Sandostatin 0.1 mg/mL solution for injection/infusion – octreotide for acromegaly and neuroendocrine tumours

Sandostatin is a medicine in the form of a solution for injection/infusion containing octreotide (as octreotide acetate) – a synthetic compound derived from somatostatin, a natural substance that inhibits the release of certain hormones such as growth hormone. Compared with somatostatin, octreotide acts more strongly and for longer.

One 1 mL ampoule contains 0.1 mg of octreotide; the pack contains 5 ampoules. The medicine is given by subcutaneous injection or intravenous infusion. It is used primarily in healthcare institutions and may exceptionally be dispensed on prescription to continue treatment at home.

What is Sandostatin used for and how should it be given correctly?

Key information about the medicine

What is Sandostatin used for?

According to the package leaflet, Sandostatin is used:

• to treat acromegaly (excess growth hormone production) when surgery or radiotherapy has not controlled the disease, in patients unsuitable for surgery or until radiotherapy takes full effect;
• to relieve symptoms of certain gastrointestinal tumours (carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas) – flushing, diarrhoea and others; according to the Summary of Product Characteristics, Sandostatin is not an antitumour medicine and is not intended to cure tumours;
• to prevent complications after pancreatic surgery;
• to stop bleeding and prevent rebleeding from enlarged veins in the oesophagus and stomach (varices) in patients with cirrhosis, together with endoscopic treatment;
• to treat pituitary tumours that produce too much TSH, when other treatments are unsuitable or until radiotherapy takes full effect.

How is Sandostatin used and dosed?

The dose is determined by the doctor according to the disease, response and tolerability. According to the information for healthcare professionals:

• Acromegaly: initially 0.05–0.1 mg subcutaneously every 8 or 12 hours; the optimal daily dose in most patients is 0.3 mg, the maximum 1.5 mg a day. If there is no significant improvement within 3 months, treatment is stopped.
• Gastroenteropancreatic endocrine tumours: initially 0.05 mg once or twice daily subcutaneously, gradually increased to 0.1–0.2 mg three times daily.
• After pancreatic surgery: 0.1 mg three times daily subcutaneously for 7 days, with the first dose at least 1 hour before surgery.
• Variceal bleeding: 25 micrograms per hour by continuous intravenous infusion for 5 days (in hospital).
• TSH-secreting pituitary tumours: usually 100 micrograms three times daily subcutaneously.

The subcutaneous injection is given into the upper arm, thigh or abdomen, at a new site each time. Patients who inject themselves must receive precise instructions from a doctor or nurse; an intravenous infusion is always given by a healthcare professional. Let an ampoule from the fridge reach room temperature before use (you can warm it in your hand) – this reduces pain. To reduce digestive complaints, inject between meals or in the evening before bedtime.

Special patient groups

• Children: experience is very limited.
• Elderly patients: no change in dosing is needed.
• Liver cirrhosis: the elimination half-life may be prolonged, so the doctor may adjust the maintenance dose.
• Kidney impairment: no dose adjustment is needed.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to octreotide or any of the excipients.

Precautions and warnings

Talk to your doctor before using the medicine:

• if you have or have had gallstones or their complications (fever, chills, abdominal pain, jaundice);
• if you have diabetes or a tendency to low blood sugar – when used for variceal bleeding, blood sugar is monitored regularly;
• if you have had vitamin B12 deficiency in the past – the doctor may check your levels periodically;
• if you have heart problems – the medicine may slow the heart rate.

During long-term treatment the doctor periodically checks thyroid and liver function and pancreatic enzymes. The medicine is essentially sodium-free.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take. In general you can continue other medicines, but:

• Sandostatin may affect the action of cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine;
• with blood pressure medicines (beta-blockers, calcium channel blockers) or diuretics the doctor may adjust the dose;
• diabetics may need their insulin dose adjusted;
• before treatment with the radiopharmaceutical lutetium (177Lu) oxodotreotide the doctor may stop or adjust Sandostatin.

Pregnancy and breast-feeding

Sandostatin should be used during pregnancy only if truly necessary. Women of childbearing potential must use effective contraception during treatment. Do not breast-feed during treatment – it is not known whether the medicine passes into breast milk.

Driving and using machines

The medicine has no or negligible influence on the ability to drive, but dizziness, tiredness and headache may reduce this ability – in that case do not drive.

Possible side effects

• Very common (more than 1 in 10 patients): gallstones, raised blood sugar, diarrhoea, abdominal pain, nausea, constipation, wind, headache, injection-site reaction.
• Common (up to 1 in 10): reduced thyroid function, inflammation of the gallbladder, low blood sugar, impaired glucose tolerance, slow heart rate, discomfort after meals, vomiting, feeling of fullness, fatty, soft or discoloured stools, dizziness, loss of appetite, changes in liver tests, hair loss, shortness of breath, weakness.
• Uncommon (up to 1 in 100): thirst, reduced urine output, dark urine, dry and flushed skin (dehydration), fast heart rate.
• Other serious effects: allergic reactions and anaphylaxis, pancreatitis, hepatitis, irregular heartbeat, low platelet count.
• Pain at the subcutaneous injection site usually lasts a short time and can be eased by gently rubbing for a few seconds.

Overdose, missed dose and stopping treatment

• Overdose: irregular heartbeat, low blood pressure, severe upper abdominal pain, jaundice, nausea, diarrhoea, weakness and lactic acidosis are possible – tell your doctor immediately.
• Missed dose: give one dose as soon as you remember and continue with the usual schedule. Do not inject a double dose.
• Stopping treatment: do not stop the medicine without your doctor's advice – symptoms may return.

Related information

Octreotide treatment is carried out with regular check-ups with an endocrinologist or gastroenterologist, including periodic gallbladder ultrasound and blood sugar and thyroid function tests.

Composition, pack and manufacturer

• Active substance: octreotide (as octreotide acetate) – 0.1 mg per 1 mL ampoule.
• Excipients: lactic acid; mannitol; sodium hydrogen carbonate; water for injections.
• Appearance: clear, colourless solution.
• Pack: colourless glass ampoule (type I) with one-point-cut opening and green and blue rings; 5 ampoules of 1 mL per carton.
• Marketing authorisation holder: Novartis Pharma Services Inc. Representative Office Belgrade (Novi Beograd), Omladinskih brigada 90A. Manufacturers: Novartis Pharma Stein AG, Switzerland; Novartis Pharma GmbH, Nuremberg, Germany.
• Marketing authorisation number: 515-01-00857-22-001 of 27 February 2023.

Storage

• Store in a refrigerator (2 °C to 8 °C), in the original package to protect from light. Do not freeze. The medicine may be kept at up to 30 °C for no more than 2 weeks.
• Shelf life: 3 years. Use the solution immediately after opening the ampoule or diluting; do not use if it contains particles or has changed colour.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Does Sandostatin cure the tumour?

No. According to the Summary of Product Characteristics, Sandostatin is not an antitumour medicine and is not intended to cure tumours – in gastroenteropancreatic endocrine tumours it is used to relieve symptoms such as flushing and diarrhoea.

Can I give the injections myself at home?

A patient can give the subcutaneous injection, but only after receiving precise instructions from a doctor or nurse. An intravenous infusion is always given by a healthcare professional.

How can I reduce pain at the injection site?

An ampoule stored in the fridge should reach room temperature before use (you can warm it in your hand). Rotate injection sites, and brief pain can be eased by gently rubbing for a few seconds.

Why does the doctor check my gallbladder?

Long-term use of octreotide may lead to gallstones, which is a very common side effect. That is why the doctor periodically checks the gallbladder.

Sources

• ALIMS – Package leaflet, Sandostatin 0.1 mg/mL (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Sandostatin 0.1 mg/mL (SmPC, Serbian)

Sources checked on: 25 October 2026.