Sandostatin LAR (Octreotide)
Sandostatin LAR 10, 20 and 30 mg powder and solvent for suspension for injection
(Octreotide)
1.What Sandostatin LAR is and what it’s used for
Sandostatin LAR is a long-acting injection, often called a ‘depot’ injection because the active ingredient is released into the body slowly. This means that you don’t have to have an injection every day. Sandostatin LAR contains the active ingredient octreotide (as the acetate). Octreotide is a synthetic form of the natural hormone, somatostatin. It helps stop the release of some hormones, including growth hormone, in the body.
Sandostatin LAR can be used for two conditions.
1. To treat acromegaly
Acromegaly is a condition where the body produces too much growth hormone. The level of growth hormone controls the growth of tissues, organs and bones. Too much hormone means the size of bones and tissues, especially in the hands and feet, is larger than normal. The symptoms of acromegaly include headache, excessive perspiration, numb hands and feet, tiredness, and joint pain. In most cases, the overproduction of growth hormone is caused by an enlargement in the pituitary gland (a pituitary adenoma).
Sandostatin LAR is used to treat people with acromegaly;
• when daily treatment with Sandostatin injection given subcutaneously (under the skin) has been proved to be satisfactory; (Switching to Sandostatin LAR means that the injections will be much less frequent.)
• when other types of treatment for acromegaly (surgery or radiotherapy) are not suitable or haven’t worked;
• after radiotherapy, to cover the interim period until the radiotherapy becomes fully effective;
• before surgery on the pituitary gland.
2.To relieve stomach or bowel symptoms associated with certain tumours known as ‘gastroenteropancreatic’ tumours (rare tumours of the stomach, bowels or pancreas)
Overproduction of specific hormones and other related natural substances can be caused by some rare conditions of the stomach, bowels or pancreas. This upsets the natural hormonal balance of the body, and results in a variety of symptoms, such as flushing, diarrhoea, low blood pressure, rash, and weight loss. Treatment with Sandostatin LAR helps to control these symptoms. It is generally given to people who have already responded well to treatment with daily Sandostatin injections.
2. Things to consider before you are given Sandostatin LAR
Some people MUST NOT be given Sandostatin LAR. Talk to your doctor if:
• you think you may be allergic to octreotide or to any of the other ingredients of Sandostatin LAR.
You should also ask yourself these questions before having Sandostatin LAR:
• Are you pregnant or breastfeeding?
• Do you have diabetes?
• Do you have any problems with your liver, or have you had a disease which may have affected your liver?
• Have you ever suffered from gallstones or other stomach problems?
• Do you have a history of Vitamin B12 deficiency?
If the answer to any of these questions is YES, tell your doctor or nurse because Sandostatin LAR might not be the right medicine for you.
Are you taking other medicines?
Sandostatin interacts with a large number of other medicines. Tell your doctor or nurse if you
are taking any of the following:
Insulin, or other drugs for diabetes
- Ciclosporin
- Cimetidine
- Bromocriptine
- Medicines to control blood pressure (beta-blockers or calcium channel blockers) or agents to control fluid and electrolyte balance (diuretics)
- Medicines metabolised by the liver for example carbamazepine, digoxin and warfarin and terfenadine.
Always tell your doctor or pharmacist about all the medicines you are taking.
Will there be any problems with driving or using machinery?
No problems have been reported.
Other special warnings
• Your doctor may want to give you a check up from time to time while you are being treated with Sandostatin LAR.
• Growth hormone secreting pituitary tumours may sometimes expand and cause problems. Tell your doctor if you experience any problems with your eyes or sight.
• Tell your doctor if your stomach or bowel problems get worse.
• There is very little experience of using Sandostatin LAR in children.
3. Taking Sandostatin LAR
Your doctor will work out the correct dose for you.
For all adults the starting dose is usually 20 mg Sandostatin LAR, which is given at 4-week intervals. After about the first 3 months of treatment with Sandostatin LAR, your doctor will probably want to reassess your treatment. This may involve measuring the levels of growth hormone or other hormones in your blood. Depending on these results, and on how you are feeling, the dose of Sandostatin LAR may need to be changed. The dose given in each injection can be reduced to 10 mg or, if the treatment is not fully effective, it can be increased to 30 mg. After the most suitable dose for you has been found, your doctor will probably want to reassess your treatment about every 6 months.
Sandostatin LAR must be injected into the gluteal muscles in your buttocks. For repeat injections the doctor or nurse will use the left and right buttocks alternately.
If you have had no problems with Sandostatin injected subcutaneously, you can immediately be changed over to Sandostatin LAR. If you haven’t had Sandostatin before, the doctor will give you a test dose to see how you react, before switching to Sandostatin LAR, if appropriate.
Depending on why you are having Sandostatin LAR, you may need to continue having subcutaneous Sandostatin for about two weeks after your first injection of Sandostatin LAR until it becomes fully effective. You might also occasionally need to use subcutaneous Sandostation as well when your symptoms are troublesome.
When Sandostatin LAR is being used prior to surgery on the pituitary gland, you must have the last dose at least 3 to 4 weeks before the surgery.
Ask your doctor or pharmacist if you are unsure about how much medicine you are being given or how often you are being given it.
What if you forget a dose?
If you forget to go for your appointment for your injection, you should contact your doctor as soon as possible to arrange another appointment.
What if you have had too much? (Overdose)
If you think you have been given the wrong dose talk to the nurse or doctor.
4. Possible side effects
Most people who are prescribed Sandostatin LAR benefit from taking it, but a few can be upset by it. If you are receiving this medicine on a long term basis then you will go to hospital from time to time to have regular check-ups.
Some side effects can be serious
Tell your doctor immediately if you notice that:
• Your face becomes flushed or swollen or you develop spots or a rash
• Your chest feels tight, you become short of breath or wheezy
• You feel faint, possibly as a result of a fall in blood pressure.
These might be the result of an allergic reaction which is rare (likely to affect fewer than 1 in 1,000 patients).
If you develop any of the following see your doctor immediately:
• Prolonged/troublesome bloating of the stomach with pain
• Nausea/vomiting associated with drowsiness
• Feeling restless or giddy
• Yellowing of skin or the whites of your eyes
• Acute pancreatitis (sudden, severe pains in the lower stomach). This may happen within the first few hours or days of treatment and resolves itself upon drug withdrawal.
These other side effects have been reported:
Up to 1 in 10 people have experienced:
• Local pain, swelling or irritation at the site of the injection.
• Stomach ache, wind, diarrhoea or constipation
Up to 1 in 100 people have experienced:
• Slow or fast heart beat
• Gall bladder pain
• Hair loss
Up to 1 in 1,000 people have experienced:
• Gallstones
• Bloated stomach, nausea or vomiting
• Fat in your faeces (pale and fatty loose stools)
• Changes in activity of the thyroid gland (hyper- or hypothyroidism) causing changes in heart rate, appetite or weight, tiredness, feeling cold or sweating too much, anxiety or swelling at the front of the neck
Up to 1 in 10,000 people have experienced:
• Changes in blood sugar levels
• Abnormal liver function
• Loss of appetite
• Loose faeces (stools)
• Shortness of breath.
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
5. How to store Sandostatin LAR
Keep all medicines out of the reach and sight of children.
Sandostatin LAR should be stored in the fridge (between 2°C and 8°C). Keep in the original packaging to protect it from light. Sandostatin LAR can be kept below 25°C on the day of injection, but it must be kept in the outer carton to protect it from light. The suspension must only be prepared immediately before injection.
Do not use Sandostatin LAR after the expiry date which is printed on the outside of the pack.
6. Further information
Sandostatin LAR contains the active ingredient octreotide (as octreotide acetate) in a powder (microspheres) for suspension for injection. The powder also contains the inactive ingredients poly(DL-lactide-co-glycolide) and mannitol. The powder is white to off-white in colour.
Before it can be used, the powder must be suspended in a special liquid (vehicle), which is provided in a pre-filled syringe. This liquid consists of sodium carboxymethylcellulose, mannitol and sterile water. The liquid is clear and colourless.
Once the powder has been mixed with the liquid to be used for suspending the powder, Sandostatin LAR suspension contains less than lmmol (23mg) of sodium per dose i.e. essentially sodium free.
Sandostatin LAR is supplied in a kit which contains
• one 5 ml glass vial containing either 10, 20, or 30 mg octreotide powder (as the acetate),
• one syringe containing 2.5 mL of the liquid to be used for suspending the powder,
• two needles [40 mm (1.5 inch), 19 gauge].
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