SANDOSTATIN LAR 20 mg POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

2. What you need to know before you use Sandostatin LAR

Follow all the instructions given by your doctor carefully. They may be different from the information contained in this leaflet.

Read the following instructions before using Sandostatin LAR.

Do not use Sandostatin LAR:

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

Warnings and precautions

Consult your doctor before starting treatment with Sandostatin LAR:

• if you know you currently have gallstones, or have had them in the past, or have any complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform your doctor, as prolonged use of Sandostatin LAR may cause gallstones to form. Your doctor may want to check your gallbladder periodically.
• if you know you have diabetes, as Sandostatin LAR may affect blood sugar levels. If you are diabetic, you should regularly check your blood sugar levels.
• if you have a history of vitamin B12 deficiency, your doctor may periodically check your B12 levels.

Tests and checks

If you receive treatment with Sandostatin LAR for a prolonged period, your doctor may periodically check your thyroid function.

Your doctor will check your liver function.

Your doctor may check your pancreatic enzyme function.

Children

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

Using Sandostatin LAR with other medicines

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

Normally, you can continue taking other medicines while being treated with Sandostatin LAR. However, it has been reported that some medicines such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine are affected by Sandostatin LAR.

If you are taking a medicine to control blood pressure (e.g., a beta-blocker or a calcium channel blocker) or an agent to control 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 going to receive treatment with lutetium (177Lu) oxodotreotide, a radiopharmaceutical, your doctor may interrupt and/or adapt the treatment with Sandostatin LAR for a short period.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Sandostatin LAR should only be used during pregnancy if it is strictly necessary.

Women of childbearing age should use an effective contraceptive method during treatment.

You should not breastfeed while being treated with Sandostatin LAR. It is not known whether Sandostatin LAR passes into breast milk.

Driving and using machines

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

Sandostatin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use Sandostatin LAR

Sandostatin LAR should always be administered as an injection into the muscle of the buttocks. With repeated administration, the right and left buttocks should be used alternately.

If you use more Sandostatin LAR than you should

No life-threatening reactions have been reported after an overdose with Sandostatin LAR.

The symptoms of overdose are: hot flashes, frequent urination, fatigue, depression, anxiety, and lack of concentration.

If you think you have had an overdose and experience any of these symptoms, inform your doctor immediately. You can also call the Toxicology Information Service, Tel. 91 562 0420.

If you forget to use Sandostatin LAR

If you have missed your injection, it is recommended that you have it administered as soon as you remember, and then continue with your usual schedule. It will not harm you to receive a dose a few days late, but your symptoms may temporarily recur until you return to your usual treatment schedule.

If you stop treatment with Sandostatin LAR

If you stop your treatment with Sandostatin LAR, your symptoms may recur. Therefore, do not stop treatment with Sandostatin LAR unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask 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 could be serious. Tell your doctor immediately if you experience any of the following:

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

• Gallstones, which can cause sudden back pain.
• Too much sugar in the blood.

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

• Decreased activity of the thyroid gland (hypothyroidism) which can cause 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 abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
• Too little sugar in the blood.
• Alteration of glucose tolerance.
• 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

• Hypersensitivity reactions (allergic reactions) including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling, and tingling, possibly with a decrease in blood pressure with dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea.
• Inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general feeling of discomfort, itching, lightly colored urine.
• Irregular heartbeat.
• Low platelet count in the blood; this can increase bleeding or bruising.

Tell your doctor immediately if you notice any of the above side effects.

Other side effects:

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects. They 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.
• Flatulence (gas).
• Headache.
• Local pain at the injection site.

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

• Discomfort in the stomach after eating (dyspepsia).
• Vomiting.
• Feeling of having a full stomach.
• Fatty stools.
• Loose stools.
• Change in stool color.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Difficulty breathing.
• Weakness.

If you experience any side effects, talk to your doctor, pharmacist, or nurse.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 (between 2°C and 8°C). Do not freeze.

Sandostatin LAR can be stored below 25°C on the day of injection.

Do not store Sandostatin LAR after reconstitution (it must be used immediately).

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice the presence of particles or a change in color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Sandostatin LAR Composition

• The active ingredient is octreotide.

A vial contains 20 mg of octreotide (as octreotide acetate).

• The other components are:

In the powder (vial): poly(DL-lactic-co-glycolic acid), mannitol (E421).

In the solvent (pre-filled syringe): sodium carboxymethylcellulose, mannitol (E421), poloxamer 188, water for injectable preparations

Appearance of Sandostatin LAR and Container Content

Unitary containers containing a 6 ml glass vial with a rubber stopper (bromobutyl), sealed with an aluminum flip-off cap, containing the powder for injectable suspension and a 3 ml pre-filled glass syringe with a front stopper and a plunger stopper (chlorobutyl rubber) with 2 ml of solvent, packaged together in a sealed blister tray with a vial adapter and a safety injection needle.

Multiples of three unitary containers, each containing: a 6 ml glass vial with a rubber stopper (bromobutyl), sealed with an aluminum flip-off cap, containing the powder for injectable suspension and a 3 ml pre-filled glass syringe with a front stopper and a plunger stopper (chlorobutyl rubber) with 2 ml of solvent, packaged together in a sealed blister tray with a vial adapter and a safety injection needle.

Only some 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 Vía de les Corts Catalanes, 764

08013 Barcelona

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05 1020 Wien Austria

Novartis Pharma NV

Medialaan 40/Bus 1, 1800 Vilvoorde, (Belgium).

Novartis Healthcare A/S

Edvard Thomsens vej 14, DK-2300 Copenhagen S, (Denmark).

Novartis Finland Oy

Metsänneidonkuja 10, 02130 Espoo, (Finland)

Novartis Pharma SAS

8-10 rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison (France)

Novartis Pharma GmbH

Roonstrasse 25, 90429 Nürnberg, (Germany).

Novartis Pharma GmbH

Sophie-Germain-Strasse 10, 90443 Nürnberg (Germany).

Novartis Farma-Produtos Farmacéuticos, 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 Farma S.p.A.

Viale Luigi Sturzo 43, 20154 - Milan (MI) (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 Poland Sp. z o.o.

15 Marynarska Street, 02-674 Warsaw (Poland).

Novartis Hungária Kft.

Vasút u.13, 2040 Budaörs (Hungary).

Abbot Biologicals B.V.

Veerweg, 12. 8121 AA Olst (Netherlands)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:12/2023

Other sources of information

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

This information is intended only for healthcare professionals:

How much Sandostatin LAR should be used

Acromegaly

Treatment should be initiated with the administration of 20 mg of Sandostatin LAR at intervals of 4 weeks for 3 months. Patients being treated with Sandostatin s.c. may initiate treatment with Sandostatin LAR the day after the last dose of Sandostatin s.c.. Subsequent dose adjustment should be based on serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentrations and clinical symptoms.

For patients in whom clinical symptoms and biochemical parameters (GH; IGF-1) are not fully controlled after a period of 3 months (GH concentrations still above 2.5 micrograms/L), the dose may be increased to 30 mg every 4 weeks. If, after 3 months, GH, IGF-1, and/or symptoms are not adequately controlled at the 30 mg dose, the dose may be increased to 40 mg every 4 weeks.

For patients with GH concentrations consistently below 1 microgram/L, and with normalized serum IGF-1 concentrations, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20 mg, 10 mg of Sandostatin LAR may be administered every 4 weeks. However, especially in this group of patients, it is recommended to closely monitor serum GH and IGF-1 concentrations, and signs/symptoms at this low dose of Sandostatin LAR.

For patients being treated with a stable dose of Sandostatin LAR, GH and IGF-1 assessment should be performed every 6 months.

Gastroenteropancreatic neuroendocrine tumors

• Treatment of patients with symptoms associated with functional gastroenteropancreatic neuroendocrine tumors

Treatment should be initiated with the administration of 20 mg of Sandostatin LAR at intervals of 4 weeks. Patients being treated with Sandostatin s.c. should continue at the previously effective dose for 2 weeks after the first injection of Sandostatin LAR.

For patients in whom symptoms and biochemical markers are well controlled after 3 months of treatment, the dose may be reduced to 10 mg of Sandostatin LAR every 4 weeks.

For patients in whom symptoms are only partially controlled after 3 months of treatment, the dose may be increased to 30 mg of Sandostatin LAR every 4 weeks.

For days when symptoms associated with gastroenteropancreatic tumors may increase during treatment with Sandostatin LAR, additional administration of Sandostatin s.c. at the dose used before treatment with Sandostatin LAR is recommended. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.

• Treatment of patients with advanced neuroendocrine tumors of the intestine or unknown origin where the places of origin that are not of intestinal origin have been excluded

The recommended dose of Sandostatin LAR is 30 mg administered every 4 weeks. Treatment with Sandostatin LAR to control the tumor should be continued in the absence of tumor progression.

Treatment of thyrotropin-secreting adenomas

Treatment with Sandostatin LAR should be initiated at a dose of 20 mg at intervals of 4 weeks for 3 months before considering a dose adjustment. Afterward, the dose is adjusted based on TSH and thyroid hormone response.

Instructions for preparation and intramuscular injection of Sandostatin LAR.

FOR INTRAMUSCULAR INJECTION ONLY

Components of the injection kit:

1. A vial containing the Sandostatin LAR powder
2. A pre-filled syringe containing the solvent for reconstitution
3. A vial adapter for reconstitution of the medicinal product
4. A safety injection needle

Follow the instructions below carefully to ensure the reconstitution of Sandostatin LAR before intramuscular injection

There are three critical steps in the Sandostatin LAR reconstitution process. If these are not performed correctly, it may result in inadequate administration of the medicinal product.

• The injection kit must reach room temperature. Remove the injection kit from the refrigerator and let it reach room temperature for at least 30 minutes before reconstitution, but not exceeding 24 hours.
• After adding the diluent solution, let the vial stand for 5 minutes to ensure that the powder is completely saturated.
• After saturation, moderately shake the vialin a horizontal direction for at least 30 seconds until a uniform suspension is formed. The Sandostatin LAR suspension should only be prepared immediatelybefore administration.

Sandostatin LAR must be administered only by an expert healthcare professional.