly (at a 90º angle) into the skin with a firm, smooth motion. 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 the 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. Continue pressing the plunger until the full dose is injected, ensuring 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 into the protective shield permanently.

13. Gently press a dry 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 from 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 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 Somatuline Autogel
If a dose is missed, contact your healthcare professional for advice on when to administer the next dose. Do not administer additional injections to make up for a missed dose without first discussing it with your doctor.

Stopping treatment with Somatuline Autogel
Missing more than one dose or stopping treatment with Somatuline Autogel prematurely may affect the effectiveness of therapy. 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 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 occur in 1 out of 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 be due to low blood pressure. These may be symptoms of an allergic reaction. The frequency of this side effect is unknown; it cannot be estimated from the 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, categorized by frequency.

Very common: may occur in more than 1 out of 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 occur in 1 out of 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
• dilation 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 occur in 1 out of 100 people

• hot flushes
• difficulty falling asleep
• change in stool colour
• changes in blood levels of sodium 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 pancreatitis
• injection site symptoms: redness, pain, warmth, swelling, fluid-filled sensation upon pressure, fever – these may be signs of abscess
• sudden, severe pain in the upper right or middle abdomen radiating to the shoulder or back, abdominal tenderness, nausea, vomiting and high fever – these may be signs of cholecystitis (inflammation of the gallbladder)
• 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 cholangitis (inflammation of the bile ducts)
• 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 possibility of gallbladder disorders during treatment with Somatuline Autogel, the doctor may recommend regular gallbladder monitoring at the beginning of treatment and then at regular intervals.
Inform the doctor or pharmacist about any side effects listed in this leaflet.

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the 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. "Lot" is 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 kept in its sealed pouch, the product may be returned to the refrigerator (the number of such temperature excursions must not exceed three times) 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 ingredients are: water for injections and glacial acetic acid (for pH adjustment).

What Somatuline Autogel looks like and contents of the pack
Somatuline Autogel is a ready-to-use injectable solution in a pre-filled syringe with an integrated needle and an automatic safety system. The medicine is a viscous, saturated solution, 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 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