LIPOSOMAL DOXORUBICIN SUN Doxorubicin Hydrochloride 50mg/25mL Liposome Injection concentrate glass vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxorubicin hydrochloride, Quantity: 2 mg/mL

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Doxorubicin hydrochloride

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; sucrose; histidine; cholesterol; sodium methoxy PEG-40-carbonyl-distearoylphosphatidylethanolamine; hydrogenated soy phosphatidylcholine; ammonium sulfate; ethanol; water for injections

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LIPOSOMAL DOXORUBICIN SUN, as monotherapy, is indicated for the treatment of metastatic breast cancer.,LIPOSOMAL DOXORUBICIN SUN is also indicated for the treatment of:,? Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,LIPOSOMAL DOXORUBICIN SUN may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline).,LIPOSOMAL DOXORUBICIN SUN is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

Product summary:

Visual Identification: Translucent, red colored liposomal suspension.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-12-11

Patient Information leaflet

LIPOSOMAL DOXORUBICIN SUN CMI V3
Page 1 of 5
LIPOSOMAL DOXORUBICIN SUN
_Pegylated liposomal Liposomal Doxorubicin hydrochloride_
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_CONSUMER MEDICINE INFORMATION_
_ _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Liposomal Doxorubicin SUN. 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
Liposomal Doxorubicin SUN against the benefits
it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN
THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IS LIPOSOMAL DOXORUBICIN
SUN USED FOR
Liposomal Doxorubicin SUN is used to treat
cancer of the breast and ovary. It is used to kill
cancer. Other symptoms of Kaposi's sarcoma,
such as swelling around the tumour, may also
improve or disappear.
Liposomal Doxorubicin SUN belongs to a group
of medicines called antineoplastic or cytotoxic
medicines. You may also hear of these being
called chemotherapy medicines.
Liposomal Doxorubicin SUN contains a
medicine called Liposomal Doxorubicin
hydrochloride which is able to interact with cells
in such a way as to selectively kill cancer cells.
The Liposomal Doxorubicin hydrochloride in
Liposomal Doxorubicin SUN is enclosed in tiny
spheres called liposomes which help to deliver
the medicine from the blood stream to the
cancerous tissue rather than healthy normal
tissue.
Your doctor, however, may prescribe Liposomal
Doxorubicin SUN for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT WHY LIPOSOMAL DOXORUBICIN SUN HAS
BEEN PRESCRIBED FOR YOU.
cancer cells, shrink the size and delay the growth
of the tumour.
Liposomal Doxorubicin SUN is also used in
combination with another medicine called
bortezomib to treat multiple myeloma, which is a
cancer of the plasma cell. Plasma cells are
produced in the bone marrow and are a
component of the immune system.
Liposomal Doxorubic

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LIPOSOMAL DOXORUBICIN SUN (DOXORUBICIN HYDROCHLORIDE)
INJECTION
1
NAME OF THE MEDICINE
liposomal doxorubicin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liposomal Doxorubicin SUN, a pegylated liposomal formulation of
doxorubicin hydrochloride,
contains doxorubicin encapsulated in liposomes having surface-bound
methoxypolyethylene glycol
groups (pegylated liposomes). This process is known as pegylation and
protects the liposomes from
detection by the mononuclear phagocyte system (MPS), which increases
blood circulation time.
Each vial contains 20 mg or 50 mg doxorubicin hydrochloride (HCl) at a
concentration of 2.0 mg/ml
in a pegylated liposomal formulation.
The drug substance, doxorubicin hydrochloride is an orange-red
crystalline powder. It is soluble in
water, slightly soluble in methanol and practically insoluble in
ethanol and acetone.
3
PHARMACEUTICAL FORM
Liposomal Doxorubicin SUN is a concentrate for infusion presented as a
sterile, translucent, red
suspension in glass vials containing 10 ml or 25 ml for single-use
intravenous infusion. The pH of the
suspension is 6.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Liposomal Doxorubicin SUN, as monotherapy, is indicated for the
treatment of metastatic breast
cancer.
Liposomal Doxorubicin SUN is also indicated for the treatment of:
•
Advanced epithelial ovarian cancer in women who have failed a
first-line platinum-based
chemotherapy regimen.
•
AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts
(<200
lymphocytes/mm
3
) and extensive mucocutaneous or visceral disease.
Liposomal Doxorubicin SUN may be used as first-line systemic
chemotherapy, or as second line
chemotherapy in AIDS-KS patients with disease that has progressed
with, or in patients intolerant to,
prior combination systemic chemotherapy comprising at least two of the
following agents: a vinca
alkaloid, bleomycin and doxorubicin (or other anthracycline).
2
Liposomal Doxorubicin SUN is also indicated, in combination with
bortezom