Medicinal Products

DEPOCYTE 50 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Cytarabine
laboratory: Pacira Limited

Injectable suspension
Box of 1 bottle of 5 ml
All forms

Indication

Intrathecal treatment of lymphomatous meningitis. In most patients, such treatment will be part of the palliative care of the disease.

Dosage DEPOCYTE 50 mg Suspension for injection Box of 1 vial of 5 ml

DepoCyte should only be administered under the supervision of a physician experienced in the use of anticancer agents.
- Adults and seniors :
For the treatment of lymphomatous meningitis, the dose for adults is 50 mg (one vial) administered intrathecally (lumbar puncture or intraventricular injection via an Ommaya reservoir). The following induction, consolidation and maintenance regimen is recommended.
. Induction treatment: 50 mg, administered at 14-day intervals for 2 doses (weeks 1 and 3).
. Consolidation treatment: 50 mg given at 14-day intervals for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
. Maintenance treatment: 50 mg administered at 28-day intervals for 4 doses (weeks 17, 21, 25 and 29).
. Method of administration: DepoCyte should be administered by slow injection over a period of 1 to 5 minutes directly into the cerebrospinal fluid (CSF) either via an intraventricular reservoir or by direct injection into the lumbar sac. After administration by lumbar puncture, it is recommended to ask the patient to lie flat for one hour. Patients should start treatment with oral or IV dexamethasone 4 mg twice daily for 5 days from the day of DepoCyte injection.
. DepoCyte should not be given by another route.
. DepoCyte should be used as is; do not dilute it (see incompatibilities section).
. Patients must be under medical supervision to detect an immediate toxic reaction. If neurotoxicity develops, the dosage should be reduced to 25 mg. If it persists, treatment with DepoCyte should be discontinued.
- Children and adolescents :
The safety and efficacy of this drug have not been formally demonstrated in children (see section 5.1 Pharmacodynamic properties). DepoCyte is not recommended for use in children and adolescents until additional data are available.

Against indications

CONTRAINDICATED:
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with active meningeal infection.
- Pregnancy: No animal teratogenesis studies have been conducted with DepoCyte and there are no adequate and well-controlled clinical studies in pregnant women, however cytarabine, when administered during pregnancy, may be toxic to the fetus. Therefore, women who may be pregnant should not receive this treatment until pregnancy is excluded and should be advised to use effective contraception. Since cytarabine has a mutagenic potential that could induce chromosomal damage in human sperm, men treated with DepoCyte and their partners should be advised to use a safe method of contraception.
NOT RECOMMENDED :
- Children and adolescents: The safety and efficacy of this medication have not been formally demonstrated in children. DepoCyte is not recommended for use in children and adolescents until additional data are available.
- Breast-feeding: It is not known if cytarabine is excreted in breast milk after intrathecal administration. Systemic exposure to free cytarabine after intrathecal administration of DepoCyte is negligible. Due to the possible excretion in breast milk and the risk of serious side effects in breast-fed babies, the use of DepoCyte is not recommended for women who are breastfeeding.

Adverse effects Depocyte

- DepoCyte has a significant toxic potential.
- All patients receiving DepoCyte should be treated concomitantly with corticosteroids (eg dexamethasone) to alleviate the symptoms of arachnoiditis. Toxic effects may be related to single dose or cumulative doses. Since toxic effects can occur at any time during treatment (although it is more likely that they will occur within five days of administration), patients treated with DepoCyte should be monitored regularly in the event of Neurotoxicity.If patients develop neurotoxicity, the following doses of DepoCyte should be reduced and DepoCyte should be discontinued if toxicity persists.
- arachnoiditis, a syndrome manifested mainly by headaches, nausea, vomiting, fever, stiffness of the neck, neck or back pain, meningism, seizures, hydrocephalus, CSF pleocytosis, with or without impaired consciousness, is a common adverse effect. If left untreated, arachnoiditis can be fatal.
- The incidence of adverse events, possibly reflecting a meningeal syndrome, determined from all patients treated with 50 mg DepoCyte during Phase II-IV clinical trials, is shown in Table 1 below:
Table 1. Adverse reactions possibly reflecting meningeal syndrome in patients in Phases II, III and IV [n (%) cycles * of treatment] :
DepoCyte (n = 929 cycles) / Methotrexate (n = 258 cycles) / Cytarabine (n = 99 cycles).
. HeadacheSAP: 24% / 16% / 14%.
. Nausea: 18% / 12% / 15%.
. Vomiting SAP: 17% / 11% / 11%.
. Arachnoiditis: 16% / 7% / 13%.
. Pyrexia: 12% / 7% / 16%.
. Lumbar pain: 7% / 7% / 6%.
. ConvulsionsSAP: 6% / 5% / 2%.
. Cervical pain: 4% / 3% / 3%.
. Cervical stiffness: 3% / <1% / 4%.
. Hydrocephalic acid: 2% / 1% / 0%. . CSF pleocytosis: 1% / 0% / 0%.
. Meningism: <1% / 1% / 1%.
* The duration of the cycle was 2 weeks, during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine or methotrexate. Patients on cytarabine and methotrexate who have not taken all 4 doses are counted as part of a cycle.
- The incidence of all adverse events occurring in> 10% of cycles in either treatment group of patients with stage I-IV lymphomatous meningitis who are receiving DepoCyte or cytarabine, is shown in Table 2 below:
Table 2. Adverse reactions occurring in> 10% of cycles in either treatment group with stage I-IV lymphomatous meningitis receiving 50 mg DepoCyte or cytarabine (% of treatment cycles *) :
DepoCyte (n = 151 cycles) / Cytarabine (n = 99 cycles).
. Nervous system disorders:
SAP Headache: 23% / 14%.
Arachnoiditis: 16% / 13%.
Confusion: 11% / 3%.
. Gastrointestinal disorders:
Nausea: 13% / 15%.
Vomiting SAP: 12% / 11%.
SAP diarrhea: 11% / 10%.
. General disorders and conditions of the administration site:
Weakness: 13% / 17%.
Pyrexia: 14% / 16%.
Fatigue: 6% / 14%.
. Blood and lymphatic system disorders:
Thrombocytopenia: 10% / 13%. * The duration of the induction and maintenance cycles were respectively 2 and 4 weeks, during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine. Patients on cytarabine who have not taken all 4 doses in one cycle are counted as one complete cycle.
Intrathecal administration of cytarabine may cause myelopathy and other neurological toxicities sometimes leading to permanent neurological deficit. Following intrathecal administration of DepoCyte, severe central nervous system toxicity including extreme persistent drowsiness, confusion, hemiplegia, impaired vision including blindness, deafness and cranial nerve palsy have been reported. . Symptoms and signs of peripheral neuropathy, such as pain, numbness, paresthesia, hypesthesia, weakness, and bladder and bowel involvement (incontinence) have also been observed.
- The most common side effects associated with DepoCyte are headache, arachnoiditis and confusion. In addition, in Phase I-IV studies, the incidence of convulsions in the patient was higher in the DepoCyte group (7/33, 21%) than in the cytarabine group (1/28, 4%).
Transient elevations of protein and leukocytes in CSF have also been observed following DepoCyte administration and have also been noted following intrathecal treatment with methotrexate or cytarabine.

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