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SANDOSTATIN LAR®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about receiving this medicine,
speak to your doctor or pharmacist.
SANDOSTATIN LAR contains the active ingredient octreotide. SANDOSTATIN LAR is used
to treat a few conditions including acromegaly, advanced neuroendocrine tumours of
the gut, and the symptoms of carcinoid tumour and VIPoma. For more information, see
Section 1. Why am I receiving SANDOSTATIN LAR? in the full CMI.
Do not use if you have ever had an allergic reaction to SANDOSTATIN LAR (octreotide)
or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. SANDOSTATIN LAR is
not recommended in these situations. For more information, see Section 2. What should I know before I receive SANDOSTATIN LAR? in the full CMI.
Some medicines may interfere with SANDOSTATIN LAR and affect how it works. A list
of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
SANDOSTATIN LAR must only be administered by a doctor or other healthcare professional
and only into the muscles of your buttocks. The side you receive SANDOSTATIN LAR will
alternate from left to right on each visit you have.
SANDOSTATIN LAR requires a healthcare professional to prepare your dose correctly.
More instructions can be found in Section 4. How will I receive SANDOSTATIN LAR? in the full CMI.
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Things you should do
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Keep all your doctor's appointments so that your progress and overall health can be
checked.
Use contraception (birth control) to avoid becoming pregnant.
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Things you should not do
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Do not use SANDOSTATIN LAR if it has been kept out of the fridge for more than 24
hours.
Do not give this medicine to someone else.
Do not prepare or inject SANDOSTATIN LAR yourself. Your doctor will do this.
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Driving or using machines
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Be careful driving or using machines. May cause dizziness, lightheadedness, or weakness.
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Drinking alcohol
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Tell your doctor if you drink alcohol. May cause dizziness or lightheadedness. Alcohol
may make this worse.
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Looking after your medicine
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Keep the vials in the carton until it is time to use them to protect them from light.
Keep them in the carton, in the refrigerator at 2°C to 8°C. Do not freeze them.
You may remove the carton from the refrigerator on a day you have an injection scheduled.
Do not keep them out of the fridge for longer than 24 hours, otherwise it is not safe
to use them.
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For more information, see Section 5. What should I know while I am receiving SANDOSTATIN LAR? in the full CMI.
More common side effects include Feeling sick, tired, or weak, vomiting, diarrhoea/loose
stools, discoloured stools, constipation, abdominal pain, cramps, feeling bloated
or gassy, indigestion, headache, dizziness, weight changes, redness, swelling or itching
at the injection site, rash, hair loss. More serious side effects include signs of
an allergic reaction such as trouble breathing, wheezing, swelling of the tongue,
lips or face; hives or rash that is spreading, bruising more easily, more bleeding
than normal, gall stones, changes to blood sugar (too high, too low), body temperature
shifts (too hot, too cold), severe abdominal pain or swelling, yellowing of skin or
eyes, trembling, blurred vision, passing very dark urine or little urine, rapid heart
rate (palpitations). For more information, including what to do if you have any side
effects, see Section 6. Are there any side effects? in the full CMI.
SANDOSTATIN LAR (San-do-statin L.A.R)
Active ingredient(s):
Octreotide (ok-TREE-oh-tide)
Consumer Medicine Information (CMI)
This leaflet provides important information about receiving SANDOSTATIN LAR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about receiving SANDOSTATIN LAR.
Where to find information in this leaflet:
SANDOSTATIN LAR contains the active ingredient octreotide.
SANDOSTATIN LAR is an anti-growth hormone agent, meaning it stops the production of
hormones. Sandostatin is derived from somatostatin. Somatostatin is a substance found
in the human body which controls the effects of certain hormones such as insulin and
growth hormone. SANDOSTATIN LAR is used instead of somatostatin because its effects
are stronger and last longer.
SANDOSTATIN LAR is injected into the muscles of your buttocks generally every four
weeks by a doctor or healthcare professional; instead of having to inject short-acting
Sandostatin more frequently under the skin.
SANDOSTATIN LAR is used to treat the following conditions:
Acromegaly
A condition where the body makes too much growth hormone causing you to have bigger
hands and feet than normal. While growth hormone in the body is important as it controls
the growth of your organs and body tissues, it may also cause lots of sweating, headaches,
stiff joints, loss of feeling in hands and feet and sexual dysfunction if you have
too much.
SANDOSTATIN LAR reduces the amount of hormones in your body and may be given to you
when other types of treatment for acromegaly (such as surgery or radiotherapy) are
not suitable or haven’t worked. SANDOSTATIN LAR may also be given to you AFTER radiotherapy,
to cover the interim period until the radiotherapy becomes fully effective.
Relieve the symptoms of certain types of cancer - carcinoid tumour and VIPoma
Carcinoid tumours are a type of slow-growing tumour that can start in several places
in the body. VIPoma however is a type of tumour that generally starts in the pancreas
(the organ that produces insulin). By blocking hormones that are over-produced in
these conditions, SANDOSTATIN LAR can relieve symptoms of these tumours such as flushing
of the skin and severe diarrhoea.
Advanced Neuroendocrine Tumours
Neuroendocrine cells receive signals from the nervous system (like nerve cells) and
respond to this by making hormones (like endocrine cells).
Neuroendocrine tumours can be found in different parts of the body, however SANDOSTATIN
LAR treats rare tumours located in the gut (e.g. small intestine, colon, or appendix)
by blocking these hormones and controlling the growth.
Do not receive SANDOSTATIN LAR if:
you are allergic to octreotide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can receive this medicine. Some of the
symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue, or other parts of the body; rash, itching
or hives on the skin.
Check with your doctor if you have/have had:
gallstones
problems with your liver
diabetes or problems with blood sugar being too high or too low
low vitamin B12
blood pressure issues
problems with your thyroid
problems with your pancreas
any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Monitoring while on treatment
If you are going to be receiving SANDOSTATIN LAR for a while, your doctor may want
to monitor your blood sugar, gallbladder, thyroid, and liver function from time to
time to prevent unwanted side effects from happening.
Your doctor may also want to monitor your pancreas function, especially if you are
taking other medicines to control your blood sugar.
Your doctor may send you for blood tests to monitor your liver enzymes, hormones,
and vitamin B12 as well.
Gallstones
Your doctor will want to know if you have experienced any complications like fever,
chills, abdominal pain, or yellowing of your skin or eyes as prolonged use of SANDOSTATIN
LAR may result in gallstone formation.
Taking other medicines
Your doctor will want to know if you are taking medicines to control blood pressure
(beta-blockers or calcium channel blockers) or agents to control fluid and electrolyte
balance. They may change your dose or treatment plan based on this.
Contraception
You should avoid becoming pregnant while you are receiving SANDOSTATIN LAR. Your doctor
may recommend you take birth control to prevent this.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, think you may be pregnant or intend to
become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if SANDOSTATIN LAR passes into breast milk. You should not breastfeed while undergoing
treatment with SANDOSTATIN LAR.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you can buy without a prescription from your
pharmacy, supermarket, or health food shop.
Some medicines may interfere with SANDOSTATIN LAR and affect how it works.
These medicines can include:
bromocriptine, a medicine which is also used to treat acromegaly
medicines for diabetes
cimetidine, a medicine for ulcers
cyclosporin, a medicine used to suppress the immune system
quinidine, a medicine used to prevent irregular heartbeats
medicines to control blood pressure (beta-blockers or calcium channel blockers)
agents to control fluid and electrolyte balance
some radiotherapies such as those used for neuroendocrine tumours
You may need to take different amounts of your medicines, or you may need to take
different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SANDOSTATIN LAR.
Your doctor or other healthcare professional will administer your treatment directly
into the muscles of your buttocks after they have combined the contents of the packet.
It must ONLY be administered in this location and generally, the side you have it
injected in will alternate each visit.
How much SANDOSTATIN LAR will I receive
Your doctor will decide how much SANDOSTATIN LAR you will receive based on your overall
health, your condition and how you respond to therapy.
Generally
The usual amount of SANDOSTATIN LAR you will receive is 20 mg, injected every 4 weeks.
After about 3 months, the dose may be lowered to 10 mg or increased to 30 mg depending
on how you respond to treatment. Your doctor will decide this.
If receiving SANDOSTATIN LAR for the treatment of neuroendocrine tumours
If you are receiving SANDOSTATIN LAR for the treatment of neuroendocrine tumours located
in the gut, the usual dose is 30 mg every 4 weeks. Your doctor will decide how long
you will receive SANDOSTATIN LAR.
If you are currently taking short-acting Sandostatin
Depending on your condition you may also need to continue injecting short-acting Sandostatin
under the skin for about 2 weeks after your first injection of SANDOSTATIN LAR. Your
doctor will tell you if this is the case.
When to receive SANDOSTATIN LAR
Your doctor or other healthcare professional will discuss with you how often to get
your injection.
If you forget to receive SANDOSTATIN LAR
If you miss your injection or cannot make your appointment for the injection, have
it as soon as you can and then go back to your normal schedule. It will not do any
harm if a dose is a few days late, but you could get some temporary re-appearance
of symptoms until you get back on schedule.
Do not ask your doctor to give you a double dose to make up for the dose you missed.
If you receive too much SANDOSTATIN LAR
If you think that you have received too much SANDOSTATIN LAR, you may need urgent
medical attention.
Some of the symptoms that you have received too much may include hot flushes, fatigue,
depression (sad mood), anxiety, lack of concentration and needing to urinate more
frequently than usual.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Keep all your doctor's appointments so that your progress and overall health can be
checked. These include appointments to check on your liver, gall bladder, thyroid,
pancreas, and blood sugar.
Get your blood and urine tested promptly when asked by your doctor.
Use contraception (birth control) to avoid becoming pregnant.
Call your doctor straight away if you:
Become pregnant or think you may be pregnant. SANDOSTATIN LAR is not recommended in
pregnancy because there is not much information about whether it is safe for you or
your unborn baby.
Remind any doctor, dentist, or pharmacist you visit that you are receiving SANDOSTATIN
LAR.
Things you should not do
Do not take this medicine after the expiry date printed on the packaging, or if it
is damaged, or shows signs of tampering.
Do not take this medicine if it has been left out of the fridge for more than 24 hours.
Do not give this medicine to someone else.
Driving or using machines
Be careful before you drive or use any machines or tools requiring your attention
until you know how SANDOSTATIN LAR affects you.
This medicine may cause dizziness, lightheadedness, or weakness in some people. If
you have any of these symptoms, do not drive or do anything else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
This medicine may cause dizziness or lightheadedness in some people. Alcohol may make
this worse.
Looking after your medicine
While you will generally receive SANDOSTATIN LAR at a hospital administered by doctor
or other healthcare professional, you may be asked to store SANDOSTATIN LAR at home
between visits.
Keep the vials in the carton until it is time to use them as this will protect them
from light.
If you are storing the vials for longer than one day, keep them in the carton, in
the refrigerator between 2°C to 8°C. Do not freeze them.
If you are scheduled to receive a SANDOSTATIN LAR injection that day, you can take
it out of the fridge, but you must store it in a cool dry place (below 25°C) away
from moisture, heat, or sunlight.
For example, do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
SANDOSTATIN LAR should only be administered by your Doctor or other healthcare professional
SANDOSTATIN LAR requires a healthcare professional to prepare your dose correctly.
SANDOSTATIN LAR carton contents should reach room temperature (20°C to 25°C) before
the contents are mixed to prepare for the injection. This will be a minimum of 30
minutes.
The suspension (the mixture that occurs after the powder is combined with the liquid)
must only be made up right before the injection.
Your doctor will have more detailed information about this if you have questions since
you will not need to prepare or administer this yourself.
Keep it where young children cannot reach it.
When to discard your medicine
If any vials have been left out of the fridge for longer than one day (24 hours),
do not use them.
The reconstituted suspension (mixture) contains no preservative. This medicine is
for single use in one patient only. Your doctor or other healthcare professional will
dispose of anything that is left over, after the injection, in a sharps container.
Getting rid of any unwanted medicine
After your doctor or other healthcare professional has administered your treatment,
they will dispose of anything left over in a sharps container.
If your doctor has told you that you no longer need to receive this medicine or it
is out of date or been left out of the fridge for too long, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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General wellness
Feeling tired or weak
Headache
Temporary hair loss
Feeling a little short of breath
Gut problems
Abdominal pain/cramps
Constipation or diarrhoea
Bloating, wind, or change in bowel movements
Indigestion, nausea, vomiting
Loss of appetite
Skin problems
Pain, irritation, redness, rash or swelling at the injection site.
Dry skin
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Speak to your doctor if you have any of these less serious side effects and they worry
you or are making you feel unwell.
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Serious side effects
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Serious side effects
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What to do
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Signs of an allergic reaction
Red, itchy rash that is spreading.
Itchy hives
Swelling of the face, lips, tongue, or other parts of the body
Trouble breathing, wheezing, shortness of breath
Signs of low blood sugar:
Excessive sweating, trembling, dizziness, hungry all the time.
Feeling weak, irregular heartbeat (palpitations), feeling really tired.
Signs of high blood sugar:
Blurred vision
Passing much less urine than normal or very dark urine
Thyroid problems:
Cold sweats, feeling hot and cold, feeling anxious
Swelling of the neck
Significant weight gain
Gall bladder/liver problems:
Severe pain, tenderness or swelling in the stomach or abdomen while feeling/being
sick
Yellowing of the skin and eyes, loss of appetite, generally feeling unwell
Light coloured urine
Gallstones, may present with back pain
Bleeding problems:
Increased bleeding or bruising (could be low level of platelets in blood).
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What SANDOSTATIN LAR contains
SANDOSTATIN LAR vials contain 10 mg, 20 mg or 30 mg of the active ingredient, octreotide
(as acetate).
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Active ingredient
(main ingredient)
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Octreotide
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Other ingredients
(inactive ingredients)
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Vial contents
mannitol
polyglactin glucose
Syringe contents
mannitol
carmellose sodium
poloxamer
water for injections
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Potential allergens
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-
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Do not take this medicine if you are allergic to any of these ingredients.
What SANDOSTATIN LAR looks like
SANDOSTATIN LAR is a white to white with yellowish tint powder packed in a glass vial.
The diluent (liquid) is a clear, colourless to slightly yellow or brown solution.
Each box of SANDOSTATIN LAR contains one 6mL glass vial of powder, a 3mL glass syringe
already containing the diluent (liquid) to mix with the powder, a vial adaptor and
safety injection needle.
The vial contents need to be suspended in diluent prior to injection. Your doctor
will do this before they administer your treatment. If you have any questions about
the contents of the pack, speak to your doctor.
SANDOSTATIN LAR is available as:
SANDOSTATIN LAR octreotide (as acetate) 10 mg modified release injection plus diluent
(AUST R 227962)
SANDOSTATIN LAR octreotide (as acetate) 20 mg modified release injection plus diluent
(AUST R 227963)
SANDOSTATIN LAR octreotide (as acetate) 30 mg modified release injection plus diluent
(AUST R 227964)
