Caelyx pegylated liposomal

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.