Somatuline Autogel

Leaflet accompanying the packaging: information for the user

Somatuline AUTOGEL, 60 mg, solution for injection in a pre-filled syringe
Somatuline AUTOGEL, 90 mg, solution for injection in a pre-filled syringe
Somatuline AUTOGEL, 120 mg, solution for injection in a pre-filled syringe
Lanreotide

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

• 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 that has been prescribed for you is called Somatuline Autogel. It contains a substance called lanreotide in a prolonged-release form.
Lanreotide - the active substance - belongs to a group of medicines called growth hormone inhibitors. It is similar to another substance (hormone) called somatostatin.
Lanreotide reduces the activity of hormones such as GH (growth hormone) and IGF-1 in the body, inhibits the release of some gastrointestinal hormones and intestinal secretion. It also has an effect on certain advanced types of tumors (called neuroendocrine tumors) in the gut and pancreas, by inhibiting or slowing their growth.

What Somatuline Autogel is used for:

• in the long-term treatment of patients with acromegaly (a condition in which the body produces too much growth hormone);
• in the treatment of symptoms associated with acromegaly - such as fatigue, headaches, sweating, joint pain, numbness of the feet and hands;
• in alleviating symptoms such as hot flashes and diarrhea, which sometimes occur in patients with neuroendocrine tumors (NETs);
• in the treatment and inhibition of growth of certain advanced tumors in the gut and pancreas, called gastroenteropancreatic neuroendocrine tumors (GEP-NETs) - when they cannot be surgically removed.

2. Important information before using Somatuline Autogel

When not to use Somatuline Autogel

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

Warnings and precautions

Before starting treatment with Somatuline Autogel, you should discuss the following with your doctor:

• if you have diabetes, as lanreotide causes fluctuations in blood sugar levels. During treatment with Somatuline Autogel, your doctor may recommend checking your blood sugar levels and possibly changing your diabetes treatment regimen;
• if you have been diagnosed with gallstones, as lanreotide promotes the formation of stones in the gallbladder. In this case, periodic examination is recommended during treatment with Somatuline Autogel. Your doctor may decide to discontinue treatment with lanreotide if complications arise from gallstone formation;
• if you have any thyroid function disorders, as lanreotide may slightly disrupt the function of this organ;
• if you have heart function disorders, as lanreotide may cause sinus bradycardia (slow heart rate). In patients with bradycardia, Somatuline Autogel should be used with particular caution. If any of the above points apply to you, you should discuss this with your doctor or pharmacist before taking Somatuline Autogel.

Children and adolescents

Somatuline Autogel is not recommended for children and adolescents.

Somatuline Autogel and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Particular caution is required when using the following medicines:

• cyclosporin(a medicine that reduces the immune system's response and is used, for example, after transplantation or in autoimmune diseases);
• bromocriptine(a dopamine receptor agonist used to treat certain types of pituitary tumors and Parkinson's disease or to inhibit lactation);
• medicines that cause bradycardia(medicines that slow down the heart rate, e.g. beta-blockers). Your doctor may consider modifying the dosage of these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine. Somatuline Autogel should only be used if clearly necessary.
Somatuline Autogel should not be used during breastfeeding.

Driving and using machines

It is unlikely that Somatuline Autogel will affect your ability to drive or use machines. However, there is a risk of side effects such as dizziness during treatment with this medicine. If you experience such a side effect, you should not drive or use machines.

3. How to use Somatuline Autogel

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

Treatment of acromegaly and alleviation of acromegaly symptoms
The recommended dose is one injection every 28 days. The dose of Somatuline Autogel used for injection will be chosen by your doctor from the three available doses of Somatuline Autogel (60, 90, 120 mg).
If a satisfactory response is obtained, your doctor may recommend changing the frequency of Somatuline Autogel 120 mg injections to one injection every 42 or 56 days.
Your doctor will decide on the duration of treatment.
Alleviation of symptoms (such as hot flashes and diarrhea) associated with neuroendocrine tumors
The recommended dose is one injection every 28 days. The dose of Somatuline Autogel used for injection will be chosen by your doctor from the three available doses of Somatuline Autogel (60, 90 or 120 mg).
If a satisfactory response to treatment is obtained, your doctor may recommend changing the frequency of Somatuline Autogel 120 mg injections to one injection every 42 or 56 days.
Your doctor will decide on the duration of treatment.
Treatment of advanced tumors in the gut and pancreas, called gastroenteropancreatic neuroendocrine tumors (GEP-NETs), when they 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 inhibit tumor growth.

Method of administration

Somatuline Autogel should be administered by deep subcutaneous injection.
The injection should be performed by a healthcare professional, a trained person (family member or friend), or by the patient themselves after proper training by a healthcare professional.
The decision to self-administer or have someone else administer the injection is made by the doctor. If you have any doubts about the injection technique, you should consult your doctor or healthcare professional for further instructions.
If the injection is performed by a healthcare professional or a trained person (family member or friend), the injection should be given in the upper outer quadrant of the buttock or in the upper outer part of the thigh (see Figures 5a and 5b below).
If the patient is self-administering the injection after proper training, the injection should be given in the upper outer part of the thigh (see Figure 5b below).

Instructions for use

WARNING: Read the entire instructions carefully before performing the injection. Deep subcutaneous injection requires a special technique that differs from standard subcutaneous injection.

The following instructions explain how to perform the Somatuline Autogel injection.
Somatuline Autogel is available in a pre-filled syringe with an integrated needle and a fitted automatic safety system. The needle will retract automatically after completing the injection to prevent accidental needlestick injury.

• 1. RemoveSomatuline Autogel from the refrigerator 30 minutes before injection. Injecting cold contents may be painful. Remove the laminated pouch immediatelybefore use.

• 2. WARNING:Before opening the pouch, check the packaging for integrity and the expiration 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 to be damaged in any way;
• the expiration date of the medicine has passed. The expiration date is printed on the pouch and carton. In both cases, contact your doctor or pharmacist.
• 3. Wash your hands with soap.
• 4. Open the pouch along the perforation and remove the pre-filled syringe. The contents of the pre-filled syringe are a semi-solid substance resembling a thick gel, white to pale yellow in color. The concentrated solution may also contain microbubbles, which may disappear during injection. These differences are normal and do not affect the quality of the product.

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

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

Or

• Change the injection siteeach time, injecting alternately on one side and then the other. 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. Pulling, remove the needle guard and discard it.

• 9. Flattenthe skin at the injection site using your thumb and index finger of the hand not holding the pre-filled syringe. Do not create a foldin the skin. With a firm, smooth motion, insert the entire needle perpendicularlyto the skin surface (at a 90-degree angle). It is important that the entire needle is inserted into the body. After inserting the needle, no part of it should be visible.

Do notwithdrawthe needle.

• 10. Release your thumb and index finger from the skin. Press the plunger with a smooth, firm motion. The contents of the pre-filled syringe are thicker than they appear. Usually, the injection of the contents takes 20 seconds. You should press the plunger so that the full dose is injected and ensure that no medicine remains in the packaging.

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 the pressure on the plunger. The needle will automatically retract into the protective sleeve.

• 13. Gently press the injection site with a dry swab or sterile gauze to prevent bleeding. Do not rub or massagethe injection site.
• 14. Dispose of the used syringe according to the instructions of your doctor or healthcare professional. Do not throw it awayin the trash.

Using a higher dose of Somatuline Autogel than recommended

If you have injected a higher dose of Somatuline Autogel than recommended, you should inform your doctor.
If you have injected a higher dose of Somatuline Autogel than recommended, there is a risk of additional or more severe side effects (see section 4. Possible side effects).

Missing a dose of Somatuline Autogel

If you miss a dose, contact your healthcare professional, who will provide information on when to administer the next dose. Do not administer additional injections 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 prematurely may affect the effectiveness of the therapy. You should consult your doctor before stopping treatment with this medicine.
If you have any further questions about using 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.

If you experience any of the following side effects, contact your doctor immediately:

• increased thirst or fatigue and dry mouth - this may indicate that you have high blood sugar levels or are developing diabetes;
• hunger, trembling, excessive sweating or confusion - these may be symptoms of low blood sugar. The above side effects are common, they may occur in 1 in 10 people.

You should contact your doctor immediately if you notice:

• redness or swelling of the face, rash or hives;
• chest tightness, shortness of breath or wheezing;
• fainting, which may be due to a drop in 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 you experience any of the following side effects, contact your doctor or pharmacist.
The most common side effects expected during treatment with Somatuline Autogel include:
gastrointestinal disorders, gallbladder disorders, and reactions at the injection site. The following side effects are related to the use of Somatuline Autogel, including their frequency.

• diarrhea, loose stools, abdominal pain
• gallstones and gallbladder disorders. Severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and eyes), chills, loss of appetite, itching of the skin. Common: may occur in 1 in 10 people
• weight loss
• lack of energy
• slow heart rate
• severe fatigue
• decreased appetite
• general weakness
• excess fat in the stool
• dizziness and headache
• hair loss or reduced body hair
• muscle, tendon, and bone pain
• reactions at the injection site such as pain or hardening of the skin, itching
• abnormal liver and pancreas function test results and changes in blood sugar levels
• nausea, vomiting, constipation, gas, bloating or discomfort in the abdomen, indigestion
• enlargement of the bile ducts (enlargement of the bile ducts between the liver and the gallbladder and intestine). Abdominal pain, nausea, jaundice, and fever may occur. Uncommon: may occur in 1 in 100 people:
• hot flashes
• difficulty sleeping
• change in stool color
• changes in sodium and alkaline phosphatase levels shown in blood tests. Frequency not known: frequency cannot be estimated from the available data
• sudden, severe pain in the upper abdomen - may be a symptom of pancreatitis
• symptoms at the injection site: redness, pain, warmth, swelling, feeling of fluid when pressed, fever - may be symptoms of an abscess
• sudden, severe pain in the right upper or middle abdomen, radiating to the arm or back, abdominal tenderness, nausea, vomiting, and high fever - may be symptoms of cholecystitis
• pain in the right upper abdomen, fever, chills, yellowing of the skin and eyes (jaundice), nausea, vomiting, clay-colored stools, dark urine, fatigue - may be symptoms of bile duct inflammation. Since lanreotide causes fluctuations in blood sugar levels, your doctor may recommend regular blood sugar checks, especially at the beginning of treatment. Similarly, due to the possibility of gallbladder disorders during treatment with Somatuline Autogel, your doctor may recommend regular gallbladder checks at the beginning of treatment and then at certain time intervals. You should inform your doctor or pharmacist about any side effects of the medicine listed in the leaflet.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
By reporting side effects, you can help 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 after: "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Store in the original packaging to protect from light.
After removal from the refrigerator, the product can be stored in the closed pouch at a temperature below 25°C for a maximum of 24 hours or below 40°C for a maximum of 72 hours in total, but no more than three temperature excursions are allowed, for later storage and use.
Each pre-filled syringe is packaged separately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Somatuline Autogel contains

• The active substance of Somatuline Autogel is lanreotide.
• The other ingredients 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, thick solution for injection in a pre-filled syringe with an integrated needle and a fitted automatic safety system. It has a semi-solid consistency and is white to pale yellow in color.
Each pre-filled syringe is packaged in a laminated pouch and a carton.
The pack contains one pre-filled syringe with a capacity of 0.5 ml.

Marketing authorization holder

Ipsen Pharma
65 Quai Georges Gorse
92100 Boulogne Billancourt
France

Manufacturer

Ipsen Pharma Biotech
Parc d’Activités du Plateau de Signes
Chemin départemental no. 402
83870 Signes, France
To obtain more detailed information, contact the representative of the marketing authorization holder:
Ipsen Poland Sp. z o.o.
Chmielna Street 73
00-801 Warsaw
phone: 022 653 68 00
fax: 022 653 68 22
Date of last revision of the leaflet:July 2022