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CYTOSAR is a brand name for Cytarabine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Clinical experience accumulated to date suggests that success with Cytosar is dependent more on adeptness in modifying day-to-day dosage to obtain maximum leukemic cell kill with tolerable toxicity than on the basic treatment schedule chosen at the outset of therapy.
Toxicity necessitating dosage alteration almost always occurs. In many chemotherapeutic programs, Cytosar is used in combination with other cytotoxic drugs. The addition of these cytotoxic drugs has necessitated changes and dose alterations.
The dosage schedules for combination therapy outlined below have been reported in the literature (see REFERENCES). Recommended Dose and Dosage Adjustment Acute myelocytic leukemia - induction remission: adults Cytosar 200 mg/m2 daily by continuous infusion for 5 days (120 hours) - total dose 1000 mg/m2.
This course is repeated approximately every 2 weeks. Modifications must be made based on hematologic response. Acute myelocytic leukemia - maintenance: adults Maintenance programs are modifications of induction programs and, in general, use similar schedules of drug therapy as were used during induction.
Most programs have a greater time spacing between courses of therapy during remission maintenance. Acute myelocytic leukemia - induction and maintenance in children Numerous studies have shown that childhood AML responds better than adult AML given similar regimens.
Where the adult dosage is stated in terms of body weight or surface area, the children's dosage may be calculated on the same basis. When specified amounts of a drug are indicated for the adult dosage, these should be adjusted for children on the basis of such factors as age, body weight or body surface area.
Acute myelocytic leukemia – adults and children The following tables outline the results of treatment with Cytosar alone and in combination with other chemotherapeutic agents, in the treatment of acute myelocytic leukemia in adults and children.
The treatment regimens outlined in the tables should not be compared for efficacy. These were independent studies with a number of variables involved, such as patient population, duration of disease, and previous treatment. The responsiveness and course of childhood acute myelocytic leukemia (AML) appear to be different from that in adults.
Cytosar (cytarabine) is contraindicated in those patients who are hypersensitive to the drug. Anaphylactic reactions have occurred with Cytosar treatment (see WARNINGS AND PRECAUTIONS, Sensitivity/Resistance). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Cytosar (cytarabine) should be prescribed only by physicians experienced with cancer therapy drugs.
Patients should be monitored and blood counts as well as renal and hepatic function tests should be performed regularly (see WARNINGS AND PRECAUTIONS, Hematologic, Hepatic/Biliary/Pancreatic, Renal, Monitoring and Laboratory Tests and OVERDOSAGE).
Do not use a diluent that contains benzyl alcohol when giving to premature or low birth weight infants as benzyl alcohol has been associated with the “gasping syndrome” (see WARNINGS AND PRECAUTIONS, General and Special Populations, Pediatrics).
Do not use a diluent that contains benzyl alcohol for high dose therapy or when using intrathecally (see ADVERSE REACTIONS, High Dose Therapy and DOSAGE AND ADMINISTRATION, Reconstitution, Lyophilized Powder). The following are clinically significant adverse events: Cardiomyopathy with subsequent death (see WARNINGS AND PRECAUTIONS, Cardiovascular and ADVERSE REACTIONS, High Dose Therapy).
GI toxicity, at times fatal (see WARNINGS AND PRECAUTIONS, Gastrointestinal and ADVERSE REACTIONS, High Dose Therapy). Acute pancreatitis (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). CNS toxicity, severe neurological adverse reactions, paraplegia, necrotizing leukoencephalopathy and spinal cord toxicity.
Patients with impaired hepatic or renal function may be at increased risk after high dose Cytosar (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Neurologic and Renal; ADVERSE REACTIONS, High Dose Therapy and Intrathecal Therapy; DRUG INTERACTIONS, Serious Interactions; DOSAGE AND ADMINISTRATION, Meningeal Leukemia – Intrathecal Use, OVERDOSAGE, and ACTION AND CLINICAL PHARMACOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cytarabine in Canada.
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Numerous studies show response rates to be higher in children than in adults with similar treatment schedules. Experience indicates that at least with induction and initial drug responsiveness, childhood AML appears to be more similar to childhood acute lymphocytic leukemia (ALL) than to its adult variant.
CYTOSAR (cytarabine) Product Monograph Page 17 of 51 Patients with hepatic impairment: Cytarabine and dose adjustment has not been studied in individuals with hepatic impairment (see also WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Patients with renal impairment:
Cytarabine and dose adjustment has not been studied in individuals with renal impairment (see also WARNINGS AND PRECAUTIONS, Renal). CYTOSAR (cytarabine) Product Monograph Page 18 of 51 TABLE I Acute Myelocytic Leukemia - Remission Induction: Adults Drug Dosage Schedule* No.
v. v. synchronizing dose** 5 5 (100%) Lampkin (1976) Combined Therapy Cytosar – doxorubicin 41 30 (73%) Preisler (1979) Cytosar - thioguanine daunorubicin 28 22 (79%) Gale (1977) Cytosar - doxorubicin vincristine – prednisolone 35 23 (66%) Weinstein (1980) Cytosar - daunorubicin thioguanine – prednisone vincristine 139 84 (60%) Glucksberg (1981) Cytosar – daunorubicin 21 14 (67%) Cassileth (1977) CYTOSAR (cytarabine) Product Monograph Page 19 of 51 TABLE I (Cont'd) Acute Myelocytic Leukemia - Remission Induction: Adults Drug Dosage Schedule* No.
of Patients Evaluated Complete Remissions Investigator High Dose Therapy Cytosar 7 6 (86%) Lister (1983) Cytosar 21 12 (57%) Herzig (1983) Cytosar Cytosar 11 8 (73%) Preisler (1983) Cytosar - doxorubicin 14 7 (50%) Willemze (1982) Cytosar - asparaginase 13 9 (69%) Capizzi (1983) * Unless otherwise stated, all doses given until drug effect-modifications then based on hematologic reasons.
See REFERENCES. ** Highly experimental - requires ability to study mitotic indices.
TABLE II Acute Myelocytic Leukemia - Remission Induction:
Children (21 and under) Drug Therapy No. v. synchronizing dose**) 16 12 (75%) Lampkin (1976) Cytosar, vincristine, doxorubicin, prednisolone 48 35 (73%) Weinstein (1980) Cytosar, thioguanine, doxorubicin 11 8 (72%) Hagbin (1975) Cytosar, thioguanine 47 20 (43%) Pizzo (1976) Cytosar, cyclophosphamide 12 7 (58%) Pizzo (1976) ** Highly experimental - requires ability to study mitotic indices.
CYTOSAR (cytarabine) Product Monograph Page 20 of 51 Acute lymphocytic leukemia In general, dosage schedules are similar to those used in acute myelocytic leukemia with some modification. Cytosar has been used in the treatment of acute lymphocytic leukemia in both adults and children.
When Cytosar was used with other antineoplastic agents as part of a total therapy program, results were equal to or better than reported with such programs which did not include Cytosar. Used singly, or in combination with other agents, Cytosar has also been effective in treating patients who had relapsed on other therapy.
Table III and IV summarize the […]
Infection (see WARNINGS AND PRECAUTIONS, Immune and ADVERSE REACTIONS, Infections and Infestations). Pulmonary toxicity, adult respiratory distress syndrome and pulmonary edema (see WARNINGS AND PRECAUTIONS, Respiratory and ADVERSE REACTIONS, High Dose Therapy).
Myelosuppression (see WARNINGS AND PRECAUTIONS, Hematologic; ADVERSE REACTIONS, Blood and Lymphatic System Disorders and OVERDOSAGE). CYTOSAR (cytarabine) Product Monograph Page 5 of 51 General Before instituting a programme of combined therapy, the physician should be familiar with the literature, adverse reactions, warnings and precautions, and contraindications applicable to all the drugs in the programme (see DOSAGE AND ADMINISTRATION, Combined Chemotherapy).
For induction therapy, patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of Cytosar is bone marrow suppression with leukopenia, thrombocytopenia and anemia.
Less serious toxicity includes nausea, vomiting, diarrhoea and abdominal pain, oral ulceration, and hepatic dysfunction (see ADVERSE REACTIONS). The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with Cytosar.
Before making this judgment or beginning treatment, the physician should be familiar with the following text. When large intravenous doses are given quickly, patients are frequently nauseated and may vomit for several hours post injection.
This problem tends to be less severe when the drug is infused. Bacteriostatic water, one of the diluents recommended for reconstitution of Cytosar, contains benzyl alcohol (see DOSAGE AND ADMINISTRATION, Reconstitution, Lyophilized Powder).
Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in pediatric patients. As premature and low birth weight infants may be at increased risk of developing this toxicity, they should not be given cytarabine reconstituted with a diluent containing benzyl alcohol (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Carcinogenesis and Mutagenesis Extensive chromosomal damage, including chromatoid breaks have been produced by cytarabine and malignant transformation of rodent cells in culture has been reported (see DETAILED PHARMACOLOGY).
Cardiovascular High dose schedules:
An increase in cardiomyopathy with subsequent death has been reported following experimental high dose Cytosar and cyclophosphamide therapy when used for bone marrow transplant preparation. This may be schedule dependent (see also DRUG INTERACTIONS).
Gastrointestinal Abdominal tenderness (peritonitis) and typhlitis with concurrent neutropenia and thrombocytopenia have been reported in patients treated with conventional doses of cytarabine in combination with other drugs. Patients have responded to nonoperative medical management.
High dose schedule:
Severe and at times fatal, GI toxicity (different from that seen with conventional therapy regimens of Cytosar) has been reported following high dose (2-3 g/m2) schedules of Cytosar. These reactions include severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis, leading to peritonitis, bowel necrosis; and necrotizing colitis.
CYTOSAR (cytarabine) Product Monograph Page 6 of 51 Genitourinary Tumor Lysis Syndrome: Like other cytotoxic drugs, Cytosar may induce hyperuricemia secondary to rapid lysis of neoplastic cells. The clinician should monitor the patient's blood uric acid level and be prepared to use such supportive and pharmacologic measurements as might be necessary to control this problem.
Hematologic Cytosar (cytarabine) is a potent bone marrow suppressant; the severity depends on the dose of the drug and schedule of administration. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression.
Patients receiving this drug […]