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 this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 disease 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 alleviates symptoms of acromegaly, such as headache, excessive sweating, numbness in 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 to treat patients with acromegaly:

• in whom other treatments for acromegaly (surgical treatment or radiotherapy) are contraindicated or ineffective;

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

• to relieve symptoms related to 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 causes 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 producing excessive amounts of thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) leads to hyperthyroidism. Sandostatin LAR is used in patients with pituitary tumours producing 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 instructions carefully, as 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 sugar 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 recommend checking pancreatic enzyme activity.

Children

Experience with the use of Sandostatin LAR in children is limited.

Sandostatin LAR and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In general, other medicines may be continued during treatment with Sandostatin LAR.
However, interactions have been reported with 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-blocker or calcium channel blocker), or a medicine 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 treatment with Sandostatin LAR.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 should not be undertaken during treatment with Sandostatin LAR. It is not known whether Sandostatin LAR passes into human breast milk.

Driving and operating machinery

Sandostatin LAR has no effect or negligible effect on the ability to drive and operate machinery. However, certain adverse effects that may occur during treatment with Sandostatin LAR, such as headache and fatigue, may reduce the patient's ability to safely drive and 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 prolonged treatment, injections should be alternated between the left and right buttock.
Use of a higher than recommended dose of Sandostatin LAR
No life-threatening reactions have been reported following overdose of Sandostatin LAR.
Symptoms of overdose include: hot flushes, frequent urination, fatigue, depression, anxiety, and lack of concentration.
If you feel that an overdose has occurred and the patient experiences any of these symptoms, inform your doctor immediately.
Missed dose of Sandostatin LAR
If an injection was not given on time, it should be administered as soon as possible, and treatment should then continue as previously scheduled.
Administering the dose a few days late 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 about the use of this medicine, please consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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):

• Underactive thyroid gland (hypothyroidism) 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 amount of urine passed, 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.
• Pain at the injection site.

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, inform the doctor, nurse, or pharmacist.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform the 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: 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 helps provide more information on the safety of the 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 injection, Sandostatin LAR may 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 following “EXP” and “Expiry date (EXP)”. The expiry date refers to the last day of the specified month.
Do not use this medicine if foreign particles are observed or if there is a change in colour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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).
• The 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 pack
The single pack contains one 6 ml glass vial closed with a bromobutyl rubber stopper and an aluminium seal with a tamper-evident cap, containing a powder for suspension for injection, and one 3 ml glass pre-filled syringe, protected with two chlorobutyl rubber stoppers (at the front and at the plunger end), containing 2 ml of solvent for suspension, together with a vial connector and one safety needle for injection, all sealed in a blister pack.

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 Hungary 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 authorised in the following 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 used

Acromegaly
Treatment should be initiated with Sandostatin LAR at a dose of 20 mg every 4 weeks for 3 months. Patients previously receiving subcutaneous Sandostatin may start Sandostatin LAR treatment the day after the 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 in whom clinical symptoms and biochemical parameters (GH; IGF-1) are not fully controlled after 3 months (GH levels still >2.5 micrograms/l), the dose may be increased to 30 mg every 4 weeks. If after a further 3 months GH, IGF-1 and (or) other symptoms are still not adequately controlled during 30 mg dosing, the dose may be increased to 40 mg every 4 weeks.

In patients with consistently GH levels below 1 microgram/l, normalized serum IGF-1 levels, and with rapid improvement of clinical signs and symptoms of acromegaly after 3 months of treatment with 20 mg, Sandostatin LAR at a dose of 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 clinical symptoms during treatment with this low dose of Sandostatin LAR.

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

Functioning gastroenteropancreatic tumours

• Treatment of patients with symptoms related to functioning neuroendocrine tumours of the stomach, intestine and pancreas
  Treatment should be initiated with Sandostatin LAR at a dose of 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 Sandostatin LAR injection.

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 with 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 are exacerbated despite treatment with Sandostatin LAR, additional subcutaneous Sandostatin at the dose previously used before initiation of Sandostatin LAR is recommended. This may occur particularly during the first 2 months of treatment, before therapeutic octreotide levels are achieved.

• Treatment of patients with advanced neuroendocrine tumours originating from the midgut or of unknown primary origin, in whom a primary tumour outside the midgut has been excluded
  The recommended dose of Sandostatin LAR is 30 mg administered every 4 weeks. Treatment with Sandostatin LAR to inhibit tumour progression 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 preparation and intramuscular administration of Sandostatin LAR

FOR DEEP INTRAMUSCULAR INJECTION ONLY
Kit:

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

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

• 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 direction 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 essential to begin reconstitution 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 no 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.
• Peel off 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.
• Remove the packaging from the vial connector by lifting it vertically upwards.

Step 3

• Remove the cap from the pre-filled syringe containing solvent and screw the syringe onto the vial connector.
• Slowly depress the plunger completely to transfer all the solvent into the vial.

Step 4

WARNING: It is essential 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, 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. WARNING: While holding the plunger fully depressed, shake the vial moderately in a horizontal position for at least 30 seconds to form a uniform milky suspension. If any powder remains undissolved, repeat moderate 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 into the syringe by pulling back the plunger.
• Unscrew the syringe from the vial connector.

Step 7

• Attach the safety needle to the syringe.

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

• Remove the protective needle cap by pulling it straight upwards.

• 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 is not contaminated.

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

Step 8

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

Step 9

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

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

• Successful activation will be confirmed by a distinct click.

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