Sandostatin lar

Package leaflet: Information for the patient

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
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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Sandostatin LAR is and what it is 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 pack and other information

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

Sandostatin LAR is a synthetic derivative of somatostatin, a substance naturally present in the human body that inhibits the action of certain hormones, such as growth hormone. Sandostatin LAR is more potent than somatostatin and has a longer duration of action.
Sandostatin LAR is used

• in the treatment of acromegaly
  Acromegaly is a disorder in which the body produces excessive amounts of growth hormone. In healthy individuals, growth hormone regulates the growth of tissues, organs, and bones. Excess growth hormone causes enlargement of bones and tissues, especially in the hands and feet. Sandostatin LAR significantly reduces the symptoms of acromegaly, such as headache, excessive sweating, numbness in the hands and feet, fatigue, and joint pain. In most cases, excessive production of growth hormone is caused by enlargement of the 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 treatments for acromegaly (surgical treatment or radiotherapy) are contraindicated or ineffective;

• following radiotherapy, during the interim period before the full effect of radiotherapy is achieved.

• to relieve 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 may be caused by certain rare diseases of the stomach, intestines, or pancreas. This disrupts the body's natural hormonal balance and leads to various 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 tumours located in the intestine (e.g. in the appendix,
  small intestine, or colon)
  Neuroendocrine tumours are rare tumours occurring in various parts of the body. Sandostatin LAR is also used to inhibit the growth of such tumours located in the intestine (e.g. in the appendix, small intestine, or colon).

• in the treatment of pituitary tumours secreting excessive amounts of thyroid-stimulating hormone (TSH)
  Excessive amounts of thyroid-stimulating hormone (TSH) lead to hyperthyroidism. Sandostatin LAR is used in patients with pituitary tumours secreting excessive amounts of thyroid-stimulating hormone (TSH):

• when other treatments (surgical treatment or radiotherapy) are inappropriate or ineffective;

• after radiotherapy, during the interim period before radiotherapy achieves full effectiveness.

2. Important information before using Sandostatin LAR

Follow all your doctor's recommendations. They may differ from the information
contained in this leaflet.
Please 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 the following with your doctor:

• if the patient has or has previously had gallstones, or if the patient experiences any symptoms such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform the doctor, as long-term use of Sandostatin LAR may lead to the formation of gallstones. The doctor may recommend periodic monitoring of the gallbladder.
• if the patient has diabetes, because Sandostatin LAR may affect blood glucose levels. If the patient has diabetes, blood glucose levels should be monitored regularly.
• if the patient has previously had reduced vitamin B levels, the doctor may recommend periodic monitoring of vitamin B levels.

Tests and follow-up visits
If the patient is receiving long-term treatment with Sandostatin LAR, the doctor may recommend periodic monitoring of thyroid function.
The doctor will monitor the patient's liver function.
The doctor may order tests to assess pancreatic enzyme activity.
Children
Experience with the use of Sandostatin LAR in children is limited.
Sandostatin LAR and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Treatment with Sandostatin LAR generally allows for continued use of other medicines.
However, interactions have been reported between Sandostatin LAR and certain drugs, such as cimetidine,
cyclosporine, bromocriptine, quinidine, and terfenadine.
If the patient is taking medication to control blood pressure (e.g. a beta-blocker or calcium channel blocker), or medication affecting fluid and electrolyte balance, the doctor may adjust the dosage.
In patients with diabetes, the doctor may need to adjust the insulin dose.
If the patient is to receive lutetium oxodotreotide (Lu) therapy, a radiopharmaceutical treatment, the doctor
may temporarily interrupt and/or adjust Sandostatin LAR treatment.
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 before using this medicine.
Sandostatin LAR may be used during pregnancy only if clearly necessary.
Women of childbearing potential should use effective contraception during treatment.
Breastfeeding is not recommended during treatment with Sandostatin LAR. It is unknown whether Sandostatin LAR passes into human breast milk.
Driving and operating machinery
Sandostatin LAR has no effect or a negligible effect on the ability to drive and operate machinery. However, certain adverse reactions associated with Sandostatin LAR, such as headache and fatigue, may reduce the patient's ability to safely drive or operate machinery.
Sandostatin LAR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Sandostatin LAR

Sandostatin LAR must be administered exclusively as an intramuscular injection into the buttock.
During long-term administration, injections should be alternated between the left and right buttock.
Use of a higher than recommended dose of Sandostatin LAR
Life-threatening reactions have not been reported following overdose of Sandostatin LAR.
Symptoms of overdose include: hot flushes, frequent urination, fatigue, depression, anxiety, and lack of concentration.
If you suspect an overdose and the patient experiences the above symptoms, inform the doctor immediately.
Missed dose of Sandostatin LAR
If an injection was not given at the scheduled time, it should be administered as soon as possible, and treatment should then continue as previously planned. Administering the dose several days later is not harmful, but may result in a temporary return of disease symptoms until the planned treatment schedule is resumed.
Stopping Sandostatin LAR treatment
After discontinuation of Sandostatin LAR treatment, disease symptoms may recur. Therefore, do not stop using Sandostatin LAR without consulting your doctor.
If you have any further questions concerning the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. You must immediately inform the doctor if the patient experiences
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 rhythm, appetite, or body weight; fatigue, feeling cold, or swelling in the front of the neck.
• Changes in thyroid function test results.
• Inflammation of the gallbladder; symptoms may include pain in the upper right part of the 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, reduced urine output, dark-coloured urine, dry and red skin.
• Fast heart rate.

Other serious side effects

• Hypersensitivity reactions (allergy), including skin rash.
• A type of allergic reaction (anaphylaxis), which may cause difficulty in swallowing or breathing, swelling and tingling, possibly with low blood pressure, dizziness or loss of consciousness.
• Inflammation of the pancreas; symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea.
• Inflammation of the liver; symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching, pale-coloured urine.
• Irregular heartbeat.
• Low platelet count; this may cause increased bleeding or bruising.

If the patient notices any of the symptoms listed above, they should immediately inform their doctor.
Other side effects:
If the patient notices any of the side effects listed below, they should inform their doctor, pharmacist, or nurse. These side effects are usually mild and tend to resolve as treatment continues.
Very common (may affect more than 1 in 10 people):

• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Bloating with gas release.
• Headache.
• Injection site pain.

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

• Stomach discomfort after meals (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Loose stools.
• Pale-coloured stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function test results.
• Hair loss.
• Shortness of breath.
• Weakness.

If any side effects occur, the patient should inform their doctor, nurse, or pharmacist.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Sandostatin LAR

Keep this 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 administration, Sandostatin LAR may be stored at temperatures 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 following “EXP” and “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Do not use this medicine if foreign particles are observed or if there is a change in colour.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Sandostatin LAR Contains

• The active substance is octreotide. One vial contains 10 mg, 20 mg, or 30 mg of octreotide (as octreotide acetate).
• Other ingredients are:
  in the powder (vial): poly (DL-lactide-co-glycolide), mannitol (E 421).
  in the solvent (pre-filled syringe): sodium carmellose, mannitol (E 421), poloxamer 188,
  water for injections.

What Sandostatin LAR Looks Like and Contents of the Package
The single package contains one 6 ml glass vial stoppered with a bromobutyl rubber closure and an aluminum cap with a tamper-evident seal, containing a powder for suspension for injection, and one 3 ml glass pre-filled syringe protected by two chlorobutyl rubber closures (at the front and at the plunger side), containing 2 ml of solvent for preparing the suspension, all sealed in a blister pack together with a vial connector and one safety injection needle.

Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warszawa
Tel. + 48 22 375 48 88

Manufacturer/Importer
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
Novartis Pharma SAS
8-10 rue Henri Sainte-Claire Deville
92500 Rueil Malmaison
France
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
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 Farmacêutica 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 authorised for marketing in the European Economic Area countries 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

Information intended exclusively for healthcare professionals:
What Dose of Sandostatin LAR Should Be Administered

Acromegaly
Treatment should be initiated with Sandostatin LAR 20 mg administered every 4 weeks for 3 months. Patients previously receiving subcutaneous Sandostatin may start Sandostatin LAR treatment the day after their last subcutaneous dose. The dose should then be adjusted based on serum growth hormone (GH) and insulin-like growth factor-1/somatomedin C (IGF-1) levels, as well as clinical symptoms.

In patients whose clinical symptoms and biochemical parameters (GH; IGF-1) are not fully controlled after 3 months (GH concentrations still greater than 2.5 micrograms/litre), the dose may be increased to 30 mg every 4 weeks. If after an additional 3 months, GH, IGF-1 levels and/or other symptoms are still not adequately controlled while receiving 30 mg, the dose may be increased to 40 mg every 4 weeks.

In patients whose GH levels remain consistently below 1 microgram/litre, serum IGF-1 has normalised, and the most bothersome objective and subjective symptoms of acromegaly have resolved after 3 months of treatment with 20 mg, Sandostatin LAR 10 mg every 4 weeks may be considered. However, particularly in this patient group, close monitoring of treatment efficacy is recommended, including measurement of serum GH and IGF-1 levels and assessment of objective and subjective clinical symptoms during treatment with this lower dose of Sandostatin LAR.

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

Functionally active tumours of the stomach, intestine, and pancreas

• Treatment of patients with symptoms related to functionally active neuroendocrine tumours of the stomach, intestine, and pancreas
  Treatment should be initiated with Sandostatin LAR 20 mg every 4 weeks. Patients previously receiving subcutaneous Sandostatin should continue this treatment at the previously effective dose for 2 weeks after the first injection of Sandostatin LAR.

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

In patients who experience only partial symptom relief after 3 months of treatment, the dose of Sandostatin LAR may be increased to 30 mg every 4 weeks.

On days when symptoms related to tumours of the stomach, intestine, and pancreas remain severe despite treatment with Sandostatin LAR, additional subcutaneous administration of Sandostatin at the dose previously used before initiating Sandostatin LAR is recommended. This may occur particularly during the first 2 months of treatment, before therapeutic octreotide concentrations are achieved.

• Treatment of patients with advanced neuroendocrine tumours originating from the midgut or of unknown primary site, when a primary site outside the midgut has been excluded
  The recommended dose of Sandostatin LAR is 30 mg administered every 4 weeks. Treatment with Sandostatin LAR for tumour growth inhibition should be continued in the absence of tumour progression.

Treatment of TSH-secreting adenomas
Treatment with Sandostatin LAR should be initiated at a dose of 20 mg every 4 weeks and continued for 3 months before any dose adjustment. The dose may then be adjusted according to TSH and thyroid hormone secretion.

Instructions for Reconstitution and Intramuscular Administration of Sandostatin LAR
FOR DEEP INTRAMUSCULAR INJECTION ONLY
Kit Contents:

a One vial containing Sandostatin LAR as a powder
b One pre-filled syringe containing solvent for suspension
c One vial connector for reconstitution of the medicinal product
d One safety injection needle

Follow the instructions below carefully to properly reconstitute Sandostatin LAR before deep intramuscular injection.
Three critical steps are essential for correct reconstitution of Sandostatin LAR.
Failure to follow these instructions may result in improper administration of the drug.

• The injection kit must reach room temperature. Remove the injection kit from the refrigerator and allow it to stand at room temperature for at least 30 minutes, but no longer than 24 hours, before reconstitution.
• After adding the solvent, allow the vial to stand for 5 minutes to ensure complete wetting of the powder by the solution.
• After wetting, shake the vial moderately in a horizontal motion for at least 30 seconds until a uniform suspension is formed. The Sandostatin LAR suspension must be prepared immediately before administration.

Sandostatin LAR must be administered only by trained medical personnel.

Step 1

• Remove the Sandostatin LAR injection kit from the refrigerator where it was stored.
  WARNING: It is crucial to begin the reconstitution process only after the injection kit has reached room temperature. Allow the kit to stand at room temperature for at least 30 minutes before reconstitution, but not longer than 24 hours.
  Note: The injection kit may be returned to the refrigerator if necessary.

Step 2

• Remove the plastic cap from the vial and wipe the rubber stopper with an alcohol swab.
• Remove the protective layer covering the vial connector packaging, but DO NOT remove the vial connector from its packaging.
• Holding the vial connector by its packaging, place it onto the vial and press firmly until it clicks into place with an audible "click".
• Remove the packaging from the vial connector by lifting it vertically upwards.

Step 3

• Remove the cap from the pre-filled syringe containing the solvent and attach the syringe to the vial connector.
• Slowly depress the plunger fully to transfer all of the solvent into the vial.

Step 4

WARNING: It is crucial to allow the vial to stand for 5 minutes to ensure complete wetting of the powder by the solvent.
Note: If the plunger moves back upwards slightly during this time, this is normal and due to slight overpressure in the vial.

• At this stage, prepare the patient for injection.

Step 5

• After the powder has been fully wetted, check that the plunger is fully depressed to the bottom of the syringe.
  WARNING: While keeping the plunger fully depressed, gently shake the vial horizontally for at least 30 seconds to form a uniform suspension (a homogeneous milky suspension). If any powder remains undissolved, repeat gentle shaking for another 30 seconds.

Step 6

• Prepare the injection site by cleaning it with an alcohol swab.
• Turn the syringe with vial upside down and slowly withdraw the entire contents of the vial into the syringe by pulling back the plunger.
• Unscrew the syringe from the vial connector.

Step 7

• Attach the safety injection needle to the syringe.

• Gently shake the syringe again to ensure a uniform milky suspension immediately before administration.

• Remove the protective needle cap with a straight upward motion.

• Gently tap the syringe with fingers to move any visible air bubbles to the top, then expel them from the syringe.

• Check that the injection site has not become contaminated.

• The reconstituted Sandostatin LAR medicinal product is now ready for immediate administration – proceed to Step 8. Any delay may cause precipitation.

Step 8

• Sandostatin LAR must be administered only by deep intramuscular injection. NEVER administer intravenously.
• Insert the entire needle into the left or right gluteal muscle at a 90° angle to the skin surface.
• Slowly pull back the plunger of the syringe to ensure the needle is not in a blood vessel (reposition the needle if it is within a blood vessel).
• Inject steadily by applying constant pressure on the plunger until the syringe is empty. Withdraw the needle from the injection site and activate the needle safety shield (as described in Step 9).

Step 9

• Activate the needle safety shield using one of the following two methods:

  • Press the hinged part of the shield against a hard surface (Figure A)
  • Or press the hinged part of the shield with a finger (Figure B).

• Proper activation will be confirmed by an audible click.

• Immediately dispose of the syringe in an appropriate sharps container.