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DepoCyte is a brand name for Cytarabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Verbatim from this product's EMA label. Tap a section to expand.
DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Posology Paediatric population Safety and efficacy in children aged under 18 years have not been established.
1 but no recommendation on a posology can be made. DepoCyte is not recommended for use in children and adolescents until further data become available. Adults and the elderly For the treatment of lymphomatous meningitis, the dose for adults is 50 mg (one vial) administered intrathecally (lumbar puncture or intraventricularly via an Ommaya reservoir).
The following regimen of induction, consolidation and maintenance therapy is recommended: Induction therapy: 50 mg administered every 14 days for 2 doses (weeks 1 and 3). Consolidation therapy: 50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29). Method of administration DepoCyte is to be administered by slow injection over a period of 1-5 minutes directly into the cerebrospinal fluid (CSF) via either an intraventricular reservoir or by direct injection into the lumbarMedicinal product no longer authorised 3 sac.
Following administration by lumbar puncture, it is recommended that the patient should be instructed to lie flat for one hour. All patients should be started on dexamethasone 4 mg twice daily either orally or intravenously for 5 days beginning on the day of injection of DepoCyte.
DepoCyte must not be administered by any other route of administration. 2). Patients should be observed by the physician for immediate toxic reactions. If neurotoxicity develops, the dose should be reduced to 25 mg. If it persists, treatment with DepoCyte should be discontinued.
Medicinal product no longer authorised 5 For Phase 1-4 studies in patients with lymphomatous meningitis receiving either DepoCyte or cytarabine adverse reactions are listed by MedDRA body system organ class and by frequency (Very common (≥1/10); and Common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)) in Table 1 below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. Adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1-4 study patients with lymphomatous meningitis receiving DepoCyte 50 mg (n = 151 cycles) or cytarabine (n = 99 cycles) Blood and lymphatic system disorders DepoCyte Cytarabine Very common: Thrombocytopenia Very common: Thrombocytopenia Nervous system disorders DepoCyte Cytarabine Very common: arachnoiditis, confusion, headache Very common: arachnoiditis, headache Common: confusion Gastrointestinal disorders DepoCyte Cytarabine Very common: diarrhoea, vomiting, nausea Very common: diarrhoea, vomiting, nausea General disorders and administration site conditions DepoCyte Cytarabine Very common: weakness, pyrexia Common: fatigue Very common: weakness, pyrexia, fatigue *Induction and Maintenance cycle lengths were 2 and 4 weeks, respectively, during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine.
Cytarabine patients not completing all 4 doses within a cycle are counted as a complete cycle. Nervous system disorders DepoCyte has the potential of producing serious neurological toxicity. Intrathecal administration of cytarabine may cause myelopathy (3%) and other neurologic toxicities sometimes leading to a permanent neurological deficit.
Following intrathecal administration of DepoCyte, serious central nervous system toxicity, including persistent convulsions (7%), extreme somnolence (3%), hemiplegia (1%), visual disturbances including blindness (1%), deafness (3%) and cranial nerve palsies (3%) have been reported.
g. 8), which is a very common adverse reaction. Arachnoiditis is a syndrome manifested primarily by nausea, vomiting, headache and fever. If left untreated, chemical arachnoiditis may be fatal. Patients should be informed about the expected adverse reactions of headache, nausea, vomiting and fever, and about the early signs and symptoms of neurotoxicity.
The importance of concurrent dexamethasone administration should be emphasised at the initiation of each cycle of DepoCyte treatment. Patients should be instructed to seek medical attention if signs or symptoms of neurotoxicity develop, or if oral dexamethasone is not well tolerated.
Cytarabine, when administered intrathecally, has been associated with nausea, vomiting and serious central nervous system toxicity which can lead to a permanent deficit, this includes blindness, myelopathy and other neurological toxicity.
Administration of DepoCyte in combination with other neurotoxic chemotherapeutic agents or with cranial/spinal irradiation may increase the risk of neurotoxicity. Infectious meningitis may be associated with intrathecal administration.
Hydrocephalus has also been reported, possibly precipitated by arachnoiditis. Blockage or reduction of CSF flow may result in increased free cytarabine concentrations in the CSF with increased risk of neurotoxicity. Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started.
Although significant systemic exposure to free cytarabine is not expected following intrathecal treatment, some effects on bone marrow function cannot be excluded. Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leucopenia, thrombocytopenia and anaemia.
Therefore monitoring of the haemopoietic system is advised. Anaphylactic reactions following intravenous administration of free cytarabine have been rarely reported. Medicinal product no longer authorised 4
1. Patients with active meningeal infection.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Symptoms and signs of peripheral neuropathy, such as pain (1%), numbness (3%), paresthesia (3%), hypoaesthesia (2%), weakness (13%), and impaired bowel (3%) and bladder control (incontinence) (1%), have also been observed and in some cases this combination of neurological signs and symptoms has been reported as Cauda equina syndrome (3%).
Adverse reactions possibly reflecting neurotoxicity are listed in Table 2 by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Medicinal product no longer authorised 6 Table 2:
Adverse reactions possibly reflecting neurotoxicities in Phase II, III, and IV patients receiving DepoCyte 50 mg (n = 99 cycles) or cytarabine ( n = 84 cycles) Psychiatric disorders DepoCyte Cytarabine Common: somnolence Common: somnolence Nervous system disorders DepoCyte Cytarabine Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness Eye disorders DepoCyte Cytarabine Common: visual disturbances, blindness Common: visual disturbances, blindness Ear and labyrinth disorders DepoCyte Cytarabine Common: deafness Common: deafness Gastrointestinal disorders DepoCyte Common: impaired bowel control Cytarabine Common: impaired bowel control Renal and urinary disorders DepoCyte Cytarabine Common: urinary incontinence Common: urinary incontinence General disorders and administration site conditions DepoCyte Cytarabine Very Common: weakness Common: pain Very Common: weakness Common: pain All patients receiving DepoCyte should be treated concurrently with dexamethasone to mitigate the symptoms of arachnoiditis.
Toxic effects may be related to a single dose or to cumulative doses. Because toxic effects can occur at any time during therapy (although they are most likely within 5 days of administration), patients receiving DepoCyte therapy should be monitored continuously for the development of neurotoxicity.
If patients develop neurotoxicity, subsequent doses of DepoCyte should be reduced, and treatment should be discontinued if toxicity persists. Arachnoiditis, a very common adverse reaction associated with DepoCyte, is a syndrome manifested by several adverse reactions.
The incidence of these adverse reactions, possibly reflecting meningeal irritation, are headache (24%), nausea (18%), vomiting (17%), pyrexia (12%), neck stiffness (3%), neck pain (4%), back pain (7%), meningism (<1%), convulsions (6%), hydrocephalus (2%), and CSF pleocytosis with or without altered state of consciousness (1%).
Table 3 below lists these reactions for patients treated DepoCyte, and for patients treated with methotrexate and cytarabine as well.
Adverse reactions are listed by MedDRA body system organ class and by frequency:
Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Medicinal product no longer authorised 7 Table 3:
Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients Nervous system disorders DepoCyte (n = 929 cycles) Methotrexate (n = 258 cycles) Cytarabine (n = 99 cycles) Very common: headache Common: convulsions, hydrocephalus acquired, CSF pleocytosis Uncommon: meningism Very common: headache Common: convulsions, hydrocephalus acquired, meningism Very common: headache Common: convulsions, […]