What is Caelyx?
Caelyx is a concentrate for the preparation of a solution for infusion (drip into a vein). The active ingredient in Caelyx is doxorubicin hydrochloride (2 mg / ml).
What is Caelyx used for?
Caelyx is used to treat the following types of cancer:
- metastatic breast cancer in patients at risk of heart problems; "metastatic" means that the cancer has spread to other parts of the body. For this indication Caelyx is used alone;
- advanced ovarian cancer in patients previously treated with platinum-based anticancer drugs that no longer have effect;
- Kaposi's sarcoma (cancer of the blood vessels) in patients with AIDS (acquired immunodeficiency syndrome) with severely compromised immune system and extended sarcoma of the skin, wet parts of the body or internal organs. It is used if other treatments no longer have effect or are not tolerated;
- multiple myeloma (cancer of bone marrow cells) in patients with progressive disease previously subjected to at least one other treatment and not suitable for bone marrow transplantation. Caelyx is used in combination with bortezomib (another anticancer medicine).
The medicine can only be obtained with a prescription.
How is Caelyx used?
Caelyx is given under the supervision of a qualified doctor in the use of cytotoxic drugs (which kill cells) and is not interchangeable with other medicines containing doxorubicin hydrochloride.
The recommended starting dose of Caelyx for breast or ovarian cancer is 50 mg per square meter of body surface area (calculated based on the patient's height and weight) every four weeks until the disease worsens and the patient tolerates treatment. For Kaposi's sarcoma, the dose is 20 mg / m2 every 2-3 weeks for 2-3 months; for multiple myeloma it is 30 mg / m2 to be administered on the fourth day of each three-week cycle of bortezomib treatment, until the patient shows benefits and tolerates the drug.
Treatment should be stopped or the dose reduced if certain side effects occur or liver problems occur. Caelyx is not recommended for patients undergoing spleen removal and for children. For more information, see the package leaflet.
How does Caelyx work?
The active ingredient contained in Caelyx, doxorubicin hydrochloride, is a cytotoxic drug belonging to the anthracyclines that acts by acting on the internal DNA of the cells, preventing DNA replication and protein production. Thus the cancer cells cannot divide and end up dying. Caelyx accumulates in areas of the body where the blood vessels have an abnormal shape, such as inside tumors, and its action is concentrated there.
Doxorubicin hydrochloride has been available since the 1960s. In Caelyx this active ingredient is contained in "pegylated liposomes" (small spheres containing fats coated with a chemical substance, polyethylene glycol), so as to decrease the rate of decomposition of the active ingredient and prolong its circulation time in the blood. This also reduces the effects of the drug on healthy tissues and cells, thus reducing the likelihood of some side effects.
What studies have been performed on Caelyx?
Caelyx has been the subject of seven main studies involving a total of 2512 patients.
For metastatic breast cancer, Caelyx was compared with normal doxorubicin in a main study involving 509 female patients.
For advanced stage ovarian cancer, Caelyx was compared with topotecan (another anticancer medicine) in a study of 474 female patients who had previously undergone platinum chemotherapy.
For AIDS-related Kaposi's sarcoma, the efficacy of Caelyx has been the subject of two main studies involving 384 patients, of which 77 have already been treated. Further studies compared Caelyx with a combination of doxorubicin, bleomycin and vincristine (other anticancer drugs) on 258 patients and with a combination of bleomycin and vincristine on 241 patients.
For multiple myeloma the efficacy of the Caelyx-bortezomib combination was compared with that of bortezomib monotherapy in 646 patients.
The main measure of effectiveness was the time until the disease got worse or, in the case of Kaposi's sarcoma, the number of patients who responded to treatment.
What benefit has Caelyx shown during the studies?
In the treatment of breast cancer Caelyx showed an efficacy equal to that of normal doxorubicin; the time until the disease worsened was approximately 7.5 months in both groups. However, patients treated with Caelyx were less likely to report heart problems.
Regarding ovarian cancer, Caelyx has proven to be the topotecan in delaying the worsening of the disease.
For Kaposi's sarcoma, about 70% of patients showed a complete or partial response to treatment, with results similar to those obtained in the study of patients already treated. The other studies showed that Caelyx was also more effective than the comparison combinations.
For multiple myeloma, the addition of Caelyx to bortezomib delayed the worsening of the disease from 6.5 to 9.3 months.
What is the risk associated with Caelyx?
The side effects associated with Caelyx depend on the type of cancer being treated. The most common side effect (in more than 1 patient in 10) seen in all types of cancer is nausea. Other very common side effects are palmar-plantar erythrodysaesthesia (redness and pain in the hands and feet), vomiting, stomatitis (inflammation of the epithelial lining of the mouth), rash, asthenia (weakness), low blood cell count, anorexia ( loss of appetite), alopecia (hair loss), fatigue, diarrhea, constipation and mucositis (inflammation of the mouth and throat). For the full list of all side effects reported with Caelyx, see the Package Leaflet.
Caelyx should not be used in patients who may be hypersensitive (allergic) to doxorubicin hydrochloride or any of the other ingredients. Caelyx should not be used to treat Kaposi's sarcoma if it is treatable effectively with localized treatments (affecting only the tumor site) or systemic alpha-interferon treatment (which affects the whole organism).
Why has Caelyx been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Caelyx are greater than its risks in the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma (in combination with bortezomib) and of Kaposi sarcoma related to AIDS and therefore recommended the granting of marketing authorization for Caelyx.
More information on Caelyx
On 21 June 1996, the European Commission issued a marketing authorization for Caelyx, valid throughout the European Union, to SP Europe. This authorization was renewed on June 21, 2001 and June 21, 2006.
The full EPAR for Caelyx can be found here.
Last update of this summary: 02-2008.
