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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

octreotide, Quantity: 50 microgram

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; glacial acetic acid; sodium acetate trihydrate

Administration route:

Subcutaneous

Units in package:

5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Clear colourless solution free from visible particulates; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-04-01

Patient Information leaflet

OCTREOTIDE SUN CMI V3
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:
1.
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.
2.
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.
3.
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 substa

Summary of Product characteristics

Page
1
of
9
OCTEOTRIDE SUN PI V5
AUSTRALIAN PRODUCT INFORMATION
OCTREOTIDE SUN
OCTREOTIDE SOLUTION FOR INJECTION
1 NAME OF THE MEDICINE
Octreotide (as acetate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (as
octreotide acetate).
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
ACROMEGALY
Initially 0.05-0.1 mg by subcutaneous injection every 8 or 12 hours.
Dosage adjustment should be based on monthly
assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; IGF-1 within
normal range) and on clinical symptoms,
and on tolerability. In most patients the optimal daily dose will be
0.2 to 0.3 mg. A maximum dose of 1.5 mg per day
should not be exceeded. For patients on a stable dose of octreotide,
assessment of biochemical markers should be
made periodically.
If no relevant reduction of GH levels and no improvement of clinical
symptoms have been achieved within three
months of starting treatment with octreotide, therapy should be
discontinued.
GASTRO-ENTERO-PANCREATIC ENDOCRINE TUMOURS
Initially 0.05 mg once or twice