Caelyx pegylated liposomal
doxorubicin
Table of contents
Overview
Caelyx pegylated liposomal is a medicine used to treat the following types of cancer in adults:
- metastatic breast cancer in patients at risk of heart problems. ‘Metastatic’ means the cancer has spread to other parts of the body. Caelyx pegylated liposomal is used on its own for this disease;
- advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;
- Kaposi’s sarcoma in patients with AIDS who have very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs;
- multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had a bone marrow transplantation or are unsuitable for it. Caelyx pegylated liposomal is used in combination with bortezomib (another cancer medicine).
Caelyx pegylated liposomal contains the active substance doxorubicin.
Authorisation details
Product details | |
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Name |
Caelyx pegylated liposomal
|
Agency product number |
EMEA/H/C/000089
|
Active substance |
doxorubicin hydrochloride
|
International non-proprietary name (INN) or common name |
doxorubicin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01DB
|
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
|
Revision |
32
|
Date of issue of marketing authorisation valid throughout the European Union |
20/06/1996
|
Contact address |
Turnhoutseweg 30 |
Product information
18/01/2021 Caelyx pegylated liposomal - EMEA/H/C/000089 - II/0094
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Caelyx pegylated liposomal is indicated:
- as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk;
- for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;
- 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;
- for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.
Caelyx pegylated liposomal 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 standarddoxorubicin (or other anthracycline).