OCTREOTIDE SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule

Main information

  • Trade name:
  • OCTREOTIDE SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OCTREOTIDE SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184895
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184895

OCTREOTIDE SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

19/07/2012

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 SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

26/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

controlled by surgery, radiotherapy, or dopamine agonist treatment. Octreotide treatment is also indicated in acromegalic patients unfit or unwilling to

undergo surgery, or in the interim period until radiotherapy becomes fully effective.,? 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],Octreotide is not curative in these patients.,? For reduction of the incidence of complications following pancreatic surgery.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Refrigerate

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. OCTREOTIDE SUN octreotide (as acetate) 50 microgram/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear colourless solution free from visible particulates

Active Ingredients

Octreotide

50 microgram

© 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 1 of

Produced at 29.11.2017 at 04:00:42 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

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

OCTREOTIDE SUN CMI V2

Page 1 of 5

OCTREOTIDE SUN

Octreotide

CONSUMER HEALTH INFORMATION

What is in this leaflet

This leaflet answers some

common questions about

Octreotide SUN. The

information in this leaflet was

last updated on the date listed

on the final page. More recent

information on the medicine

may be available.

You should ensure that you

speak to your pharmacist or

doctor to obtain the most up

to date information on the

medicine.

Those updates may contain

important information about the

medicine and its use of which

you should be aware. 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 using Octreotide SUN

against the benefits they expect

it will have for you.

If you have any concerns

about using this medicine, ask

your doctor or pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again.

What Octreotide SUN

is used for

Octreotide SUN has three uses:

Octreotide SUN 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. This 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 SUN can relieve

many of these symptoms.

Octreotide SUN is used to

relieve symptoms of certain

types of cancer such as

carcinoid syndrome and

VIPoma.

By blocking hormones that are

over-produced in these

conditions, Octreotide SUN can

relieve symptoms such as

flushing of the skin and severe

diarrhoea.

Octreotide SUN is used for

people who are having

surgery on the pancreas. This

medicine helps to lower the

chance of complications after

the surgery.

Octreotide SUN contains

octreotide, a man-made

medicine derived from

somatostatin, a substance found

in the human body. Octreotide

is used instead of somatostatin

because its effects are stronger

and last longer so that it needs

to be given only 2 or 3 times a

day.

Ask your doctor if you have

any questions about why

Octreotide SUN has been

prescribed for you.

Your doctor may have

prescribed this medicine for

another reason.

This medicine is only available

with a doctor's prescription. It is

not addictive.

There is very little information

on the use of this medicine in

children.

Before you use

Octreotide SUN

When you must not use it

Do not use Octreotide SUN if

you have an allergy to:

octreotide (the active

ingredient in Octreotide

SUN) 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 use Octreotide SUN

after the expiry date printed

on the pack or if the

packaging is torn or shows

signs of tampering.

In that case, return it to your

pharmacist.

OCTREOTIDE SUN CMI V2

Page 2 of 5

Before you start to use it

Tell your doctor if you have,

or have had, any of the

following medical conditions:

gallstones

diabetes, as Octreotide SUN

can affect blood sugar levels.

If you are diabetic, your

sugar levels should be

checked regularly

problems with your liver

a history of vitamin B 12

deprivation

Your doctor may want to take

special precautions if you have

any of the above 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 intend to become

pregnant or wish to breast-

feed your baby.

There is not much information

on the use of Octreotide SUN

during pregnancy or breast-

feeding. If it is necessary for

you to use 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.

t is not known if

Octreotide SUN passes into

breast milk. Breastfeeding is not

recommended during treatment

with Octreotide SUN.

If you have not told your

doctor about any of these

things, tell him/her before you

use Octreotide SUN.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including any that you buy

without a prescription from a

pharmacy, supermarket or

health food shop.

Some medicines and Octreotide

SUN may interfere with each

other. Some of these medicines

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.

You may need to take 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 using Octreotide

SUN.

How to use Octreotide

SUN

Follow all directions given to

you by your doctor and

pharmacist carefully.

These directions may differ

from the information contained

in this leaflet.

If you do not understand the

instructions on the label, ask

your doctor or pharmacist for

help.

How it is given

Octreotide SUN cannot be taken

by mouth because it is rapidly

broken down in the stomach.

Instead it is given as a

subcutaneous injection. That

means that it is injected into the

fat layer just under the skin.

How much is given

The dose of Octreotide SUN

depends on the condition being

treated.

Acromegaly: treatment is

usually started with

injections of 0.05 to 0.1 mg

every 8 or 12 hours. The

dose can then be adjusted

depending on how well it

blocks growth hormone and

relieves symptoms such as

tiredness, sweating and

headache.

Carcinoid syndrome and

VIPoma: treatment is usually

started with injections of

0.05 mg once or twice a day.

The dose can be increased if

symptoms such as diarrhoea

are not relieved.

Surgery on the pancreas:

injections of 0.1 mg are

usually given three times a

day for one week, starting

about an hour before the

operation.

If you are giving the

injections yourself

If you will be giving the

injections yourself, your doctor

or nurse will teach you how to

do it properly.

Before using a Octreotide

SUN ampoule, check the

liquid for particles or a

OCTREOTIDE SUN CMI V2

Page 3 of 5

change in colour. If you notice

anything unusual, do not use

the ampoule.

Once an ampoule is opened,

use it immediately and throw

out any liquid that remains.

The ampoule does not contain

any preservative.

Give the injections between

meals or at bedtime. Avoid

having meals around the time

of the injections.

This will help to reduce the

chance of stomach upset.

To help prevent irritation or

pain at the injection site:

Choose a new site for each

injection. The upper arms,

thighs and abdomen are good

areas for injection.

Make sure the ampoule is at

room temperature before you

use it. If it has been in the

fridge, take it out half an

hour before using it. You can

warm it up in your hand but

don't try to heat it.

If you notice pain, stinging,

tingling, burning, redness or

swelling at the injection site

after the injection, gently rub

the site for a few seconds.

These side effects rarely last

more than 15 minutes after an

injection.

If you forget to use it

Inject the dose as soon as you

remember, and then go back

to using it as you would

normally.

It won't do any harm if you miss

a dose but some of your

symptoms may come back

temporarily until you get back

on schedule.

Do not use a double dose to

make up for the one that you

missed.

This may increase the chance of

you getting an unwanted side

effect.

If you have trouble

remembering when to use

your medicine, ask your

pharmacist for some hints.

If you use too much

(Overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26),

or go to Accident and

Emergency at your nearest

hospital if you think that an

overdose has happened. Do

this even if there are no signs

of discomfort or poisoning.

Some of the symptoms of an

overdose may include hot

flushes, fatigue, depression (sad

mood), anxiety, lack of

concentration and needing to

pass water more frequently than

usual.

No life-threatening reactions

have been reported after an

overdose of this medicine.

While you are using

Octreotide SUN

Things you must do

Keep all of your doctor's

appointments so that your

progress can be checked.

If you must use this medicine

for a long time, your doctor may

want to check your blood sugar,

gallbladder, thyroid and liver

functions 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 using Octreotide

SUN.

Tell any other doctor, dentist

or pharmacist who treats you

that you are using Octreotide

SUN.

Things you must not do

Do not give this 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

SUN 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.

OCTREOTIDE SUN CMI V2

Page 4 of 5

Side effects

Tell your doctor or

pharmacist as soon as possible

if you do not feel well while

you are using Octreotide SUN.

All medicines can have 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 this list

of possible 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

or go to Accident and

Emergency at your nearest

hospital if you notice:

signs of allergy such as rash,

itching or hives on the skin;

swelling of the face, lips,

tongue or other parts 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

unusually slow or fast

heartbeat

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

headache

dizziness or light headedness

swelling of hands or feet due

to excess fluid

tiredness or weakness

flushing of the skin

temporary hair loss

changes in the rhythm of

your heartbeat

shortness of breath

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.

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 SUN

Storage

Keep the ampoules in the

original container until it is

time to use them.

You can store the ampoules

for up to 2 weeks at room

temperature.

For longer than 2 weeks,

keep them in the refrigerator.

Do not freeze them.

Do not store Octreotide SUN

or any other medicine in the

bathroom or near a sink.

Do not leave them in the car

or on window sills.

Keep the medicine where

children cannot reach it.

Disposal

If any ampoules have been left

out of the fridge for longer

than 2 weeks, do not use them.

If your doctor tells you to stop

using this medicine or you

find that the expiry date has

passed or the ampoules 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 SUN comes in 1 mL

glass ampoules containing a

clear, colourless liquid; boxes of

OCTREOTIDE SUN CMI V2

Page 5 of 5

Ingredients

Octreotide SUN ampoules

contain 0.05 mg, 0.1 mg or 0.5

mg of the active ingredient,

octreotide (as octreotide

acetate). They also contain:

(S)-lactic acid

Mannitol

Sodium bicarbonate

Water for injection

Sponsor:

Ranbaxy Australia Pty Ltd

(A Sun Pharma Company)

Macquarie Park

Sydney NSW 2113

Australian registration

numbers:

Octreotide SUN 50

microgram/1mL (i.e.

0.05mg/1mL): 297815

Octreotide SUN 100

microgram/1mL (i.e. 0.1

mg/1mL): 297814

Octreotide SUN 500

microgram/1mL (i.e. 0.5

mg/1mL): 297813

This leaflet was last prepared in

January 2018.