Caelyx pegylated liposomal
Authorised
This medicine is authorised for use in the European Union
doxorubicin
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Caelyx pegylated liposomal can only be obtained with a prescription. It should only be given under the supervision of a doctor who is qualified in the use of cytotoxic (cell-killing) medicines. It cannot be interchanged with other medicines that contain doxorubicin.
The dose of Caelyx pegylated liposomal depends on the condition it is used for and is calculated on the basis of the patient’s weight and height. The doctor may stop treatment or reduce the dose if certain side effects occur or if the patient has liver problems.
For more information about using Caelyx pegylated liposomal, see the package leaflet or contact your doctor or pharmacist.
Doxorubicin, the active substance in Caelyx pegylated liposomal, is a cytotoxic medicine that belongs to the group ‘anthracyclines’. It interferes with the DNA in cells, preventing them from making more copies of DNA and making proteins. This means that cancer cells cannot divide and eventually die. Caelyx pegylated liposomal builds up in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Doxorubicin has been available since the 1960s. In Caelyx pegylated liposomal, it is enclosed in ‘pegylated liposomes’ (tiny fat particles coated with a substance called polyethylene glycol). This slows down removal of the medicine, allowing it to circulate in the blood for longer. It also reduces its effects on healthy tissues and cells, so it is less likely to cause some side effects.
Caelyx pegylated liposomal has been studied in a total of 2,512 patients in seven main studies.
For metastatic breast cancer, in a study involving 509 women, Caelyx pegylated liposomal was as effective as standard doxorubicin: the time until the disease got worse was around 7.5 months in both groups. However, patients receiving Caelyx pegylated liposomal were less likely to have heart problems.
For advanced ovarian cancer, in a study involving 474 women who had received platinum-based chemotherapy in the past, Caelyx pegylated liposomal was as effective as topotecan (another cancer medicine) in extending time until the disease got worse.
For AIDS-related Kaposi’s sarcoma, the effectiveness of Caelyx pegylated liposomal was studied in two studies involving 384 patients, including 77 who had received treatment before. Around 70% of the patients had a complete or partial response to treatment, with similar results in the study of patients who had been treated before. In additional studies involving a total of 499 patients, Caelyx pegylated liposomal was more effective than either a combination of standard doxorubicin, bleomycin and vincristine (other cancer medicines) or a combination of bleomycin and vincristine.
For multiple myeloma, in a study involving 646 patients, the time until the disease got worse with a Caelyx pegylated liposomal and bortezomib was 9.3 months compared with 6.5 months in patients treated with bortezomib alone.
The side effects with Caelyx pegylated liposomal depend on the type of cancer being treated. The most common side effect with Caelyx pegylated liposomal (which may affect more than 1 in 10 people) is nausea (feeling sick). Other very common side effects include palmar-plantar erythrodysaesthesia syndrome (redness and pain on the hands and feet), vomiting, stomatitis (inflammation of the lining of the mouth), rash, weakness, low blood cell counts, loss of appetite, hair loss, tiredness, diarrhoea, constipation and mucositis (inflammation of the mouth and throat).
Caelyx pegylated liposomal must not be used to treat Kaposi’s sarcoma that could be treated effectively with ‘local’ treatments that only affect the site of the tumour or with alfa interferon treatment.
For the full list of side effects and restrictions of Caelyx pegylated liposomal, see the package leaflet.
The European Medicines Agency decided that Caelyx pegylated liposomal’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Caelyx pegylated liposomal have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Caelyx pegylated liposomal are continuously monitored. Side effects reported with Caelyx pegylated liposomal are carefully evaluated and any necessary action taken to protect patients.
Caelyx pegylated liposomal received a marketing authorisation valid throughout the EU on 21 June 1996.
Product information
Latest procedure affecting product information:
PSUSA/00001172/202211
25/08/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Caelyx pegylated liposomal
- Active substance
- doxorubicin hydrochloride
- International non-proprietary name (INN) or common name
- doxorubicin
- Therapeutic area (MeSH)
- Sarcoma, Kaposi
- Multiple Myeloma
- Ovarian Neoplasms
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01DB
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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).
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