Sandostatin 50 micrograms/ml solution for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

SANDOSTATIN 50 micrograms/ml solution for injection and infusion

octreotide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Sandostatin is and what it is used for

Sandostatin is a synthetic compound derived from somatostatin, a substance naturally present in the human body that inhibits the effects of certain hormones such as growth hormone. The advantages of Sandostatin over somatostatin are that it is more potent and its effects last longer.

Sandostatin is used

• for the treatment of acromegaly, a condition in which the body produces too much growth hormone. Normally, growth hormone regulates the growth of tissues, organs, and bones. Excess growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. Sandostatin significantly reduces the symptoms of acromegaly, including headache, excessive sweating, numbness in the hands and feet, fatigue, and joint pain.
• to relieve symptoms associated with certain gastrointestinal tract tumours (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas, GRFomas). In these conditions, there is an overproduction of specific hormones and other related substances by the stomach, intestine, or pancreas. This overproduction disrupts the body's natural hormonal balance and causes various symptoms such as flushing, diarrhoea, low blood pressure, urticaria, and weight loss. Treatment with Sandostatin helps control these symptoms.
• to prevent complications following pancreatic gland surgery. Treatment with Sandostatin helps reduce the risk of postoperative complications (e.g. abdominal abscesses, inflammation of the pancreatic gland).
• to stop bleeding and to protect against recurrence of bleeding from ruptured gastroesophageal varices in patients with cirrhosis (a chronic liver disease). Treatment with Sandostatin helps control bleeding and reduce the need for blood transfusions.
• to treat pituitary tumours that produce too much thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) causes hyperthyroidism.

Sandostatin is used to treat people with pituitary tumours that produce too much thyroid-stimulating hormone (TSH):

• when other types of treatment (surgery or radiotherapy) are not suitable or have not been effective;

• after radiotherapy, to cover the period until the radiotherapy becomes fully effective.

2. What you need to know before using Sandostatin

Do not use Sandostatin:

• if you are allergic to octreotide or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Sandostatin:

• if you currently have gallstones, have had them in the past, or experience any complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform your doctor, as long-term use of Sandostatin may lead to the formation of gallstones. Your doctor may wish to monitor your gallbladder periodically.

• if you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycemia). When Sandostatin is used to treat bleeding from gastroesophageal varices, monitoring of blood sugar levels is mandatory.

• if you have a history of vitamin B12 deficiency, your doctor may monitor your B12 levels periodically.

• octreotide may reduce heart rate and, at very high doses, may cause an abnormal heart rhythm. Your doctor may monitor your heart rate during treatment.

Tests and monitoring

If you are receiving Sandostatin for a prolonged period, your doctor may periodically monitor your thyroid function.

Your doctor will monitor your liver function.

Your doctor may check the function of your pancreatic enzymes.

Children

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

Other medicines and Sandostatin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You can usually continue taking other medicines while being treated with Sandostatin. However, it has been reported that certain medicines such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine may be affected by Sandostatin.

If you are taking a medicine to control blood pressure (e.g. a beta-blocker or a calcium channel antagonist) or an agent to regulate fluid and electrolyte balance, your doctor may need to adjust the dose.

If you are diabetic, your doctor may need to adjust your insulin dose.

If you are to receive treatment with lutetium (177Lu) oxodotreotide, a radiopharmaceutical, your doctor may interrupt and/or adapt your Sandostatin treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Sandostatin should only be used during pregnancy if strictly necessary.

Women of childbearing potential should use an effective method of contraception during treatment.

Breastfeeding must be avoided during treatment with Sandostatin. It is unknown whether Sandostatin passes into breast milk.

Driving and using machines

Sandostatin has no or negligible effects on the ability to drive or use machines. However, some of the adverse effects you may experience during treatment with Sandostatin, such as headache and fatigue, may reduce your ability to drive or operate machinery safely.

Sandostatin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially “sodium-free”.

3. How to use Sandostatin

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If you are unsure, consult your doctor or pharmacist again.

Depending on the condition being treated, Sandostatin is administered either by:

• subcutaneous injection (under the skin), or
• intravenous infusion (into the vein).

If you have liver cirrhosis (chronic liver disease), your doctor may need to adjust your maintenance dose.

Your doctor or nurse will explain how to inject Sandostatin under the skin. However, intravenous infusion must always be performed by a healthcare professional.

• Subcutaneous injection

The upper arms, thighs, and abdomen are suitable areas for subcutaneous injection.

A new injection site should be selected for each subcutaneous injection to avoid irritating a specific area. Patients who will self-administer the injection must receive specific instructions from their doctor or nurse.

If you store the medicine in the refrigerator, it is recommended that you allow it to reach room temperature before use. This will reduce the risk of injection site pain. You may warm the medicine in your hands, but do not heat it.

A small number of patients experience pain at the subcutaneous injection site. This pain usually lasts only a short time. If this happens to you, you may relieve it by gently massaging the injection site for a few seconds afterward.

Before using a Sandostatin vial, check for the presence of particles or any change in color. Do not use it if you notice anything abnormal.

If you use more Sandostatin than you should

Symptoms of overdose include: irregular heartbeat, low blood pressure, cardiac arrest, reduced oxygen supply to the brain, severe upper abdominal pain, yellowing of the skin and eyes, nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, abdominal swelling, abdominal discomfort, high blood lactate levels, and abnormal heart rhythm.

If you think you have overdosed and experience any of these symptoms, inform your doctor immediately.

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service, Tel. 91 5620420.

If you forget to use Sandostatin

Administer the dose as soon as you remember, then continue with your regular dosing schedule. Forgetting a dose will not harm you, but your symptoms may temporarily return until you resume your regular treatment schedule.

Do not inject a double dose to make up for a missed dose.

If you stop using Sandostatin

If you stop treatment with Sandostatin, your symptoms may return. Therefore, do not stop treatment with Sandostatin unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse reactions could be serious. Inform your doctor immediately if you experience any of the following:

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

• Gallstones, leading to sudden back pain.
• High blood sugar levels.

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

• Decreased activity of the thyroid gland (hypothyroidism), causing changes in heart rate, appetite, or weight; fatigue, feeling cold, or swelling in the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); 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-colored urine, dry red skin.
• Fast heart rate.

Other serious adverse reactions:

• Hypersensitivity (allergic) reactions, including skin hives.
• A type of allergic reaction (anaphylaxis) that may cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure leading to dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis); symptoms may include sudden upper abdominal pain, nausea, vomiting, diarrhoea.
• Inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general feeling of being unwell, itching, and lightly coloured urine.
• Irregular heartbeat.
• Low platelet count in the blood; this may result in increased bleeding or bruising.

Inform your doctor immediately if you notice any of the above adverse reactions.

Other adverse effects:

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects listed below. These are usually mild and tend to disappear as treatment progresses.

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

• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence (gas).
• Headache.
• Local pain at the injection site.

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

• Stomach discomfort after eating (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Watery stools.
• Change in stool color.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Difficulty breathing.
• Weakness.

If you experience any kind of adverse effect, consult your doctor, nurse, or pharmacist.

A few patients experience pain at the site of subcutaneous injection. This pain usually lasts only a short time. If this happens to you, you may relieve it by gently massaging the injection site for a few seconds.

If you are administered Sandostatin by subcutaneous injection, you may reduce the risk of gastrointestinal adverse effects by avoiding meals close to the time of injection. Therefore, it is recommended to administer Sandostatin between meals or at bedtime.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sandostatin

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

Store in the original packaging to protect from light.

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

Vials may be stored below 30°C for up to two weeks. Vials should be used immediately after opening.

Diluted solutions should be used immediately after preparation.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if visible particles are present or if a change in colour is observed.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Contents of Sandostatin

• The active substance is octreotide. 1 ml of solution contains 50 micrograms of octreotide.

• The other components are: lactic acid, mannitol (E421), sodium bicarbonate, water for injections.

Appearance of the product and contents of the container

Colorless glass ampoule with two colored rings (one blue and one yellow) containing a clear, colorless solution.

Packs of three, five, six, ten, twenty and fifty ampoules.

Multiple packs of 10 packs, each containing three ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona

Manufacturer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona

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 Farma-Produtos Farmacêuticos, SA
Avenida Professor Doutor Cavaco Silva nº10E, Taguspark, 2740-255 Porto Salvo (Portugal)

Novartis Farma S.p.A.
Via Provinciale Schito 131, 80058 Torre Annunziata, NA (Italy)

Novartis Sverige AB
Torshamnsgatan 48, 164 40 Kista (Sweden)

Novartis (Hellas) S.A.
12th km National Road Athinon-Lamia, 14451 Metamorphosis Attiki (Greece)

Novartis Pharma B.V.
Haaksbergweg 16, 1101 BX Amsterdam (Netherlands)

Novartis Hungária Kft.
Vasút u.13, 2040 Budaörs (Hungary)

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 12/2023

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

• Intravenous infusion (for healthcare professionals)

Visually inspect the medicine for any change in colour or for visible particles before administration. Do not use if any abnormality is observed. For intravenous infusion, dilute the medicine before administration.

Sandostatin (octreotide acetate) is physically and chemically stable for 24 hours in sterile physiological saline solution or sterile 5% dextrose (glucose) in water. However, since Sandostatin may affect glucose homeostasis, it is recommended that physiological saline solutions be used instead of dextrose.

Diluted solutions are physically and chemically stable for at least 24 hours below 25°C. From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user.

The contents of a 500 microgram vial should normally be dissolved in 60 ml of saline, and the resulting solution should be administered via an infusion pump. This should be repeated as necessary until the prescribed treatment duration is achieved.

How much Sandostatin should be used

The dose of Sandostatin depends on the disease being treated.

• Acromegaly

Treatment is normally initiated at doses of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. The dose is subsequently adjusted according to its effects and symptom relief (such as fatigue, sweating, and headache). In most patients, the optimal daily dose will be 0.1 mg three times daily. The maximum dose of 1.5 mg/day should not be exceeded.

• Gastrointestinal tract tumours

Treatment is normally initiated at a dose of 0.05 mg once or twice daily by subcutaneous injection. Depending on response and tolerability, the dose may be gradually increased to 0.1 mg to 0.2 mg three times daily. In carcinoid tumours, treatment should be discontinued if no improvement is observed after 1 week of treatment at the maximum tolerated dose.

• Complications following pancreatic surgery

The normal dose is 0.1 mg three times daily by subcutaneous injection for 1 week, starting at least 1 hour before surgery.

• Gastro-oesophageal variceal bleeding

The recommended dose is 25 micrograms/hour for 5 days by continuous intravenous infusion. Blood glucose levels must be monitored during treatment.

• TSH-secreting pituitary adenomas

The usual effective dose is 100 micrograms three times daily by subcutaneous injection. The dose may be adjusted according to TSH and thyroid hormone response. At least 5 days are required to assess efficacy.