Octreotide (as acetate)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Octreotide Depot. It does not contain
all the available information. It does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Octreotide Depot against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Octreotide Depot is used for
Octreotide Depot is a long acting form of octreotide injection. It is injected into
the buttocks once every 4 weeks, instead of having frequent injections of the octreotide
under the skin.
Octreotide Depot is used to treat acromegaly
In people with acromegaly the body makes too much growth hormone which controls the
growth of tissues, organs and bones. Too much growth hormone leads to enlargement
of the bones, especially of the hands and feet. Other symptoms include headaches,
increased sweating, tiredness, numbness of the hands and feet, pain and stiffness
in the joints and loss of sexual function. By blocking the excess growth hormone,
Octreotide Depot can relieve many of these symptoms.
Octreotide Depot is used to relieve symptoms of certain types of cancer such as carcinoid
tumour and VIPoma.
By blocking hormones that are over-produced in these conditions, Octreotide Depot
can relieve symptoms such as flushing of the skin and severe diarrhoea. Octreotide
Depot contains octreotide, a man-made medicine 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. Octreotide Depot is used instead of somatostatin
because its effects are stronger and last longer.
Octreotide Depot is used to treat advanced neuroendocrine tumours located in the gut
(eg appendix, small intestine or colon).
Neuroendocrine tumours are rare tumours which can be found in different parts of the
body. Octreotide Depot is also used to control the growth of these tumours, when they
are located in the gut (eg appendix, small intestine or colon).
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
There is very little information on the use of this medicine in children.
Before you have Octreotide Depot
When you must not have it
Do not take Octreotide Depot if you have an allergy to:
octreotide (the active ingredient in Octreotide Depot) or any of the other ingredients
listed at the end of this leaflet.
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
Do not have this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you have it
Tell your doctor if you have or have had any of the following medical conditions:
gallstones now or in the past or experience any complications like fever, chills,
abdominal pain, or yellowing of your skin or eyes as prolonged use of Octreotide Depot
may result in gallstone formation
problems with your blood sugar levels, either too high (diabetes) or too low (hypoglycaemia)
problems with your liver
a history of vitamin B12 deprivation
problems with your blood pressure
problems with your thyroid
problems with your pancreas
Your doctor may want to take special precautions if you have any of these conditions.
Tell your doctor if you are taking other medicines to control blood pressure (beta-blockers
or calcium channel blockers) or agents to control fluid and electrolyte balance.
Dose adjustment may be necessary.
Tell your doctor if you are pregnant or plan to become pregnant or wish to breast-feed
your baby.
There is not much information on the use of Octreotide Depot during pregnancy or breast-feeding.
If it is necessary for you to have this medicine, your doctor will discuss with you
the benefits and risks involved. They may recommend that you use a method of contraception
to prevent pregnancy during your treatment. It is not known if Octreotide Depot passes
into breast milk. Breastfeeding is not recommended during treatment with Octreotide
Depot.
If you have not told your doctor about any of the above, tell him/her before you have
Octreotide Depot.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Octreotide Depot may interfere with each other. These 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
You may need different amounts of your medicines, or you may need to take different
medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while having this medicine.
How Octreotide Depot is given
Your doctor or nurse will inject Octreotide Depot into your buttocks.
How much is given
The usual starting dose of Octreotide Depot 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 it.
Depending on your condition you may also need to continue injecting octreotide under
the skin for about 2 weeks after your first injection of Octreotide Depot. Your doctor
will tell you if this is the case.
If you receive Octreotide Depot 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 should be treated with Octreotide Depot.
If you forget to have it
If you forget to have your injection, have it as soon as you remember and then go
back to your normal schedule.
It will not do any harm if your dose is a few days late but some of your symptoms
may come back temporarily until you get back on schedule.
If you are given too much (overdose)
Tell your doctor if you notice any of the following signs that the dose of Octreotide
Depot is too high.
Some of the symptoms of an Octreotide Depot overdose may include hot flushes, fatigue,
depression (sad mood), anxiety, lack of concentration and needing to pass water more
frequently than usual.
If you are taking short acting octreotide injected under the skin, overdose symptoms
may include changes in heartbeat, dizziness, light headedness, severe radiating chest
pain, change in attention, uncoordinated movement, pain under the rib cage (right
side), distended stomach, yellowing of the skin and eyes, fever, severe upper stomach
pain with nausea and vomiting, diarrhoea, weakness, feeling lethargic, weight loss,
stomach pain and discomfort, brown coloured urine and clay-coloured stools, nausea,
weakness.
No life-threatening reactions have been reported after an overdose of this medicine.
While you are having Octreotide Depot
Things you must do
Keep all of your doctor's appointments so that your progress can be checked.
If you must have this medicine for a long time, your doctor may want to check your
blood sugar, gallbladder, thyroid and liver function from time to time to prevent
unwanted side effects from happening.
If your doctor recommends it, make sure you use a method of contraception to prevent
pregnancy during your treatment. Tell your doctor if you become pregnant while you
are receiving this medicine.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are having Octreotide Depot.
Tell any other doctor, dentist or pharmacist who treats you that you are having Octreotide
Depot.
Things you must not do
Do not give your medicine to anyone else, even if their symptoms seem to be the same
as yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert
until you know how Octreotide Depot affects you.
This medicine may cause dizziness, light-headedness or weakness in some people. If
you have any of these symptoms, do not drive or do anything else that could be dangerous.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are having Octreotide Depot.
All medicines can cause side effects. Sometimes they are serious, but most of the
time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately if you notice:
signs of allergy such as rash, itching or hives on the skin; swelling of the face,
lips, tongue or other part of the body; shortness of breath, wheezing or troubled
breathing
severe pain, tenderness or swelling in the stomach or abdomen, which may be accompanied
by fever, nausea and vomiting, yellowing of the skin and eyes, loss of appetite, generally
feeling unwell, itching, light coloured urine (symptoms of a possible problem with
your liver, pancreas or gall bladder)
symptoms of low blood glucose (hypoglycaemia), including sweating, trembling, dizziness,
weakness, hunger, palpitations (feeling of fast or irregular heartbeat) and fatigue
symptoms of high blood glucose (hyperglycaemia), including lethargy or tiredness,
headache, thirst, passing large amounts of urine, and blurred vision
symptoms of changes in the activity of the thyroid gland (hyper or hypothyroidism)
including changes in heart rate, appetites or weight, tiredness, feeling cold or sweating
too much, anxiety or swelling at the front of the neck.
unusually slow or fast heartbeat.
thirst, low urine output, dark urine, dry flushed skin
increased bleeding or bruising (could be low level of platelets in blood).
Tell your doctor if you notice any of the following side effects and they worry you:
pain, irritation, redness, rash or swelling at the injection site
loss of appetite
indigestion, nausea or vomiting
cramps
feeling of bloating or wind
constipation, diarrhoea or other change in bowel motions
abdominal pain
headache
temporary hair loss
changes in the rhythm of your heartbeat
shortness of breath
weakness
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may happen in some people.
After using Octreotide Depot
Storage
If you have to store Octreotide Depot at home:
Keep the vials in the original container until it is time to use them.
If you are storing the vials for longer than one day, keep them in the refrigerator
at 2°C to 8°C. Do not freeze them.
You can remove Octreotide Depot from the fridge and store it below 25°C on the day
of injection but it must be kept in the original outer carton to protect it from light.
The suspension must only be prepared immediately prior to injection.
Octreotide Depot carton contents should reach room temperature (20°C to 25°C) before
preparation. A minimum of 30 minutes is required.
If any vials have been left out of the fridge for longer than one day (24 hours),
do not use them.
The reconstituted suspension contains no preservative.
This medicine is for single use in one patient only.
Discard any residue.
Keep the medicine where children cannot reach it.
Disposal
If your doctor stops your treatment with this medicine or the expiry date has passed
or the vials have been left out of the fridge for too long, ask your pharmacist what
to do with any medicine you have left over.
Product description
What it looks like
Octreotide Depot is a white to white with yellowish tint powder packed in a glass
vial. The diluent is a clear, colourless to slightly yellow or brown solution. Each
box of Octreotide Depot contains one vial of powder, a glass syringe of diluent to
mix with the powder, a vial adaptor and safety injection needle.
Ingredients
Octreotide Depot vials contain 10 mg, 20 mg or 30 mg of the active ingredient octreotide
(as acetate). They also contain:
mannitol
polyglactin
The solution in the syringe contains:
carmellose sodium
mannitol
poloxamer
water for injections
Sponsor
Octreotide Depot is supplied in Australia by:
Teva Pharma Australia Pty Ltd
37 Epping Road
Macquarie Park NSW 2113
AUSTRALIA
Teva Pharma (New Zealand) Ltd
Level 14, 41 Shortland Street
Auckland 1010
NEW ZEALAND
This leaflet was prepared in September 2024.
Australian Registration Numbers
Octreotide Depot 10 mg vial
AUST R 321280
Octreotide Depot 20 mg vial
AUST R 321282
Octreotide Depot 30 mg vial
AUST R 321281