GRANOCYTE 34 lenograstim 263 micrograms powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Lenograstim

Available from:

Pfizer Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

________________________________________________________________________________
GRANOCYTE
page
1
GRANOCYTE

Lenograstim_ (len-o-GRA-stim)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GRANOCYTE. 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 being given GRANOCYTE
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE._ _
You may need to read it again.
WHAT GRANOCYTE IS
USED FOR
GRANOCYTE is a synthetic (man-
made) version of a substance called
granulocyte colony-stimulating factor
(G-CSF) which is produced naturally
by the human body.
G-CSF is produced by certain cells
within the bone marrow to stimulate
the production of neutrophils (a type of
white blood cell). Neutrophils help the
body to prevent or fight infection. A
low neutrophil level increases your risk
of infection. GRANOCYTE is
therefore used to (help) increase the
neutrophil count in those with low
white blood cell counts, a condition
known as neutropenia.
A low number of neutrophils in your
blood (neutrophil count) often occurs
after bone marrow transplantation or
chemotherapy. On rare occasions,
infants have a low neutrophil count
present at birth (congenital
neutropenia).
Stem Cell Transplantation
Some chemotherapy drugs have toxic
effects on the bone marrow. Your
doctor may collect stem cells (the
parent cells of all blood cells) from
your blood before you have
chemotherapy.
There are normally only a small
number of stem cells in the blood.
GRANOCYTE can be used to increase
the number of stem cells in the blood.
The stem cells are then collected by a
procedure, called leukapheresis, done
in hospital.
The stem cells collected from the blood
are stored until after you have had your
chemotherapy. They are then given
ba

Summary of Product characteristics

Version: pfpgranv10521
Supersedes pfpgranv10320
Page 1 of 21
AUSTRALIAN
PRODUCT
INFORMATION
–
GRANOCYTE
® (LENOGRASTIM)
1.
NAME OF THE MEDICINE
Lenograstim
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GRANOCYTE
contains lenograstim, a recombinant glycoprotein equivalent to the
human
granulocyte colony stimulating factor (G-CSF).
GRANOCYTE
13 contains 105 µg (13.4 million International Units

) (IU) lenograstim in 1 mL
of reconstituted product.
GRANOCYTE
34 contains 263 µg (33.6 million International Units

) (IU) lenograstim in 1 mL
of reconstituted product.
The
reconstituted
product
for
both
strengths
of
GRANOCYTE
is
formulated
with
a
hydrochloric
acid
buffer
at
pH
6.5
and
contains
2.5%
mannitol,
1%
arginine,
1%
phenylalanine, 0.1% methionine and 0.01% polysorbate 20.
EXCIPIENT(S) WITH KNOWN EFFECT
Phenylalanine
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
GRANOCYTE
is presented as white cake of lyophilised powder for injection in a
glass vial
with a rubber stopper and a flip off cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GRANOCYTE is indicated
•
to reduce the duration of neutropenia and the severity of infections
in patients with non-
myeloid malignancy who have either undergone autologous or allogeneic
bone marrow
transplantation or undergone treatment with established cytotoxic
chemotherapy.


as measured by the GNFS-60
_in vitro _
bioassay in comparison with the WHO International
Standard for human
G-CSF)
Version: pfpgranv10521
Supersedes pfpgranv10320
Page 2 of 21
•
to reduce the incidence of infection associated with established
cytotoxic chemotherapy.
•
to mobilise peripheral blood progenitor cells (PBPCs) either with
GRANOCYTE alone,
or after myelosuppressive chemotherapy, in order to accelerate
haematopoietic recovery
by infusion of such cells, after myelosuppressive or myeloablative
therapy in patients with
non-myeloid malignancies. GRANOCYTE is also indicated to accelerate
the engraftment
of these cells after their rein