Sandostatin

Leaflet accompanying the packaging: patient information

SANDOSTATIN 50 micrograms/1 ml solution for injection/infusion

SANDOSTATIN 100 micrograms/1 ml solution for injection/infusion

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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Sandostatin and what is it used for

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

Sandostatin is used

• in acromegaly, a disease in which the body produces too much growth hormone. In healthy individuals, growth hormone controls the growth of tissues, organs, and bones. Excessive growth hormone causes an increase in bone and tissue size, especially in the hands and feet. Sandostatin significantly alleviates the symptoms of acromegaly, including headache, excessive sweating, numbness of hands and feet, fatigue, and joint pain.
• to alleviate symptoms caused by certain gastrointestinal tumors(such as carcinoids, VIPomas, glucagonomas, gastrinomas, insulinomas). In these diseases, the stomach, intestines, or pancreas produce an excessive amount of specific hormones and other substances, disrupting the body's natural hormonal balance and causing many symptoms such as facial flushing, diarrhea, low blood pressure, rash, and weight loss. Treatment with Sandostatin helps control these symptoms.
• to prevent complications after pancreatic surgery. Treatment with Sandostatin helps reduce the risk of postoperative complications (such as abdominal abscess, pancreatitis).
• to stop bleeding and prevent recurrent bleeding from esophageal varicesin patients with liver cirrhosis (chronic liver disease). Treatment with Sandostatin helps control bleeding and reduce the need for blood transfusions.
• to treat pituitary tumors that secrete too much thyroid-stimulating hormone (TSH). Excessive TSH leads to hyperthyroidism. Sandostatin is used in patients with pituitary tumors that secrete too much TSH:
• when other types of treatment (surgical or radiation therapy) are not suitable or

ineffective;

• after radiation therapy during the transitional period, until radiation therapy takes full effect.

2. Important information before using Sandostatin

When not to use Sandostatin:

• 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, the patient should discuss with their doctor:

• if the patient knows they have or have had gallstones or if the patient experiences any symptoms such as fever, chills, abdominal pain, or yellowing of the skin and eyes; they should inform their doctor, as long-term use of Sandostatin may cause gallstones. The doctor may order periodic gallbladder checks.
• if the patient has blood sugar problems and has diabetes or hypoglycemia. If Sandostatin is used to treat bleeding from esophageal varices, blood sugar control is necessary.
• if the patient has had a reduced vitamin B12 level in the past, the doctor may recommend periodic vitamin B12 level checks.
• Octreotide may slow the heart rate, and at very high doses, it may cause abnormal heart rhythm. During treatment, the doctor may monitor the patient's heart rate.

Examinations and check-ups

If the patient is being treated with Sandostatin for a long time, the doctor may order periodic checks of thyroid function. The doctor will monitor the patient's liver function. The doctor may order checks of pancreatic enzyme activity.

Children

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

Sandostatin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. During treatment with Sandostatin, the patient can usually continue taking other medicines. However, it has been reported that Sandostatin 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 (such as a beta-adrenergic receptor antagonist or a calcium channel blocker), or a medicine to maintain water 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 interrupt and/or adjust Sandostatin treatment.

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 should only be used during pregnancy if clearly necessary. Women of childbearing age should use effective contraception during treatment. Breastfeeding should not be done while using Sandostatin. It is not known whether Sandostatin passes into breast milk.

Driving and using machines

Sandostatin has no or negligible influence on the ability to drive and use machines. However, certain side effects that may occur during treatment with Sandostatin, such as headache and fatigue, may reduce the patient's ability to drive and use machines safely.

Sandostatin contains sodium

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

3. How to use Sandostatin

This medicine should always be used exactly as the doctor or pharmacist has told the patient. In case of doubt, the patient should consult their doctor or pharmacist. Depending on the disease being treated, Sandostatin may be given:

• by subcutaneous injection or
• by intravenous infusion.

In the case of liver cirrhosis (chronic liver disease), the doctor may adjust the maintenance dose. The doctor or nurse will explain to the patient how to inject Sandostatin under the skin, while intravenous infusion must always be performed by medical personnel.

• Subcutaneous injection

The proper place for subcutaneous injections is the upper part of the arms, thighs, or abdomen. For each subcutaneous injection, a new site should be chosen to avoid tissue irritation. The doctor or nurse will provide detailed instructions on how to administer the medicine to patients who will be self-administering subcutaneous injections. If the medicine is stored in the refrigerator, it is recommended to bring the ampoules to room temperature before administration. This will reduce the risk of pain at the injection site. The ampoule can be warmed in the hands, but it should not be heated. Some patients experience pain at the subcutaneous injection site. This pain is usually short-lived. If pain occurs, it can be alleviated by gently rubbing the injection site for a few seconds after administering the medicine. Before administering the contents of the ampoule with Sandostatin, the patient should check if the solution contains solid particles or has changed color. The medicine should not be administered if changes in the appearance of the solution are observed.

Using a higher dose of Sandostatin than recommended

Symptoms of overdose include: irregular heartbeat, low blood pressure, cardiac arrest, brain hypoxia, severe stomach pain, yellowing of the skin and eyes, nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, abdominal swelling, discomfort, high lactic acid levels in the blood, and abnormal heart rhythm. If the patient feels they have taken too much Sandostatin and experiences the above symptoms, they should immediately inform their doctor.

Missing a dose of Sandostatin

The patient should take one dose of the medicine as soon as they remember, and then continue treatment as before. Missing a dose is not harmful, but it may cause a temporary recurrence of disease symptoms until the planned treatment schedule is resumed. The patient should not inject a double dose to make up for the missed dose.

Stopping treatment with Sandostatin

After stopping treatment with Sandostatin, disease symptoms may recur. Therefore, the patient should not stop using Sandostatin without consulting their doctor. If the patient has any further doubts about using this medicine, they should consult their doctor, nurse, or pharmacist.

4. Possible side effects

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

Some side effects can be serious. The patient should immediately inform their doctor 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.
• Glucose tolerance disturbances.
• 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 stomach pain, 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.
• Abnormal heart rhythm.
• Low platelet count; this may cause increased bleeding or bruising.

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

Other side effects:

If the patient notices any of the following side effects, they should inform their doctor, pharmacist, or nurse. These 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 full in the stomach.
• Fatty stools.
• Loose stools.
• Discoloration of stools.
• Dizziness.
• Lack of appetite.
• Changes in liver function test results.
• Hair loss.
• Shortness of breath.
• Weakness.

If the patient experiences any side effects, they should inform their doctor, nurse, or pharmacist.
Some patients experience pain at the subcutaneous injection site. This pain is usually short-lived. If pain occurs, it can be alleviated by gently rubbing the injection site for a few seconds after administering the medicine.
The occurrence of gastrointestinal side effects may be reduced by avoiding meals shortly before or after subcutaneous administration of Sandostatin, i.e., by injecting between meals or before going to bed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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:
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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sandostatin

The medicine should be stored out of 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.
Ampoules can be stored at a temperature below 30 °C for no more than 2 weeks.
Ampoules should be used immediately after opening.
The diluted solution should be used immediately after preparation.
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 the patient notices solid particles or a change in color.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 contains

• The active substance of the medicine is octreotide. Sandostatin 50 micrograms: 1 ml contains 50 micrograms of octreotide. Sandostatin 100 micrograms: 1 ml contains 100 micrograms of octreotide.
• The other ingredients are: lactic acid, mannitol (E 421), sodium hydrocarbonate, water for injections.

What Sandostatin looks like and contents of the pack

Ampoules of colorless glass with two colored coding rings, containing a clear, colorless solution.
Sandostatin 50 micrograms/1 ml: one blue and one yellow
Sandostatin 100 micrograms/1 ml: one blue and one green
The medicine is available in packs containing 5 ampoules of 1 ml.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Tel. + 48 22 375 48 88

Manufacturer/Importer

Novartis Poland Sp. z o.o.
Marynarska 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 Hungária Kft.
Vasút u.13
Budaörs, 2040
Hungary
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
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
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
Belgium, France, Luxembourg, Netherlands
Sandostatina
Italy, Portugal

Date of last revision of the leaflet: 10/2024

Information intended for healthcare professionals only:

• Intravenous infusion (information intended for healthcare professionals)

Before using the ampoule with Sandostatin, it should be visually checked for solid particles or a change in color. The medicine should not be administered if changes in the appearance of the solution are observed. The solution should be diluted before administering the medicine as an intravenous infusion. Sandostatin (octreotide acetate) is physically and chemically stable for 24 hours in physiological saline or 5% glucose solution in water. Since Sandostatin may affect glucose homeostasis, physiological saline is recommended instead of glucose. Diluted solutions are physically and chemically stable for at least 24 hours at a temperature below 25 °C. From a microbiological point of view, diluted solutions should be used immediately after preparation. If the solution is not used immediately, the user is responsible for the storage time and conditions before use. The contents of one ampoule (500 micrograms) are usually dissolved in 60 ml of 0.9% sodium chloride solution, and the resulting solution should be administered using an infusion pump. This procedure should be repeated as often as necessary to achieve the prescribed treatment time.

How much Sandostatin to use

The dosage of Sandostatin depends on the disease being treated.

• AcromegalyTreatment usually starts with a dose of 0.05 to 0.1 mg administered subcutaneously every 8 or 12 hours. The dose is then adjusted according to the effect and alleviation of symptoms (such as fatigue, sweating, and headache). For most patients, the optimal daily dose is 0.1 mg three times a day. The maximum daily dose should not exceed 1.5 mg.
• Gastrointestinal tumorsTreatment usually starts with a dose of 0.05 mg administered subcutaneously once or twice a day. Depending on the response and tolerance, the dose may be gradually increased to 0.1 mg to 0.2 mg three times a day. In the case of carcinoids, if there is no satisfactory alleviation of symptoms within a week of starting the maximum tolerated dose, treatment should be discontinued.
• Complications after pancreatic surgeryUsually, a dose of 0.1 mg is administered subcutaneously three times a day for 1 week, starting at least 1 hour before surgery.
• Bleeding from esophageal varicesThe recommended dose is 25 micrograms/hour for 5 days in continuous intravenous infusion. During treatment, blood sugar levels should be monitored.
• Pituitary tumors secreting TSHThe usual effective dose is 100 micrograms three times a day subcutaneously. The dose can be adjusted according to the response in TSH and thyroid hormone secretion. Evaluation of treatment efficacy requires treatment to be conducted for at least 5 days.