Celdoxome pegylated liposomal
Authorised
This medicine is authorised for use in the European Union
doxorubicin hydrochloride
MedicineHumanAuthorised
Overview
Celdoxome 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. Celdoxome 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 previous treatment and have already had a bone marrow transplantation or are unsuitable for it. Celdoxome pegylated liposomal is used in combination with bortezomib (another cancer medicine).
Celdoxome pegylated liposomal contains the active substance doxorubicin.
Celdoxome pegylated liposomal is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but in Celdoxome pegylated liposomal the active substance is enclosed in ‘pegylated liposomes’ (tiny fat particles coated with a substance called polyethylene glycol) while this is not the case for the reference medicine. The reference medicine for Celdoxome pegylated liposomal is Adriamycin.
Celdoxome 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) cancer medicines. It cannot be interchanged with other medicines that contain doxorubicin.
Celdoxome pegylated liposomal is given as an infusion (drip) into a vein. The dose depends on the condition it is used for and the patient’s liver function, and is calculated on the basis of the patient’s weight and height. The duration of treatment depends on the condition being treated. The doctor may stop treatment or reduce the dose if certain side effects occur.
For more information about using Celdoxome pegylated liposomal, see the package leaflet or contact your doctor or pharmacist.
Doxorubicin, the active substance in Celdoxome pegylated liposomal, is a cytotoxic medicine that belongs to a group of medicines called ‘anthracyclines’. It interferes with the DNA in cancer cells, preventing them from making more copies of DNA and making proteins. This means that cancer cells cannot divide and eventually die. Celdoxome pegylated liposomal builds up in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where the medicine’s action is concentrated.
Doxorubicin has been available since the 1960s. In Celdoxome 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.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Adriamycin, and do not all need to be repeated for Celdoxome pegylated liposomal. However, since Adriamycin contains doxorubicin in a different form (not enclosed in pegylated liposomes), the company also presented results from a study in patients with metastatic breast cancer to show that Celdoxome pegylated liposomal is bioequivalent to Caelyx pegylated liposomal, another authorised medicine that contains doxorubicin in pegylated liposomal form. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
The most common side effects with Celdoxome pegylated liposomal (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), leucopenia (low levels of white blood cells), anaemia (low levels of red blood cells) and tiredness.
The most common serious side effects (which may occur in more than 1 in 50 people) are neutropenia, leucopenia, lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia, thrombocytopenia (low levels of blood platelets), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome; rash and numbness on the palms and soles), stomatitis (inflammation of the lining of the mouth), tiredness, diarrhoea, vomiting, nausea, fever, dyspnoea (difficulty breathing), and pneumonia (infection of the lungs).
Celdoxome 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 that affects the whole body. Celdoxome pegylated liposomal must not be used in people allergic to peanut or soya.
For the full list of side effects and restrictions of Celdoxome pegylated liposomal, see the package leaflet.
The European Medicines Agency concluded that, in accordance with EU requirements, Celdoxome pegylated liposomal has been shown to be comparable to the reference medicine Adriamycin and bioequivalent to Caelyx pegylated liposomal. Therefore, the Agency decided that the benefits of Celdoxome pegylated liposomal 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 Celdoxome pegylated liposomal have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Celdoxome pegylated liposomal are continuously monitored. Suspected side effects reported with Celdoxome pegylated liposomal are carefully evaluated and any necessary action taken to protect patients.
Celdoxome pegylated liposomal received a marketing authorisation valid throughout the EU on 15 September 2022.
Product information
Latest procedure affecting product information: H/C/005330/T/0004
21/03/2024
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
- Celdoxome pegylated liposomal
- Active substance
- doxorubicin hydrochloride
- International non-proprietary name (INN) or common name
- doxorubicin hydrochloride
- Therapeutic area (MeSH)
- Breast Neoplasms
- Ovarian Neoplasms
- Multiple Myeloma
- Sarcoma, Kaposi
- Anatomical therapeutic chemical (ATC) code
- L01DB01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Celdoxome pegylated liposomal is indicated in adults:
- as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
- or 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.
Celdoxome 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 standard doxorubicin (or other anthracycline).
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