SIGNIFOR pasireotide 900 microgram/1 mL (as diaspartate) solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pasireotide diaspartate, Quantity: 1128.6 microgram (Equivalent: pasireotide, Qty 900 microgram)

Available from:

Recordati Rare Diseases Australia Pty Ltd

INN (International Name):

pasireotide diaspartate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; water for injections; sodium hydroxide; tartaric acid

Administration route:

Subcutaneous

Units in package:

60 (10 packs of 6) ampoules, 6 x 1 mL ampoules, 30 (5 packs of 6) ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of adult patients with Cushing?s disease for whom surgery is not an option or for whom surgery has failed.

Product summary:

Visual Identification: Clear colourless solution in a 1 mL colourless glass ampoule with one point cut, two blue and one red coloured rings; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-11-01

Patient Information leaflet

SIGNIFOR
®
1
SIGNIFOR
®
pasireotide
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Signifor.
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 taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SIGNIFOR IS USED
FOR
Signifor is used to treat Cushing's
Disease, a condition caused by an
enlargement in the pituitary gland
(pituitary adenoma, a benign tumour)
which produces too much of a
hormone called adrenocorticotropic
hormone (ACTH). This
overproduction of ACTH causes the
body to produce too much of another
hormone called cortisol. Too much
cortisol leads to a variety of signs
and symptoms such as weight gain
with abdominal obesity, moon-
shaped face, easy bruising, menstrual
abnormalities, excessive body and
facial hair, muscle wasting with
generalized weakness and tiredness,
depression and decreased libido.
Signifor is designed to block the
production of ACTH and therefore
cortisol and help to reduce the
symptoms caused by excess of
cortisol.
Signifor contains pasireotide, a
synthetic substance that mimics the
action of somatostatin, a substance
normally found in the human body,
which can block the production of
certain hormones such as ACTH. The
advantage of pasireotide over
somatostatin is that its effect is
stronger and lasts longer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTI

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SIGNIFOR
® (PASIREOTIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Pasireotide (as diaspartate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 mL contains:

300 microgram pasireotide (as diaspartate)

600 microgram pasireotide (as diaspartate)

900 microgram pasireotide (as diaspartate)
Pasireotide 300 micrograms/1 mL, 600 micrograms/1 mL and 900
micrograms/1 mL solution for
injection is clear and colourless.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The treatment of adult patients with Cushing’s disease for whom
surgery is not an option or for
whom surgery has failed.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage range of SIGNIFOR is 300 mcg to 900 mcg by
subcutaneous injection,
twice a day. The recommended initial dose is 600 mcg or 900 mcg twice
a day. Titrate dose based on
response and tolerability.
For patients who are started on 600 mcg twice a day, a dosage increase
to 900 mcg twice a day may
be considered based on the response to the treatment as long as the
600 mcg dosage is well
tolerated by the patient. Individualised dose reduction may be
considered for patients with a stable
response at the discretion of the treating physician.
Patients should be evaluated for treatment response (clinically
meaningful reduction in Urinary Free
Cortisol (UFC) levels and/or improvement in signs or symptoms of the
disease) and should continue
receiving therapy with Signifor as long as benefit is derived. Maximum
urinary free cortisol
reduction is typically seen by two months of treatment. Patients who
do not experience clinical
benefit from Signifor should be considered for discontinuation.
2
Management of suspected adverse reactions may require temporary dose
reduction of Signifor.
Dose reduction by decrements of 300 mcg twice a day is suggested.
If a dose of Signifor is missed, the next injection should be
admin