Somatuline Autogel

Package Leaflet: 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

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 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 affects the secretion of the intestines. It also affects certain advanced types of tumors (called neuroendocrine tumors) in the intestines and pancreas by inhibiting or slowing their growth.

What Somatuline Autogel is used for:

• 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 numbness in the hands and feet;
• for the relief of symptoms such as hot flashes and diarrhea that sometimes occur in patients with neuroendocrine tumors (NETs);
• for the treatment and inhibition of growth of certain advanced tumors in the intestines 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 other medicines in 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 you have diabetes, as lanreotide can cause 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 plan;
• if you have been diagnosed with gallstones, as lanreotide can contribute to the formation of gallstones. In this case, periodic examination is recommended during treatment with Somatuline Autogel. Your doctor may decide to discontinue lanreotide treatment if complications related to gallstone formation occur;
• if you have any thyroid function disorders, as lanreotide may slightly affect the function of this gland;
• 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 caution.

If any of the above points apply to you, consult your doctor or pharmacist before taking Somatuline Autogel.
Consult your doctor or pharmacist if, during treatment:

• you experience fatty stools, loose stools, abdominal bloating, or weight loss, as 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 can affect the action of 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.
Be particularly cautious when using the following medicines:

• cyclosporine(a medicine that reduces the immune system response and is used, for example, after transplantation or in the case of autoimmune disease);
• antidiabetic medicines(e.g., insulin, glitazones, repaglinide, sulfonylurea derivatives);
• 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 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.

Driving and using machines

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

3. How to use Somatuline Autogel

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Treatment of acromegaly
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 strengths of Somatuline Autogel (60 mg, 90 mg, 120 mg).
If a satisfactory response is achieved, your doctor may recommend changing the frequency of Somatuline Autogel 120 mg injections to every 42 or 56 days.
Your doctor will decide on the duration of treatment.
Relief 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 strengths of Somatuline Autogel (60 mg, 90 mg, or 120 mg).
If a satisfactory response is achieved, your doctor may recommend changing the frequency of Somatuline Autogel 120 mg injections to every 42 or 56 days.
Your doctor will decide on the duration of treatment.
Treatment of advanced tumors in the intestines 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, 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 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 ready-to-use pre-filled syringe with an integrated needle and an 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 integrity of the packaging 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 perforated line and remove the pre-filled syringe. The contents of the pre-filled syringe are a viscous, supersaturated solution resembling a thick gel with a white to light yellow color. The supersaturated 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 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 (Figure 5b)

Or

• Change the injection siteeach time, injecting alternately on the 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. or Self-administration or administration by a healthcare professional or a trained person Administration by a healthcare professional or a trained person

• 8. Pull off the needle shield 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 perpendicularlyinto 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. Make sure to push the plunger to inject the full doseand ensure that no medicine remains in the pre-filled 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 retract automatically into the shield.

• 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 more Somatuline Autogel than recommended

If you have injected Somatuline Autogel more frequently than recommended, inform your doctor.
If you have injected more 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 consulting 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. 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, Somatuline Autogel 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 levels. These side effects are common, may occur in 1 in 10 people.

Contact your doctor immediately if you notice:

• redness or swelling of the face, rash, or hives;
• chest tightness, shortness of breath, or wheezing;
• weakness, 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 you experience any of the following side effects, contact your doctor or pharmacist.
The most common side effects expected with Somatuline Autogel include:
gastrointestinal disorders, gallbladder disorders, and injection site reactions. 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, and itching may occur.

Very common: may occur in more than 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
• injection site reactions such as pain, skin thickening, or itching
• abnormal liver and pancreas function test results and changes in blood sugar levels
• nausea, vomiting, constipation, gas, bloating, or abdominal discomfort, indigestion
• dilation 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.

Common: may occur in 1 in 10 people

• hot flashes
• difficulty sleeping
• change in stool color
• changes in sodium and alkaline phosphatase levels shown in blood tests.

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 abdominal pain - may be a symptom of pancreatitis
• injection site reactions: redness, pain, warmth, swelling, feeling of fluid accumulation when pressed, fever - may be symptoms of an abscess
• sudden, severe pain in the upper right or middle abdomen, radiating to the arm or back, abdominal tenderness, nausea, vomiting, and high fever - may be symptoms of cholecystitis
• abdominal pain, fever, chills, jaundice (yellowing of the skin and eyes), nausea, vomiting, clay-colored stools, dark urine, fatigue - may be symptoms of bile duct inflammation
• reduced activity of pancreatic enzymes. Since lanreotide may affect the secretion of pancreatic enzymes involved in food digestion, you may experience symptoms such as fatty stools, loose stools, abdominal bloating, or weight loss.

As lanreotide can cause 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 at specified time intervals.
Inform your doctor or pharmacist about all side effects, including those listed in this package leaflet.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform 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 expiration date stated on the label and carton after "EXP". The expiration date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C). Store in the original package 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 use and storage.
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 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 solution for injection in a pre-filled syringe with an integrated needle and an automatic safety system. The medicine has a viscous, supersaturated solution resembling a thick gel with a white to light yellow color.
Each ready-to-use pre-filled syringe is packaged in a laminated pouch and a carton.
The pack contains one pre-filled syringe with an integrated needle and an automatic safety system.

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 73 Street
00-801 Warsaw
phone: 022 653 68 00
fax: 022 653 68 22

Date of last revision of the package leaflet: September 2023