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SANDOSTATIN LAR 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance(s): OCTREOTIDE ACETATE

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Package leaflet: Information for the patient

SANDOSTATIN LAR 10 mg powder and
solvent for suspension for injection
SANDOSTATIN LAR 20 mg powder and
solvent for suspension for injection
SANDOSTATIN LAR 30 mg powder and
solvent for suspension for injection
octreotide
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor, pharmacist or
nurse.
–– This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
–– If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Sandostatin LAR is and what it is used for
2. What you need to know before you use Sandostatin LAR
3. How to use Sandostatin LAR
4. Possible side effects
5. How to store Sandostatin LAR
6. Contents of the pack and other information

1. What Sandostatin LAR is and what it is used for

Sandostatin LAR is a synthetic compound derived from somatostatin.
Somatostatin is normally found in the human body, where it inhibits
the release of certain hormones such as growth hormone. The
advantages of Sandostatin LAR over somatostatin are that it is
stronger and its effects last longer.

Sandostatin LAR is used
• to treat acromegaly,
Acromegaly is a condition where the body produces too much growth
hormone. Normally, growth hormone controls growth of tissues,
organs, and bones. Too much growth hormone leads to an increase in
the size of bones and tissues, especially in the hands and feet.
Sandostatin LAR markedly reduces the symptoms of acromegaly,
which include headache, excessive perspiration, numbness of the
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 treatment may
reduce the size of the adenoma.
Sandostatin LAR is used to treat people with acromegaly:
–– 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.
• to relieve symptoms associated with overproduction of some
specific hormones and other related substances by 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.
• to treat neuroendocrine tumours located in the gut (e.g. appendix,
small intestine or colon)
Neuroendocrine tumours are rare tumours which can be found in
different parts of the body. Sandostatin LAR is also used to control
the growth of these tumours, when they are located in the gut
(e.g. appendix, small intestine or colon).
• to treat pituitary tumours 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 tumours that produce too much thyroid‑stimulating hormone
(TSH):
–– when other types of treatment (surgery or radiotherapy) are not
suitable or have not worked;
–– after radiotherapy, to cover the interim period until the
radiotherapy becomes fully effective.

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

Follow all instructions given to you by your doctor carefully. They may
differ from the information contained in this leaflet.

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Brewery House,
The Maltings,
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HU1 3HA
Tel: +44 (0) 1482 973000

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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 precautions
Talk to your doctor before using Sandostatin LAR:
–– if you know that you have gallstones now, or have had them in
the past; tell your doctor, as prolonged use of Sandostatin LAR
may result in gallstone formation. Your doctor may wish to check
your gallbladder periodically.
–– if you know that you have diabetes, as Sandostatin LAR can affect
blood sugar levels. If you are diabetic, your sugar levels should be
checked regularly.
–– if you have a history of vitamin B12 deprivation your doctor may
wish to check your vitamin B12 level periodically.
Test and checks
If you receive treatment with Sandostatin LAR over a long period of
time, your doctor may wish to check your thyroid function
periodically.
Your doctor will check your liver function.
Children
There is little experience with the use of Sandostatin LAR in children.
Other medicines and Sandostatin LAR
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
You can generally continue taking other medicines while on
Sandostatin LAR. However, certain medicines, such as cimetidine,
ciclosporin, bromocriptine, quinidine and terfenadine have been
reported to be affected by Sandostatin LAR.
If you are taking a medicine to control your 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 dosage.
If you are diabetic, your doctor may need to adjust your insulin
dosage.
Pregnancy and breast‑feeding
If you are pregnant or breast‑feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before taking
this medicine.
Sandostatin LAR should only be used during pregnancy if clearly
needed.
Women of child‑bearing age should use an effective contraceptive
method during treatment.

Do not breast-feed while using Sandostatin LAR. It is not known
whether Sandostatin LAR passes into breast milk.

Instructions for preparation and intramuscular injection for
Sandostatin LAR

Driving and using machines
Sandostatin LAR has no or negligible effects on the ability to drive
and use machines. However, some of the side effects you may
experience while using Sandostatin LAR, such as headache and
tiredness, may reduce your ability to drive and use machines safely.

FOR DEEP INTRAMUSCULAR INJECTION ONLY
Included in the injection kit:

Sandostatin LAR contains sodium
Sandostatin LAR contains less than 1 mmol sodium (23 mg) per
dose, which means it is essentially “sodium-free”.

If you use more Sandostatin LAR than you should
No life‑threatening reactions have been reported after overdose of
Sandostatin LAR.
The symptoms of overdose are: hot flushes, frequent urination,
tiredness, depression, anxiety and lack of concentration.
If you think that an overdose has happened and you experience such
symptoms, tell your doctor straight away.
If you forget to use Sandostatin LAR
If your injection is forgotten, it is recommended that you are given it
as soon as it is remembered, and then continue as usual. 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.
If you stop using Sandostatin LAR
If you interrupt your treatment with Sandostatin LAR your symptoms
may come back. Therefore, do not stop using 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 straight away if
you get any of the following:
Very common (may affect more than 1 in 10 people):
• Gallstones, causing sudden back pain.
• Too much sugar in the blood.

• Remove the lid film of the vial adapter
packaging, but do NOT remove the vial
adapter from its packaging.
• Holding the vial adapter packaging,
position the vial adapter on top of the vial
and push it fully down so that it snaps in
place, confirmed by an audible “click.”

3. How to use Sandostatin LAR

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

Step 2
• Remove the plastic cap from the vial
and clean the rubber stopper of the vial
with an alcohol wipe.

a. One vial containing Sandostatin LAR powder,
b. One prefilled syringe containing the vehicle solution for reconstitution,
c. One vial adapter for drug product reconstitution,
d. One safety injection needle.
Follow the instructions below carefully to ensure proper reconstitution
of Sandostatin LAR before deep intramuscular injection.
There are 3 critical actions in the reconstitution of Sandostatin LAR. Not
following them could result in failure to deliver the drug appropriately.
• The injection kit must reach room temperature. Remove the
injection kit from the fridge and let the kit stand at room
temperature for a minimum of 30 minutes before reconstitution,
but do not exceed 24 hours.
• After adding the diluent solution, ensure that the powder is fully
saturated by letting the vial stand for 5 minutes.
• After saturation, shake the vial moderately in a horizontal direction
for a minimum of 30 seconds until a uniform suspension is formed.
The Sandostatin LAR suspension must only be prepared
immediately before administration.
Sandostatin LAR should only be administered by a trained healthcare
professional.
Step 1
• Remove the Sandostatin LAR injection
kit from refrigerated storage.
ATTENTION: It is essential to start the
reconstitution process only after the
injection kit reaches room temperature. Let
the kit stand at room temperature for a
minimum of 30 minutes before
reconstitution, but do not exceed 24 hours.
Note: The injection kit can be re-refrigerated
if needed.

• Lift the packaging off the vial adapter
with a vertical movement.

Step 3
• Remove the cap from the syringe
prefilled with diluent solution and
screw the syringe onto the vial adapter.
• Slowly push the plunger all the way
down to transfer all the diluent solution
in the vial.

Step 4
ATTENTION: It is essential to let the vial
stand for 5 minutes to ensure that the
diluent has fully saturated the
powder.
Note: It is normal if the plunger rod moves
up as there might be a slight overpressure
in the vial.
• At this stage prepare the patient for
injection.

2184238 GB

03/03/2016 14:33

The Maltings

Comp. Number New: 2184238 GB
Comp. Number Old: 2161102 GB
Format/Dimension: 594 x 210 mm
Tech. Drawing No.: 799.4.9167/06

Read the following explanations before you use Sandostatin LAR.

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Step 8
• Sandostatin LAR must be given only by
deep intramuscular injection, NEVER
intravenously.
• Insert the needle fully into the left or
right gluteus at a 90º angle to the skin.
• Slowly pull back the plunger to check
that no blood vessel has been
penetrated (reposition if a blood vessel
has been penetrated).
• Depress the plunger with steady
pressure until the syringe is empty.
Withdraw the needle from the injection
site
and activate the safety guard (as shown
in Step 9).

Step 5
• After the saturation period, make sure
that the plunger is pushed all the way
down in the syringe.
ATTENTION: Keep the plunger pressed and
shake the vial moderately in a horizontal
direction for a minimum of 30 seconds so
that the powder is completely suspended
(milky uniform suspension). Repeat
moderate shaking for another 30 seconds
if the powder is not completely suspended.
Step 6
• Turn syringe and vial upside down,
slowly pull the plunger back and draw
the entire contents from the vial into
the syringe.

Step 9
• Activate the safety guard over the
needle in one of the two methods
shown:
–– either press the hinged section of
the safety guard down onto a hard
surface (figure A)
–– or push the hinge forward with
your finger (figure B).

• Unscrew the syringe from the vial
adapter.

Step 7
• Screw the safety injection needle onto
the syringe.

• An audible “click” confirms the proper
activation.

• If immediate administration is delayed,
gently re-shake the syringe to ensure a
milky uniform suspension
• Prepare injection site with an
alcohol wipe.
• Pull the protective cover straight off the
needle.
• Gently tap the syringe to remove any
visible bubbles and expel them from
the syringe.
• Proceed immediately to Step 8 for
administration to the patient. Any delay
may result in sedimentation.

• Dispose of syringe immediately (in a
sharps container).

Other serious side effects
• Hypersensitivity (allergic) reactions including skin rash.
• A type of an allergic reaction (anaphylaxis) which causes difficulty
in breathing or dizziness.
• An inflammation of the pancreas gland (pancreatitis); symptoms
may include sudden pain in the upper abdomen, nausea,
vomiting, diarrhoea.
• Liver inflammation (hepatitis); symptoms may include yellowing
of the skin and eyes (jaundice), nausea, vomiting, loss of appetite,
generally feeling unwell, itching, light‑coloured urine.
• Irregular heart beat.
Tell your doctor straight away if you notice any of the side effects above.
Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the side
effects listed below. They are usually mild and tend to disappear as
treatment progresses.

Common (may affect up to 1 in 10 people):
• Stomach discomfort after meal (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Loose stools.
• Discolouration of faeces.

• Dizziness.
• Loss of appetite.
• Change in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.
If you get any side effects, please tell your doctor, nurse or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Sandostatin LAR

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Sandostatin LAR may 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
label and carton after EXP. The expiry date refers to the last day of
that month.
Do not use this medicine if you notice particles or a change of colour.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Sandostatin LAR contains
–– The active substance is octreotide
One vial contains 10 mg, 20 mg or 30 mg octreotide
(as octreotide acetate)
–– The other ingredients are
in powder (vial): poly(DL-lactide-co-glycolide) and mannitol (E421).
in solvent (prefilled syringe): carmellose sodium, mannitol (E421),
poloxamer 188, water for injections
What Sandostatin LAR looks like and contents of the pack
Unit packs containing one 6 mL glass vial with rubber stopper
(bromobutyl rubber), sealed with an aluminium flip-off seal,

containing powder for suspension for injection and one 3 mL
colourless pre-filled glass syringe with front and plunger stopper
(chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed
blister tray with one vial adapter and one safety injection needle.

(GH concentrations still above 2.5 microgram/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 a dose of 30 mg,
the dose may be increased to 40 mg every 4 weeks.

Multipacks of three unit packs, each unit pack containing: one 6 mL
glass vial with rubber stopper (bromobutyl rubber), sealed with an
aluminium flip-off seal, containing powder for suspension for injection
and one 3 mL colourless pre-filled glass syringe with front and plunger
stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed
blister tray with one vial adapter and one safety injection needle.

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

Not all strengths and pack sizes may be marketed in your country.
This medicinal product is authorised in the Member States of the
EEA under the following names:
Sandostatin LAR
Austria, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland,
Germany, Greece, Hungary, Ireland, Iceland,
Latvia, Lithuania, Malta, Norway, Poland,
Romania, Slovakia, Slovenia, Spain, Sweden,
United Kingdom
Belgium, Luxemburg, Netherlands
Sandostatine LAR
Italy, Portugal
Sandostatina LAR
France
Sandostatine L.P.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England.
This leaflet was last revised in 03/2016.
If you would like any more information, or would like the leaflet in a
different format, please contact Medical Information at Novartis
Pharmaceuticals UK Ltd, telephone number 01276 698370.
SANDOSTATIN is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited
The following information is intended for healthcare professionals only:
How much Sandostatin LAR to use
Acromegaly
It is recommended to start treatment with the administration of
20 mg Sandostatin LAR at 4-week intervals for 3 months. Patients on
treatment with s.c. Sandostatin can start treatment with Sandostatin
LAR the day after the last dose of s.c. Sandostatin. Subsequent
dosage adjustment should be based on serum growth hormone (GH)
and insulin-like growth factor‑1/somatomedin C (IGF‑1)
concentrations and clinical symptoms.
For patients in whom, within this 3-month period, clinical symptoms
and biochemical parameters (GH; IGF‑1) are not fully controlled

For patients on a stable dose of Sandostatin LAR, assessment of GH
and IGF‑1 should be made every 6 months.
Gastro‑entero‑pancreatic endocrine tumours
• Treatment of patients with symptoms associated with functional
gastro-entero-pancreatic neuroendocrine tumours
It is recommended to start treatment with the administration of
20 mg Sandostatin LAR at 4-week intervals. Patients on treatment
with s.c. Sandostatin should continue at the previously effective
dosage for 2 weeks after the first injection of Sandostatin LAR.
For patients in whom symptoms and biological markers are well
controlled after 3 months of treatment, the dose may be reduced to
10 mg 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
Sandostatin LAR every 4 weeks.
For days when symptoms associated with gastro-entero-pancreatic
tumours may increase during treatment with Sandostatin LAR,
additional administration of s.c. Sandostatin is recommended at the
dose used prior to the Sandostatin LAR treatment. This may occur
mainly in the first 2 months of treatment until therapeutic
concentrations of octreotide are reached.
• Treatment of patients with advanced Neuroendocrine Tumours of
the midgut or of unknown origin where non-midgut sites of origin
have been excluded
The recommended dose of Sandostatin LAR is 30 mg administered
every 4 weeks. Treatment with Sandostatin LAR for tumour control
should be continued in the absence of tumour progression.
Treatment of TSH-secreting adenomas
Treatment with Sandostatin LAR should be started at a dose of
20 mg at 4-weekly intervals for 3 months before considering dose
adjustment. The dose is then adjusted on the basis of the TSH and
thyroid hormone response.

2184238 GB

03/03/2016 14:33

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1485863
Comp. Description: Leaflet SANDOSTATIN LAR MPVI GB

Both

Production Site:
CTM:
Printing Colours:

PANTONE 314 C

Technical Colours: Cutting
Dimensions

Minimum Font Size: 9.0pt
Font Type: News Gothic
Proof Number: 2
Braille:

Uncommon (may affect up to 1 in 100 people):
• Thirst, low urine output, dark urine, dry flushed skin.
• Fast heart beat.

Very common (may affect more than 1 in 10 people):
• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence (wind).
• Headache.
• Local pain at the injection site.

2184238_GB_p2_LFT.indd 2

Comp. Number New: 2184238 GB
Comp. Number Old: 2161102 GB
Format/Dimension: 594 x 210 mm
Tech. Drawing No.: 799.4.9167/06

Common (may affect up to 1 in 10 people):
• Underactive thyroid gland (hypothyroidism) causing changes in
heart rate, appetite or weight; tiredness, feeling cold, or swelling
at 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.
• Impaired glucose tolerance.
• Slow heart beat.

03/03/2016

! P LEASE TU R N OV E R P R I N T I N G O N !
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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