OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection vial plus diluent prefilled syringe composite pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
octreotide
Available from:
Teva Pharma Australia Pty Ltd
Authorization status:
Registered
Authorization number:
321280

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Octreotide Depot

®

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 take 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 take 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 start to take 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

OCTREOTIDE DEPOT - NOVEMBER 2020 - V1.0

problems with your blood

pressure

problems with your thyroid

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 start taking

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 taking

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.

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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.

OCTREOTIDE DEPOT - NOVEMBER 2020 - V1.0

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

November 2020.

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

OCTREOTIDE DEPOT - NOVEMBER 2020 - V1.0

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Teva Pharma Australia Pty Limited

Version 2

AUSTRALIAN PRODUCT INFORMATION – OCTREOTIDE DEPOT

(OCTREOTIDE) MODIFIED RELEASE INJECTION

1

NAME OF THE MEDICINE

Octreotide.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection plus diluent

OCTREOTIDE DEPOT octreotide (as acetate) 20 mg modified release injection plus diluent

OCTREOTIDE DEPOT octreotide (as acetate) 30 mg modified release injection plus diluent

For the full list of excipients, see Section 6.1 List of excipients.

3

PHARMACEUTICAL FORM

Modified release, injection

Octreotide Depot is a modified release injection of octreotide. The octreotide is

distributed within polymer microspheres. The powder is a white to white with yellowish

tint.

Diluent

The vehicle is a clear, colourless to slightly yellow or brown solution. The pH of the

reconstituted suspension is 5-8.

Single glass vials of 10, 20 or 30 mg octreotide modified release injection to be

suspended in 2 mL diluent prior to injection.

4

CLINICAL PARTICULARS

4.1

T

HERAPEUTIC INDICATIONS

Acromegaly

For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients

with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or

dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide.

Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in

the interim period until radiotherapy becomes fully effective.

Gastro-entero-pancreatic tumours

For the relief of symptoms associated with the following functional tumours of the gastro-entero-

pancreatic endocrine system:

Carcinoid tumours with features of the carcinoid syndrome

Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately

controlled on subcutaneous treatment with octreotide

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Octreotide Depot is not curative in these patients.

Advanced Neuroendocrine Tumours of the Midgut

Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of

the midgut or suspected midgut origin.

4.2

D

OSE AND METHOD OF ADMINISTRATION

Octreotide Depot may only be administered by deep intragluteal injection. Each injection

is for single use only. The site of repeat intragluteal injections should be alternated

between the left and right gluteal muscle. Deltoid injections are to be avoided because of

significant discomfort at the injection site when given in that area.

Acromegaly

Patients controlled with subcutaneous octreotide

In patients who are adequately controlled with the usual therapeutic range of

subcutaneous octreotide, it is recommended to start treatment with the administration of

20 mg Octreotide Depot at 4-week intervals for 3 months. Treatment with Octreotide

Depot can be started the day after the last dose of s.c. octreotide. Subsequent dosage

adjustment should be based on serum GH and IGF- 1 concentrations and clinical

symptoms.

In patients in whom clinical symptoms and biochemical parameters (GH; IGF-1) are

not fully controlled (GH concentrations still above 2.5 µg/L) within this 3-month

period, the dose may be increased to 30 mg every 4 weeks.

The monitoring of GH concentrations is recommended for another 3 months. If, after 6

months of treatment, the response is judged to be inadequate from clinical and

biological points of view, Octreotide Depot should be discontinued.

For patients whose GH concentrations are consistently below 1 µg/L, whose IGF-1 serum

concentrations are normalised, and in whom most reversible signs/symptoms of acromegaly have

disappeared after 3 months of treatment with 20 mg, 10 mg of Octreotide Depot 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, as well as clinical

signs/symptoms at this low dose of Octreotide Depot.

For patients on a stable dose of Octreotide Depot, assessment of biochemical markers should be

made periodically.

Patients not previously treated with octreotide

For patients in whom surgery, radiotherapy or dopamine agonist treatment is inappropriate, or

ineffective, or in the interim period until radiotherapy becomes fully effective, a short treatment

period of subcutaneous octreotide is recommended to assess the response and systemic tolerability

of octreotide prior to initiating treatment with Octreotide Depot as described above.

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Gastro-entero-pancreatic endocrine tumours

Patients controlled with subcutaneous octreotide

For patients whose symptoms are adequately controlled with s.c. octreotide, it is recommended to

start treatment with the administration of 20 mg Octreotide Depot at 4-week intervals. The

treatment with s.c. octreotide should be continued at the previously effective dosage for 2 weeks

after the first injection of Octreotide Depot.

For patients in whom symptoms and biological markers are well controlled after 3 months of

treatment, the dose may be reduced to 10 mg Octreotide Depot every 4 weeks. For patients whose

symptoms are only partially controlled after 3 months of treatment, the dose may be increased to

30 mg Octreotide Depot every 4 weeks.

For days when symptoms associated with gastro-entero-pancreatic tumours may increase during

treatment with Octreotide Depot, additional administration of s.c. octreotide is recommended at the

dose used prior to the Octreotide Depot treatment. This may occur mainly in the first 2 months of

treatment until therapeutic concentrations of octreotide are reached.

Patients not previously treated with octreotide

For patients who were not previously treated with s.c. octreotide, it is recommended to start with

the administration of s.c. octreotide at a dosage of 0.1 mg (100 micrograms) three times daily for a

short period (approximately 2 weeks) to assess the response and systemic tolerability of octreotide

before initiating the treatment with Octreotide Depot as described above.

Advanced neuroendocrine tumours of the midgut or suspected midgut origin

The recommended dose of Octreotide Depot is 30 mg administered every 4 weeks. Treatment with

Octreotide Depot for tumour control should be continued in the absence of tumour progression.

Instructions for preparation and intramuscular injection for Octreotide Depot

Procedure Kit with vial adapter and safety needle

FOR DEEP INTRAGLUTEAL INJECTION ONLY

The reconstituted suspension contains no preservative. This medicine is for single use in one patient

only. Discard any residue.

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Version 2

Content:

One vial containing Octreotide Depot powder,

One prefilled syringe containing the vehicle solution for reconstitution,

One vial adapter for drug product reconstitution,

One safety injection needle.

Follow the instructions below carefully to ensure proper reconstitution of Octreotide Depot before

deep intragluteal injection.

There are 3 critical actions in the reconstitution of Octreotide Depot. 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 Octreotide Depot suspension must

only be prepared immediately before administration.

Octreotide Depot should only be administered by a trained health professional.

Step 1

Remove the Octreotide Depot 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.

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Step 2

Remove the plastic cap from the vial and clean

the rubber stopper of the vial with an alcohol

wipe.

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.”

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.

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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.

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

Prepare injection site with an alcohol wipe.

Turn syringe and vial upside down, slowly pull

the plunger back and draw the entire contents

from the vial into the syringe.

Unscrew the syringe from the vial adapter.

Step 7

Screw the safety injection needle onto the

syringe.

Gently re-shake the syringe to ensure a milky

uniform suspension.

Pull the protective cover straight off the needle.

Gently tap the syringe to remove any visible

bubbles and expel them from the syringe.

Verify that injection site has not been

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contaminated.

Proceed immediately to Step 8 for

administration to the patient. Any delay may

result in sedimentation

Step 8

Octreotide Depot must be given only by deep

intragluteal 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 9

Activate the safety guard over the needle in

one of the 2 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).

An audible “click” confirms the proper

activation.

Dispose of syringe immediately (in a sharps

container).

4.3

C

ONTRAINDICATIONS

Hypersensitivity to octreotide or any components of the formulation.

4.4

S

PECIAL WARNINGS AND PRECAUTIONS FOR USE

Cardiovascular related events

Cases of bradycardia have been reported (frequency: common). Medical review including dose

adjustment of this agent and dose adjustments of drugs such as beta-blockers, calcium channel

blockers, or agents to control fluid and electrolyte balance, may be necessary.

Gallbladder and related events

Cholelithiasis is a very common event during octreotide treatment and may be associated with

cholecystitis and biliary duct dilatation (see Section 4.8 Adverse effects (Undesirable Effects)).

Additionally, cases of cholangitis have been reported as a complication of cholelithiasis in patients

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taking octreotide modified release injection in the post-marketing setting. Ultrasonic examination of

the gallbladder before and at 6 to 12 monthly intervals during Octreotide Depot therapy is

recommended.

GH secreting pituitary tumours

As GH-secreting pituitary tumours may sometimes expand, causing serious complication (e.g. visual

field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion

appears, alternative procedures may be advisable.

Gastro-entero-pancreatic tumours

In the treatment of gastro-entero-pancreatic endocrine tumours with subcutaneous octreotide ,

sudden escape from symptomatic control may occur infrequently, with rapid recurrence of severe

symptoms. To date, in patients with gastro-entero-pancreatic endocrine tumours treated with

Octreotide Depot, there is no evidence of a sudden escape from symptomatic control with abrupt

recurrence of severe symptoms.

Effects on glucose regulation

In patients with concomitant Type I diabetes mellitus, Octreotide Depot is likely to affect glucose

regulation, and insulin requirements may be reduced. In non-diabetics and type II diabetics with

partially intact insulin reserves, octreotide s.c. administration may result in increases in post-

prandial glycaemia. It is therefore recommended to monitor glucose tolerance and antidiabetic

treatment.

In patients with concomitant hypersecretion of insulin, octreotide, because of its greater relative

potency in inhibiting the secretion of GH and glucagon than that of insulin, and because of the

shorter duration of its inhibitory action on insulin, may increase the depth and prolong the duration

of hypoglycaemia. These patients should be closely monitored.

Nutrition

Octreotide may alter absorption of dietary fats in some patients.

Depressed vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients

receiving octreotide therapy. Monitoring of vitamin B12 levels is recommended during therapy with

Octreotide Depot in patients who have a history of vitamin B12 deprivation.

Thyroid function

Thyroid function should be monitored in patients receiving prolonged treatment with octreotide.

Use in hepatic impairment

In a study with octreotide administered subcutaneously and intravenously it was shown that the

elimination capacity was reduced in patients with liver cirrhosis, but not in patients with fatty liver

disease. Due to the wide therapeutic window of octreotide, no dose adjustment of Octreotide Depot

is necessary in patients with liver cirrhosis.

Use in renal impairment

Impaired renal function did not affect the total exposure (AUC) to octreotide when administered

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subcutaneously. Therefore, no dose adjustment of Octreotide Depot is necessary.

Use in the elderly

In a study with octreotide administered subcutaneously no dose adjustment was necessary in

patients 65 years of age or older. Therefore, no dose adjustment is necessary in this group of

patients with Octreotide Depot.

Paediatric use

There is very limited experience with the use of Octreotide Depot in children.

Effects on laboratory tests

See Section 4.4 Special warnings and precautions for use, Nutrition.

4.5

I

NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS

Dose adjustment of medicinal products such as beta-blockers, calcium channel blockers, or agents to

control fluid and electrolyte balance, may be necessary when Octreotide Depot is administered

concomitantly (see Section 4.4 Special warnings and precautions for use).

Octreotide has been found to reduce the intestinal absorption of cyclosporin and to delay that of

cimetidine. Since octreotide has also been associated with alterations in nutrient absorption, its

effect on absorption of any orally administered drugs should be carefully considered.

Adjustment of the dosage of drugs affecting glucose metabolism, such as insulin and oral

hypoglycaemic agents, may be required during Octreotide Depot therapy.

Concomitant administration of octreotide and bromocriptine increased the bioavailability of

bromocriptine.

Limited published data indicate that somatostatin analogues might decrease the metabolic

clearance of compounds known to be metabolised by cytochrome P450 enzymes, which may be due

to the suppression of growth hormone. Since it cannot be excluded that octreotide may have this

effect, other drugs mainly metabolised by CYP3A4 and which have a low therapeutic index (e.g.

quinidine) should therefore be used with caution.

4.6

F

ERTILITY

,

PREGNANCY AND LACTATION

Effects on fertility

It is not known whether octroetide has an effect on human fertility. Reproduction studies have been

performed in rats and rabbits at doses up to 1 mg/kg octreotide and have revealed no evidence of

any adverse effect of subcutaneous octreotide on fertility or morphogenesis (see Section 4.6,

Fertility, Pregnancy and Lactation, Use in Pregnancy).

Use in pregnancy – Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. In the post-marketing

experience, data on a limited number of exposed pregnancies have been reported in patients with

acromegaly, however, in half of the cases the pregnancy outcomes are unknown. Most women were

exposed to octreotide during the first trimester of pregnancy at doses ranging from 100 to

300 micrograms/day of octreotide s.c. or 20 to 30 mg/month of Octreotide Depot. In approximately

Teva Pharma Australia Pty Limited

Version 2

two- thirds of the cases with known outcome, the women elected to continue octreotide therapy

during their pregnancies. In most of the cases with known outcome, normal newborns were

reported but also several spontaneous abortions during the first trimester, and a few induced

abortions.

There were no cases of congenital anomalies or malformations due to octreotide usage in the cases

that reported pregnancy outcomes.

Octreotide should only be prescribed to pregnant women under compelling circumstances.

The therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-

like growth factor 1 (IGF-1) concentration in female acromegalic patients could potentially restore

fertility. Female patients of childbearing potential should be advised to use adequate contraception

if necessary during treatment with octreotide.

Reproduction studies have been performed in rats and rabbits at doses up to 1 mg/kg octreotide and

have revealed no evidence of any adverse effect of subcutaneous octreotide on fertility or

morphogenesis. Foetal and post natal growth retardation was seen in rats, probably due to

suppression of growth hormone.

Use in lactation.

It is unknown whether octreotide is excreted in human breast milk. Animal studies have shown

excretion of octreotide in breast milk. Patients should not breast-feed during octreotide treatment.

4.7

E

FFECTS ON ABILITY TO DRIVE AND USE MACHINES

The effects of this medicine on a person's ability to drive and use machines were not assessed as

part of its registration.

4.8

A

DVERSE EFFECTS

(U

NDESIRABLE EFFECTS

)

Summary of the safety Profile

The most frequent adverse reactions reported during octreotide therapy include gastrointestinal

disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional

disorders.

The most commonly reported adverse reactions in clinical trials with octreotide administration were

diarrhoea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycaemia and

constipation. Other commonly reported adverse reactions were dizziness, localised pain, biliary

sludge, thyroid dysfunction (e.g. decreased thyroid stimulating hormone [TSH], decreased Total T4,

and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and

hypoglycaemia.

Tabulated summary of adverse drug reactions from clinical trials

Adverse drug reactions (see Table 1 below) from clinical trials are listed by MedDRA system organ

class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the

most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented

in order of decreasing seriousness. In addition, the corresponding frequency category for each

adverse drug reaction is based on the following convention (CIOMS III): very common (≥ 1/10);

common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare

(< 1/10,000).

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Public Summary

Summary for ARTG Entry:

321280

OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection vial plus diluent prefilled

syringe composite pack

ARTG entry for

Medicine Registered

Sponsor

Teva Pharma Australia Pty Ltd

Postal Address

Locked Bag 2053, NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

25/11/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under

Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or

Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1 . OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection vial plus diluent prefilled

syringe composite pack

Product Type

Composite Pack

Effective Date

25/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Acromegaly

For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately

controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide.

Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully

effective.,Gastro-entero-pancreatic tumours

For the relief of symptoms associated with the following functional tumours of the gastro-enteropancreatic

endocrine system:

· Carcinoid tumours with features of the carcinoid syndrome

· Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide

Octreotide Depot is not curative in these patients.,Advanced Neuroendocrine Tumours of the Midgut

Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Child resistant closure

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 8 mL vial of powder with 1 x 2 mL vial pre-filled syringe of diluent

(S4) Prescription Only Medicine

Components

1 . Vial containing powder for injection

Public Summary

Page 1 of

Produced at 13.01.2021 at 04:36:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Dosage Form

Injection, modified release

Route of Administration

Intramuscular

Visual Identification

The powder is a white to white with yellowish tint.

Active Ingredients

octreotide

10 mg

Other Ingredients (Excipients)

mannitol

polyglactin

2 . Diluent in pre-filled syringe with safety needle

Dosage Form

Injection, diluent for

Route of Administration

Intramuscular

Visual Identification

The vehicle is a clear, colourless to slightly yellow or brown solution.

Other Ingredients (Excipients)

carmellose sodium

mannitol

poloxamer

water for injections

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 13.01.2021 at 04:36:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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