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CYTARABINE 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.
Cytarabine Injection (cytarabine) is contraindicated in those patients who are hypersensitive to the drug. Anaphylactic reactions have occurred with cytarabine treatment (see WARNINGS AND PRECAUTIONS, Sensitivity/Resistance). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Cytarabine Injection (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). 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 Cytarabine Injection (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).
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). Product Monograph - PrCytarabine Injection Page 5 of 42 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).
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia.
Less serious toxicity includes nausea, vomiting, diarrhea 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 cytarabine.
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. 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 cytarabine 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 cytarabine) has been reported following high dose (2 - 3 g/m2) schedules of cytarabine. These reactions include severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis, leading to peritonitis, bowel necrosis; and necrotizing colitis.
Product Monograph - PrCytarabine Injection Page 6 of 42 Genitourinary Tumor Lysis Syndrome: Like other cytotoxic drugs, Cytarabine Injection 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 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 must be under close medical supervision and during induction therapy, should have leukocyte and platelet counts performed daily. […]