DBL OCTREOTIDE INJECTION octreotide (as acetate) 0.5mg/1mL injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

octreotide

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Octreotide

Authorization status:

Registered

Patient Information leaflet

DBL™ OCTREOTIDE
INJECTION
_Octreotide (ok-tree-oh-tide) acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Octreotide
Injection. 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 DBL
Octreotide Injection 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.
You may need to read it again.
WHAT DBL OCTREOTIDE
INJECTION IS USED FOR
This medicine 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 can relieve many of
these symptoms.
•
SYMPTOMS OF CERTAIN TYPES OF
CANCER SUCH AS CARCINOID
SYNDROME AND VIPOMA:
By blocking hormones that are
over-produced in these
conditions, octreotide can relieve
symptoms such as flushing of the
skin and severe diarrhoea.
•
PEOPLE WHO ARE HAVING SURGERY
ON THE PANCREAS.
This medicine helps to lower the
chance of complications after the
surgery.
Octreotide is a man-made medicine
derived from somatostatin (so-MAT-
oh-STAT-in), 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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
There is very little information on the
use of this

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
OCTREOTIDE
INJECTION
(OCTREOTIDE
ACETATE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Octreotide acetate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Octreotide Injection contains octreotide (as acetate), a
synthetic octapeptide analogue
of somatostatin.
Each 1 mL vial contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (as
acetate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL™ Octreotide Injection is a clear colourless solution free of
foreign matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
For 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. 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:
o
Carcinoid tumours with features of the carcinoid syndrome
o
Vasoactive intestinal peptide secreting tumours (VIPomas).
Octreotide is not an antitumour therapy and is not curative in these
patients.
•
For reduction of the incidence of complications following pancreatic
surgery.
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4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
ACROMEGALY
Initially 0.05 to 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