What is DepoCyte?
DepoCyte is a suspension for injection containing 50 mg of the active substance cytarabine.
What is DepoCyte used for?
DepoCyte is used in the treatment of lymphomatous meningitis, a disease in which lymph node tumor cells spread to the spinal fluid, to the membranes that cover the brain and spinal cord (the meninges). DepoCyte helps control the symptoms of the disease. The medicine can only be obtained with a prescription.
How is DepoCyte used?
Treatment with DepoCyte should only be started by a doctor experienced in administering anticancer medicines. The administration takes place via a "deposit" injection (a type of injection in which the drug is prepared so that it is absorbed very slowly by the body). The medicine must be injected directly into the spinal fluid (intrathecal injection: puncture in the space surrounding the spinal cord and the brain). At the same time, a steroid (dexamethasone) should also be given to the patient to control some of the side effects of the drug.
DepoCyte is initially given as a 50 mg injection every two weeks for the first five doses, followed by another 50 mg dose four weeks later, and then by four 50 mg maintenance doses every four weeks. The dosage can be reduced to 25 mg if the patient shows symptoms of neurotoxicity (headache, abnormal vision, or weakness or muscle pain).
How does DepoCyte work?
The active ingredient in DepoCyte, cytarabine (also known as ara-C), is an anti-tumor agent used since the 1970s. It is a cytotoxic drug (a substance that kills active dividing cells, such as cancer cells) belonging to the group of antimetabolites.
Cytarabine is an analogue of pyrimidine. Pyrimidine is a component of the genetic material of cells (DNA and RNA). In the body, cytarabine replaces pyrimidine and interferes with enzymes involved in DNA synthesis. In this way, cytarabine inhibits the growth of tumor cells until it is destroyed. In DepoCyte, cytarabine is present in a special formulation: the active ingredient, that is, is contained in liposomes (small fat particles), from which it is slowly released.
How has DepoCyte been studied?
The effects of DepoCyte were first analyzed in experimental models before being studied in humans. The main study was carried out on 35 patients and compared the intrathecal administration of DepoCyte to a standard cytarabine formulation. The study measured the response of patients to treatment (absence of tumor cells in the spinal fludo) and the worsening of the nervous disorders of which they are affected (nervous system symptoms).
What benefit has DepoCyte shown during the studies?
13 of the 18 patients treated with DepoCyte responded to the treatment, causing tumor cell removal from the spinal fluid, while among the 17 patients who received the standard formulation, only 3 responded to treatment. However, no difference was recorded between the two drugs with regard to the length of the remission period, at the end of which patients experienced a worsening of nervous disorders.
What is the risk associated with DepoCyte?
The most common side effects (observed in percentages ranging from 10 to 25% of treatment cycles) are headache, nausea, vomiting, fever and back pain. Moreover DepoCyte can favor the onset of arachnoiditis (inflammation of the arachnoid, one of the membranes that protect the spine and the brain). In order to minimize the side effects to patients, placed under close medical observation, a steroid (oral or an injection) should be administered at the time of DepoCyte injection. For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
DepoCyte should not be used in people who may be hypersensitive (allergic) to cytarabine or any of the other substances. The drug should not be given to patients with an active infection of the meninges.
Why has DepoCyte been approved?
The Committee for Medicinal Products for Human Use (CHMP) has found DepoCyte to be effective in the treatment of lymphomatous meningitis compared to the standard formulation of the citabirin and that the administration program, with less intrathecal injections, can improve the quality of life. of patients. The CHMP decided that DepoCyte's benefits are greater than its risks and therefore recommended that it be given marketing authorization.
More information on DepoCyte:
On 11 July 2001, the European Commission issued a marketing authorization for DepoCyte, valid throughout the European Union. The authorization was renewed on 11 July 2006. The marketing authorization holder is Pacira Limited.
For the full version of DepoCyte Epar click here.
Last update of this summary: July 2007
