LIPODOX LIPOSOMAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01DB01

Pharmaceutical form:

LIPOSOME CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOXORUBICIN HYDROCHLORIDE 2 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

TARO INTERNATIONAL LTD, ISRAEL

Therapeutic area:

DOXORUBICIN

Therapeutic indications:

1. First or second line therapy of AIDS related Kaposis sarcoma in patients with low CD 4 counts and extensive mucocutaneous or visceral disease. 2. The treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel and platinium-based chemotherapy regimens and who may also be refractory to topotecan. Refractory is defined as a patient having progressive disease while on treatment or within 6 months of completing treatment. 3. As monotherapy for patients with metastatic breast cancer where there is an increased cardiac risk. 4. In combination with bortezomib for the treatment of progressive multiplemyeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

Authorization date:

2019-10-06

Summary of Product characteristics

Page 1 of 20
LIPODOX
® LIPOSOMAL
1.
NAME OF THE MEDICINAL PRODUCT
Lipodox Liposomal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Lipodox Liposomal contains 2 mg doxorubicin hydrochloride in
a pegylated liposomal formulation.
Lipodox Liposomal, a liposome formulation, is doxorubicin
hydrochloride encapsulated in liposomes with surface
bound
methoxypolyethylene glycol (MPEG). This process is known as pegylation
and protects liposomes from
detection by the
mononuclear phagocyte system (MPS), which increases blood circulation
time.
Excipients with known effect
Contains fully hydrogenated soy phosphatidylcholine (from soyabean)
– see section 4.3.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liposome concentrate for solution for infusion
The suspension is sterile, translucent and red
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lipodox Liposomal is indicated:
-
First or second line therapy of AIDS-related Kaposi’s sarcoma (KS)
in patients with low CD4 counts and
extensive mucocutaneous or
visceral disease.
-
The treatment of patients with metastatic carcinoma of the ovary who
are refractory to both paclitaxel and
platinium based
chemotherapy regimens and who may also be refractory to topotecan.
Refractory is defined
as a patient having progressive
disease while on treatment, or within 6 months of completing
treatment.
-
As monotherapy for patients with metastatic breast cancer, where there
is an increased cardiac risk.
-
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lipodox Liposomal should only be administered under the supervision of
a qualified oncologist specialized in
the administration of
cytotoxic agents.
Lipodox Liposomal exhibits unique pharmacokinetic properties and must
not be used interchangeably with
other non-liposomal formulations of
doxorubicin hyd