PLERIXAFOR ARX plerixafor 24 mg/1.2 mL solution for injection vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

plerixafor, Quantity: 24 mg

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, solution

Σύνθεση:

Excipient Ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections

Οδός χορήγησης:

Subcutaneous

Μονάδες σε πακέτο:

Single

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Plerixafor ARX is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (MM).

Περίληψη προϊόντος:

Visual Identification: Clear, colourless to pale yellow solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-08-12

Φύλλο οδηγιών χρήσης

Plerixafor
ARX
CMI Ver 0.5
1
PLERIXAFOR ARX
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Plerixafor ARX.
It does not contain all the
available information about
Plerixafor ARX.
It does not take the place of
talking to your doctor or trained
health care professional.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Plerixafor
ARX against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT IT IS USED FOR
Plerixafor is a targeted and
reversible blocker of a receptor
which is present on many cells in
the body, but particularly blood
stem cells. Blood stem cells are
the cells which give rise to all the
cells in your blood – red cells
which carry oxygen from the
lungs to the tissues; white cells
which fight infections, and
platelets which stop bleeding. In
the case of blood stem cells, this
receptor "ties" the blood stem
cells to the bone marrow.
If this "tie" is broken, the stem
cells will float out into the blood
flowing in your blood vessels
(arteries and veins) where they
can then be collected by a process
called apheresis. Apheresis
involves the insertion of a tube
into a vein. Blood is then sucked
out into a machine which collects
the cells wanted (in your case the
stem cells) and the unneeded cells
are returned back into your veins.
HOW IT WORKS
Plerixafor ARX is used to
improve the release or
"mobilisation" of blood stem cells
into your blood stream; allowing
their collection by apheresis,
following which they will be
frozen and stored until they are
transplanted back to you when
you need them to regenerate your
bone marrow and blood.
In studies which have been
carried out with Plerixafor ARX,
it was used with G-CSF
(granulocyte-colony stimulating
factor), another medicine which is
used to mobilise stem cells into
the bloodstream.
There is limited experience with
Plerixafor ARX in children.

Αρχείο Π.Χ.Π.

PLERIXAFOR PI Ver 1.0
1
AUSTRALIAN PRODUCT INFORMATION –PLERIXAFOR ARX (PLERIXAFOR)
1.
NAME OF THE MEDICINE
Plerixafor
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Plerixafor is an antagonist of the CXCR4 chemokine receptor.
Plerixafor is a white to off-white
crystalline solid.
Plerixafor ARX solution for injection is supplied as a clear,
colourless to pale yellow sterile,
preservative-free, isotonic solution. Each single-use vial contains 24
mg plerixafor.
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Plerixafor ARX solution for injection is supplied in a 2.0 mL clear
glass (Type I) vial, sealed
with a rubber stopper and aluminium flip-off seal.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plerixafor ARX is indicated in combination with granulocyte-colony
stimulating factor
(G-CSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral
blood for collection
and subsequent autologous transplantation in patients with lymphoma
and multiple myeloma
(MM).
4.2 DOSE AND METHOD OF ADMINISTRATION
Plerixafor ARX therapy should be initiated and supervised by a
physician experienced in
oncology and/or haematology. Plerixafor ARX therapy should be
administered by a nurse,
physician, or other health care professional.
Begin treatment with Plerixafor ARX after the patient has received
G-CSF once daily for
4 days. The recommended dose of Plerixafor ARX is 0.24 mg/kg body
weight by subcutaneous
(SC) injection. Plerixafor ARX should be administered 6 to 11 hours
prior to initiation of
apheresis. In clinical trials, subcutaneous administration to the
abdomen was recommended;
however, some patients received SC injections in the extremities.
G-CSF should be continued
each morning prior to apheresis.
Plerixafor has been commonly used for 2 to 4 consecutive days. It has
been used for up to 7
consecutive days in a clinical setting.
The patient’s actual body weight will be used to calculate the
volume of Plerixafor ARX to be
administered. Each vial delivers 1.2 mL of 20 mg/mL