10 mg, 20 mg, and 30 mg powder and solvent for suspension for injection
octreotide
What Sandostatin LAR is and what it is used for
Sandostatin LAR is a synthetic version of somatostatin. Somatostatin occurs naturally in the body where it inhibits the release of one of the certain hormones such as. growth hormone. The advantages of Sandostatin LAR compared to somatostatin are that it is stronger and that the effect lasts longer.
Sandostatin LAR is used
- to treat acromegaly,
Acromegaly is a condition in which the body produces too much growth hormone. Normally, growth hormone controls the growth of tissues, organs, and bones. Too much growth hormone causes the size of your bones and tissues to increase, especially in your hands and feet. Sandostatin LAR significantly reduces the symptoms of acromegaly, which include headaches, excessive sweating, numbness in the hands and feet, fatigue, and joint pain. In most cases, overproduction of growth hormone is caused by an enlargement of the pituitary gland (a pituitary adenoma); treatment with Sandostatin LAR may reduce the size of the adenoma.
Sandostatin LAR is used to treat people with acromegaly:
- when other types of acromegaly treatment (surgery or radiation therapy) are not appropriate or have not worked;
- after radiation treatment, to cover the transition period until the radiation treatment becomes fully effective.
- to relieve symptoms associated with overproduction of certain hormones and other similar substances in the stomach, intestines, or pancreas,
Overproduction of certain hormones and other natural substances can be caused by rare conditions in the stomach, intestines, or pancreas. This upsets the natural hormone balance in the body and results in a variety of symptoms, such as redness, diarrhea, low blood pressure, rash, and weight loss. Treatment with Sandostatin LAR helps control these symptoms.
- to treat neuroendocrine tumors located in the intestine (eg appendix, small intestine, or colon )
Neuroendocrine tumors are rare tumors that can be found in different parts of the body. Sandostatin LAR is also used to control the growth of these tumors when they are located in the intestine (eg the small intestine, small intestine, or large intestine).
- to treat pituitary tumors that produce too much thyroid-stimulating hormone ( TSH ).
Too much thyroid-stimulating hormone ( TSH ) leads to hyperthyroidism. Sandostatin LAR is used to treat people with pituitary tumors that produce too much thyroid-stimulating hormone ( TSH ):
- when other types of treatments ( surgery or radiation therapy) are not appropriate or have not worked;
- after radiation treatment to cover the transition period until the radiation treatment becomes fully effective.
Octreotide contained in Sandostatin LAR may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sandostatin LAR
Carefully follow all instructions given to you by your doctor. They may differ from the information in this leaflet.
Read the following explanations before using Sandostatin LAR.
Do not use Sandostatin LAR:
– if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Sandostatin LAR:
- If you know you have gallstones or have had it before or if you experience other complications such as fever, chills, abdominal pain, yellow skin, or yellow eyes, tell your doctor as long-term use of Sandostatin LAR can lead to gallstone formation. Your doctor may want to check your gallbladder at regular intervals.
- if you know you have diabetes because Sandostatin LAR can affect your blood sugar levels. If you are diabetic, your sugar levels should be checked regularly.
- If you have had a B12 deficiency in the past, your doctor may want to check your B12 levels at regular intervals.
Sampling or controls
If you are being treated with Sandostatin LAR for a long time, your doctor may want to check your thyroid function at regular intervals.
Your doctor will check your liver function.
Your doctor may want to check your pancreatic enzyme function.
Children and young people
Experience with Sandostatin LAR in children is limited.
Other medicines and Sandostatin LAR
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
You can usually continue to take other medicines while you are being treated with Sandostatin LAR. However, certain drugs such as cimetidine, ciclosporin, bromocriptine, quinidine, and terfenadine have been reported to be affected by Sandostatin LAR.
If you are being treated with medicine to control your blood pressure (such as a beta-blocker or a calcium channel blocker) or medicine to regulate your fluid and electrolyte balance, your doctor may need to adjust your dose.
If you are diabetic, your doctor may need to adjust your insulin dose.
If you are being treated with lutetium ( 177 Lu) oxodotreotide, a radioactive medicine, your doctor may stop and/or adjust your treatment with Sandostatin LAR for a short period.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sandostatin LAR should only be used during pregnancy if necessary.
Female patients who may become pregnant should use a safe method of contraception during treatment.
Do not breastfeed during treatment with Sandostatin LAR. It is not known if Sandostatin LAR passes into breast milk.
Driving and using machines
Sandostatin LAR has no or negligible effect on the ability to drive and use machines. However, some of the side effects that you may get from treatment with Sandostatin LAR, such as headaches and fatigue, may impair your ability to drive and use machines safely.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sandostatin LAR contains sodium
Sandostatin LAR contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Sandostatin LAR
Sandostatin LAR should always be given as an injection into the gluteal muscle. With repeated administration, alternate between the left and right gluteal muscles.
If you use more Sandostatin LAR than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
No life-threatening reactions have been reported following an overdose of Sandostatin LAR.
The symptoms of overdose are hot flashes, frequent urination, fatigue, depression, anxiety, and difficulty concentrating.
If you think you have had an overdose and are experiencing such symptoms, talk to your doctor immediately.
If you forget to use Sandostatin LAR
If you have missed your injection, it is recommended that you receive it as soon as possible and that the treatment then continues as usual. It does not hurt if you receive a dose a few days late, but you can temporarily get symptoms back before you are back on the dosing schedule.
If you stop using Sandostatin LAR
If you stop taking Sandostatin LAR, your symptoms may return. Therefore, you should not stop treatment unless your doctor advises you to do so.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Talk to your doctor immediately if you get any of the following:
Very common (may affect more than 1 in 10 people):
- Gallstones that cause sudden back pain.
- High blood sugar.
Common (may affect up to 1 in 10 people):
- Underactive thyroid gland (hypothyroidism) which causes changes in heart rate, appetite, or weight; fatigue, coldness, or swelling on the front of the throat.
- 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.
- Impaired glucose tolerance.
- Slow heartbeat.
Uncommon (may affect up to 1 in 100 people):
- Thirst, low urine production, dark urine, dry reddened skin.
- Fast heartbeat.
Other serious side effects are
- Hypersensitivity reaction (allergic) including skin rash.
- A type of allergic reaction ( anaphylaxis ) that can cause difficulty swallowing or breathing, swelling and tingling, and even drops in blood pressure that can lead to dizziness or unconsciousness.
- Inflammation of the pancreas ( pancreatitis ); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, and diarrhea.
- Inflammation of the liver ( hepatitis ); Symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general malaise, itching, and light-colored urine.
- Irregular heartbeats.
- Low platelet count, may lead to an increased tendency for bleeding or bruising.
Talk to your doctor immediately if you experience any of the side effects listed above.
Other side effects:
Tell your doctor, pharmacist, or nurse if you notice any of the side effects below. They are usually mild and tend to disappear during treatment.
Very common (may affect more than 1 in 10 people):
- Diarrhea.
- Stomach pain.
- Nausea.
- Constipation.
- Gas formation.
- Headache
- Pain at the injection site.
Common (may affect up to 1 in 10 people):
- Stomach upset after a meal ( dyspepsia ).
- Vomiting.
- Feeling full.
- Fatty stools.
- Loose stools.
- Discolored stools.
- Dizziness.
- Loss of appetite.
- Changes in liver function tests.
- Hair loss.
- Respiratory distress.
- Faintness
If you get any side effects, talk to your doctor, pharmacist, or nurse.
How to store Sandostatin LAR
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Sandostatin LAR can be stored at a maximum of 25 ° C during the injection day.
Sandostatin LAR should be used immediately after reconstitution and not saved for later use.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice particles or discoloration.
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 to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is octreotide.
- One vial contains 10 mg, 20 mg or 30 mg octreotide (as octerotide acetate).
- Other ingredients are:in powder: poly- (DL-lactide-co-glycolide), mannitol (E421).in diluent: caramel sodium, mannitol (E421), poloxamer 188, water for injections.
What the medicine looks like and the contents of the pack
Unit packs containing a 6 ml glass vial with a rubber stopper
(bromobutyl rubber), sealed with an aluminum snap cap, with powder for injection, suspension, and a 3 ml colorless pre-filled glass syringe with front stopper and plunger stopper (chlorobutyl rubber) with 2 ml of diluent, packaged in a sealed blister pack with a vial for a syringe adapter.
Multipack of three-unit packs, each containing a 6 ml glass vial with a rubber stopper (bromobutyl rubber), sealed with an aluminum snap cap, with powder for solution for injection, and a 3 ml colorless pre-filled glass syringe with front stopper and flask stopper (chlorobutyl rubber) with 2 ml diluent, packaged in a sealed blister pack with a bottle adapter and a safety needle for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Sverige AB
Box 1218
164 28 Kista
Tel. 08-732 32 00.
For any information about this medicine, please contact the Marketing Authorization Holder.
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Bulgaria, Cyprus, Denmark, Estonia, Finland, United Kingdom (Northern Ireland), Greece, Iceland, Ireland, Croatia, Latvia, Lithuania, Malta, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, Germany, Hungary, Austria, | Sandostatin LAR |
| Belgium, Luxembourg, the Netherlands | Sandostatin LAR |
| Italy, Portugal | Sandostatin LAR |
| France |