Sandostatin Lar

Leaflet accompanying the packaging: patient information

SANDOSTATIN LAR 10 mg powder and solvent for suspension for injection

SANDOSTATIN LAR 20 mg powder and solvent for suspension for injection

SANDOSTATIN LAR 30 mg powder and solvent for suspension for injection

Octreotide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sandostatin LAR and what is it used for
• 2. Important information before using Sandostatin LAR
• 3. How to use Sandostatin LAR
• 4. Possible side effects
• 5. How to store Sandostatin LAR
• 6. Contents of the packaging and other information

1. What is Sandostatin LAR and what is it used for

Sandostatin LAR is a synthetic derivative of somatostatin, a substance that occurs naturally in the human body, which inhibits the action of certain hormones, such as growth hormone. Sandostatin LAR acts stronger than somatostatin and its action lasts longer.

Sandostatin LAR is used

• in the treatment of acromegaly. Acromegaly is a disease in which the body produces too much growth hormone. In healthy people, growth hormone controls the growth of tissues, organs, and bones. Too much growth hormone causes an increase in the size of bones and tissues, especially hands and feet. Sandostatin LAR significantly alleviates the symptoms of acromegaly, which include headache, excessive sweating, numbness of hands and feet, fatigue, and joint pain. In most cases, excessive production of growth hormone is due to an enlarged pituitary gland (pituitary adenoma); treatment with Sandostatin LAR may reduce the size of the adenoma.

Sandostatin LAR is used in the treatment of patients with acromegaly:

• in whom other types of treatment for acromegaly (surgical treatment or radiotherapy) are not indicated or are ineffective;
• after radiotherapy, during the transitional period, before radiotherapy takes full effect.
• to alleviate symptoms associated with excessive production of certain specific hormones and other substances by the stomach, intestines, and pancreas. Excessive production of hormones and other natural substances can be caused by certain rare diseases of the stomach, intestines, or pancreas. This disrupts the body's natural hormonal balance and is the cause of many symptoms such as facial flushing, diarrhea, low blood pressure, rash, and weight loss. Treatment with Sandostatin LAR helps control these symptoms.
• in the treatment of neuroendocrine tumors located in the intestine (e.g., in the appendix, small intestine, or colon)

Neuroendocrine tumors are rare tumors located in different parts of the body. Sandostatin LAR is also used to inhibit the growth of this type of tumor located in the intestine (e.g., in the appendix, small intestine, or colon).

• in the treatment of pituitary tumors that secrete too much thyroid-stimulating hormone (TSH). Too much TSH leads to hyperthyroidism. Sandostatin LAR is used in patients with pituitary tumors that secrete too much TSH:
• when other types of treatment (surgical treatment or radiotherapy) are not suitable or are ineffective;
• after radiotherapy, during the transitional period, before radiotherapy takes full effect.

2. Important information before using Sandostatin LAR

Follow the doctor's instructions carefully. They may differ from the information contained in this leaflet.

Read the following information before using Sandostatin LAR.

When not to use Sandostatin LAR:

• if the patient is allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Sandostatin LAR, discuss with your doctor:

• if the patient knows they have or have had gallstones in the past or if the patient has any symptoms such as fever, chills, abdominal pain, or yellowing of the skin and eyes; they should tell their doctor, as long-term use of Sandostatin LAR may cause gallstones. The doctor may order periodic gallbladder checks.
• If the patient has diabetes, as Sandostatin LAR may affect blood sugar levels. If the patient has diabetes, their blood sugar levels should be regularly monitored.
• If the patient has had a decreased level of vitamin B12 in the past, the doctor may order periodic checks of vitamin B12 levels.

Examinations and check-ups

If the patient is being treated with Sandostatin LAR for a long time, the doctor may order periodic thyroid function checks.

The doctor will monitor the patient's liver function.

The doctor may order a check of pancreatic enzyme activity.

Children

There is limited experience with the use of Sandostatin LAR in children.

Sandostatin LAR and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

During treatment with Sandostatin LAR, other medicines can usually be continued.

However, it has been reported that Sandostatin LAR affects the action of certain medicines, such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.

If the patient is taking a medicine to control blood pressure (e.g., a beta-adrenergic receptor antagonist or a calcium channel blocker), the doctor may adjust the dosage.

In patients with diabetes, it may be necessary to adjust the insulin dose.

If the patient is to receive lutetium (Lu) oxodotreotide therapy, a radiopharmaceutical treatment, the doctor may interrupt and/or adjust the treatment with Sandostatin LAR for a short period.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Sandostatin LAR may only be used during pregnancy if clearly necessary.

Women of childbearing age should use effective methods of contraception during treatment.

Do not breastfeed while using Sandostatin LAR. It is not known whether Sandostatin LAR passes into breast milk.

Driving and using machines

Sandostatin LAR has no or negligible influence on the ability to drive and use machines.

However, certain side effects that may occur during treatment with Sandostatin LAR, such as headache and fatigue, may reduce the patient's ability to drive and use machines safely.

Sandostatin LAR contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is essentially 'sodium-free'.

3. How to use Sandostatin LAR

Sandostatin LAR should only be administered by deep intramuscular injection into the buttock.

During long-term administration, injections should be performed alternately in the left and right buttock.

Using a higher dose of Sandostatin LAR than recommended:

No life-threatening reactions have been reported after overdose of Sandostatin LAR.

Symptoms of overdose include: hot flashes, frequent urination, fatigue, depression, anxiety, and lack of concentration.

If the patient feels that they have taken too much medicine and experiences the above symptoms, they should tell their doctor immediately.

Missing a dose of Sandostatin LAR:

If an injection is missed, it should be given as soon as possible, and then the treatment should be continued as before.

Administering a dose a few days late is not harmful, but it may cause a temporary recurrence of disease symptoms until the scheduled treatment regimen is resumed.

Stopping treatment with Sandostatin LAR:

After stopping treatment with Sandostatin LAR, disease symptoms may recur.

Therefore, do not stop using Sandostatin LAR without consulting a doctor.

If the patient has any further questions about using this medicine, they should consult their doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Sandostatin LAR can cause side effects, although not everybody gets them.

Some side effects can be serious. The patient should tell their doctor immediately if they experience any of the following symptoms:

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

• Gallstones causing sudden back pain.
• High blood sugar levels.

Common(may affect up to 1 in 10 people):

• Hypothyroidism (underactive thyroid) affecting heart rate, appetite, or weight; fatigue, feeling cold, or swelling of the front of the neck.
• Changes in thyroid function test results.
• Gallbladder inflammation; symptoms may include pain in the right upper abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
• Low blood sugar levels.
• Impaired glucose tolerance.
• Slow heart rate.

Uncommon(may affect up to 1 in 100 people):

• Thirst, low urine output, dark urine, dry, reddened skin.
• Fast heart rate.

Other serious side effects

• Allergic reactions (hypersensitivity), including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling, and tingling, with possible low blood pressure, dizziness, or loss of consciousness.
• Pancreatitis; symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea.
• Hepatitis; symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general feeling of being unwell, itching, pale urine.
• Irregular heartbeat.
• Low platelet count; this may cause increased bleeding or bruising.

If the patient notices any of the above symptoms, they should tell their doctor immediately.

Other side effects:

If the patient notices any of the following side effects, they should tell their doctor, pharmacist, or nurse.

These side effects are usually mild and tend to disappear as treatment progresses.

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

• Diarrhea.
• Abdominal pain.
• Nausea.
• Constipation.
• Bloating with gas.
• Headache.
• Pain at the injection site.

Common(may affect up to 1 in 10 people):

• Discomfort in the stomach after eating (indigestion).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Loose stools.
• Discoloration of stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function test results.
• Hair loss.
• Shortness of breath.
• Weakness.

If the patient experiences any side effects, they should tell their doctor, nurse, or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: 22 49-21-301

Fax: 22 49-21-309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sandostatin LAR

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

Store in the original packaging to protect from light.

Store in a refrigerator (2°C – 8°C). Do not freeze.

On the day of injection, Sandostatin LAR can be stored at a temperature below 25°C.

Do not store Sandostatin LAR after preparation (the prepared suspension must be used immediately).

Do not use this medicine after the expiry date stated on the label and packaging after "EXP" and "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.

Do not use this medicine if foreign particles or a change in color are observed.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Sandostatin LAR contains

• The active substance of Sandostatin LAR is octreotide. One vial contains 10 mg, 20 mg, or 30 mg of octreotide (as octreotide acetate).
• The other ingredients are: in the powder (vial): poly(DL-lactic-co-glycolic acid), mannitol (E 421); in the solvent (ampoule syringe): sodium carmellose, mannitol (E 421), poloxamer 188, water for injections.

What Sandostatin LAR looks like and contents of the pack

A single pack contains one glass vial of 6 ml, closed with a bromobutyl rubber stopper and an aluminum cap with a tear-off seal, containing powder for suspension for injection, and one glass ampoule syringe of 3 ml, protected by two chlorobutyl rubber stoppers (at the front and at the plunger), containing 2 ml of solvent for suspension for injection, packaged together in a sealed blister pack with a vial connector and one safety needle for injection.

Marketing authorization holder

Novartis Poland Sp. z o.o.

Marynarska Street 15

02-674 Warsaw

Phone: +48 22 375 48 88

Manufacturer/Importer

Novartis Poland Sp. z o.o.

Marynarska Street 15

02-674 Warsaw

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

Novartis Pharma NV

Medialaan 40 Bus 1

Vilvoorde, B-1800

Belgium

Novartis Healthcare A/S

Edvard Thomsens Vej 14

Copenhagen S, 2300

Denmark

Novartis Finland Oy

Metsäneidonkuja 10

Espoo, FI-02130

Finland

Novartis Pharma SAS

8-10 rue Henri Sainte-Claire Deville

92500 Rueil Malmaison

France

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

Novartis (HELLAS) SA

12th km National Road Athinon-Lamias

Metamorfosi Attiki, 14451

Greece

Novartis Hungáry Kft.

Vasút u.13.

Budaörs, 2040

Hungary

Novartis Farma S.p.A.

Via Provinciale Schito 131

80058 Torre Annunziata (NA)

Italy

Novartis Farma S.p.A.

Viale Luigi Sturzo 43

• 20154 – Milan (MI) Italy

Novartis Farma - Produtos Farmacêuticos S.A.

Avenida Professor Doutor Cavaco Silva, n.10E, Taguspark

Porto Salvo, 2740-255

Portugal

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma B.V.

Haaksbergweg 16

1101 BX Amsterdam

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sandostatin LAR

Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden

Sandostatine LAR

Belgium, Luxembourg, Netherlands

Sandostatina LAR

Italy, Portugal

Sandostatine L.P.

France

Date of last revision of the leaflet: 10/2024

Information intended for healthcare professionals only:

What dose of Sandostatin LAR to use

Acromegaly

It is recommended to start treatment with Sandostatin LAR at a dose of 20 mg every 4 weeks for 3 months. Patients receiving Sandostatin subcutaneously may start treatment with Sandostatin LAR the day after the last subcutaneous administration of Sandostatin.

Then, the dose should be adjusted based on the level of growth hormone (GH) and insulin-like growth factor 1/somatomedin C (IGF-1) in the blood, as well as clinical symptoms.

In patients who, after 3 months of treatment, have not fully controlled clinical symptoms and biochemical parameters (GH; IGF-1), the dose of Sandostatin LAR may be increased to 30 mg every 4 weeks.

If, after another 3 months of treatment, GH, IGF-1, and/or other symptoms are still not satisfactorily controlled at a dose of 30 mg, the dose of Sandostatin LAR may be increased to 40 mg every 4 weeks.

In patients who have a consistently low level of GH (below 1 microgram/l) and normalized IGF-1 levels in the blood, and in whom the earliest regressing symptoms of acromegaly have receded after 3 months of treatment with a dose of 20 mg, Sandostatin LAR may be administered at a dose of 10 mg every 4 weeks.

However, especially in this group of patients, it is recommended to closely monitor the effectiveness of treatment by measuring GH and IGF-1 levels in the blood and assessing clinical symptoms, both subjective and objective, during treatment with this low dose of Sandostatin LAR.

In patients receiving a fixed dose of Sandostatin LAR, GH and IGF-1 levels should be determined every 6 months.

Hormonally active tumors of the stomach, intestines, and pancreas

• Treatment of patients with symptoms associated with hormonally active neuroendocrine tumors of the stomach, intestines, and pancreasIt is recommended to start treatment with Sandostatin LAR at a dose of 20 mg every 4 weeks. Patients receiving Sandostatin subcutaneously should continue this treatment at the previously effective dose for 2 weeks after the first administration of Sandostatin LAR.

In patients who, after 3 months of treatment, have experienced satisfactory alleviation of symptoms and improvement in biological markers, the dose of Sandostatin LAR may be reduced to 10 mg every 4 weeks.

In patients who, after 3 months of treatment, have only partially alleviated symptoms, the dose of Sandostatin LAR may be increased to 30 mg every 4 weeks.

On days when, despite treatment with Sandostatin LAR, symptoms associated with tumors of the stomach, intestines, and pancreas are exacerbated, it is recommended to administer an additional subcutaneous dose of Sandostatin at the dose used before the introduction of Sandostatin LAR.

This may occur especially during the first 2 months of treatment, before the therapeutic level of octreotide is reached.

• Treatment of patients with advanced neuroendocrine tumors originating from the midgut or with an unknown primary site, in whom a primary site not originating from the midgut has been ruled outThe recommended dose of Sandostatin LAR is 30 mg, administered every 4 weeks. Treatment with Sandostatin LAR to inhibit tumor growth should be continued in the absence of tumor progression.

Treatment of TSH-secreting pituitary adenomas

Treatment with Sandostatin LAR should be started at a dose of 20 mg every 4 weeks and continued for 3 months before possible dose adjustment.

Then, the dose may be adjusted based on TSH and thyroid hormone secretion.

Instructions for preparation and deep intramuscular injection of Sandostatin LAR

ONLY FOR DEEP INTRAMUSCULAR INJECTION

Kit:

a

One vial containing Sandostatin LAR powder

b

One ampoule syringe containing solvent for suspension for injection

c

One vial connector for reconstituting the medicinal product

d

One safety needle for injection

Follow the instructions below to properly reconstitute Sandostatin LAR before administering a deep intramuscular injection.

For the proper reconstitution of Sandostatin LAR, 3 points are critical.

Failure to comply with these may result in improper administration of the medicine.

• The injection set must reach room temperature.Remove the injection set from the refrigerator and let it stand at room temperature for at least 30 minutes before reconstituting the medicinal product, but no longer than 24 hours.
• After adding the solvent, let the vial stand for 5 minutes to ensure complete saturation of the powder with the solvent.
• After saturation, shake the vial vigorouslyin a horizontal direction for at least 30 seconds to form a uniform suspension.The suspension of Sandostatin LAR must be prepared immediatelybefore administration.

Sandostatin LAR can only be administered by trained medical personnel.

Step 1

• Remove the Sandostatin LAR injection set from the refrigerator where it was stored.

IMPORTANT: It is crucial to start the reconstitution process only when the injection set has reached room temperature.

Let the injection set stand at room temperature for at least

30 minutes before reconstituting, but no longer than 24 hours.

Note: The injection set can be put back in the refrigerator if needed.

Step 2

• Remove the plastic cover from the vial and wipe the rubber stopper of the vial with an alcohol swab.
• Remove the protective cover from the vial connector package, but do not remove the vial connector from the package.
• Holding the vial connector by the package, place the vial connector on the vial and push it down until it clicks into place.

• Remove the package from the vial connector by lifting it straight up.

Step 3

• Remove the cap from the ampoule syringe containing the solvent and screw the syringe onto the vial connector.
• Slowly push the plunger all the way down to transfer all of the solvent into the vial.

Step 4

IMPORTANT: It is crucial to let the vial stand for

5 minutesto ensure that the powder is completely saturated with the solvent.

Note: If the plunger is pushed back up, this is a normal situation due to slight overpressure in the vial.

5 minutes

• At this stage, prepare the patient for the injection.

Step 5

• After the powder has been fully saturated with the solvent, check that the plunger is pushed all the way down to the end of the syringe. IMPORTANT:Holding the plunger pushed down, gentlyshake the vial in a horizontal direction for at least30 seconds to form a uniform suspension.If some of the powder does not dissolve, repeat the gentleshaking for another 30 seconds.

Step 6

• Prepare the injection site by wiping it with an alcohol swab.
• Invert the syringe with the vial and slowly pull the plunger to draw the entire contents of the vial into the syringe.
• Unscrew the syringe from the vial connector.

Step 7

• Screw the safety needle for injection onto the syringe.
• Gently shake the syringe again to obtain a milky uniform suspension just before administration.
• Remove the protective cover from the needle by pulling it straight up.
• Gently tap the syringe with your fingers to make any visible air bubbles rise, and then expel them from the syringe. Make surethe injection site has not been contaminated.

• The reconstituted Sandostatin LAR is now ready for immediateadministration - proceed to Step 8. Any delay may cause sedimentation.

Step 8

• Sandostatin LAR must be administered by deep intramuscular injection, NEVERintravenously.
• Insert the entire needle into the left or right buttock at a 90° angle to the skin surface.
• Slowly pull the plunger back to ensure that the needle is not in a blood vessel (change the needle position if it is in a blood vessel).
• Push the plunger with steady force until the syringe is empty. Remove the needle from the injection site and activate the needle guard (following the instructions in Step 9).

Step 9

• Activate the needle guard using one of the following 2 methods:
• press the folding part of the guard against a hard surface (Figure A)
• or press the folding part of the guard with your finger (Figure B).
• Proper activation will be confirmed by a distinct click.

• Discard the syringe immediately (into an appropriate sharps disposal container).