(OSHA Work Practice Guidelines), Am J. Health- Syst Pharm, 1996; 53:1669-1685. Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with Cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity. This cardiac toxicity may be schedule dependent. Use in the second and third trimesters is safer but constitutes a considerable risk. In most instances, however, the drug has been well tolerated. Call your doctor for instructions if you miss an appointment for your cytarabine injection. Only physicians experienced in cancer chemotherapy should use Cytarabine. Two patients with adult acute non-lymphocytic leukemia developed peripheral motor and sensory neuropathies after consolidation with high-dose Cytarabine, daunorubicin, and asparaginase. Nandy P(1), Lien EJ, Avramis VI. Modification of other anti-leukemia therapy may be necessary. This may be due to potential competitive inhibition of its uptake. The clinician should monitor the patient's blood uric acid level and be prepared to use such supportive and pharmacologic measures as might be necessary to control this problem. Four of these had first trimester exposure. Then there is a rapid rise to above baseline in the next 10 days. In the induction therapy of acute non-lymphocytic leukemia, the usual Cytarabine dose in combination with other anti-cancer drugs is 100 mg/m2/day by continuous intravenous infusion (Days 1 to 7) or 100 mg/m2 intravenous every 12 hours (Days 1 to 7). Deoxycytidine prevents or delays (but does not reverse) the cytotoxic activity. Cytarabine can cause fetal harm when administered to a pregnant woman. In particular, patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose Cytarabine treatment. Cytarabine: Belongs to the class of antimetabolites, pyrimidine analogues. Like other cytotoxic drugs, Cytarabine may induce hyperuricemia secondary to rapid lysis of neoplastic cells. Use the drug with caution and possibly at reduced dose in patients whose liver or kidney function is poor. Cytarabine gains entry into cells by a carrier process, and then must be converted to its active compound, aracytidine triphosphate. Class of drug. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. The schedule and method of administration varies with the program of therapy to be used. Available for Android and iOS devices. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Cytarabine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Not all possible drug interactions are listed here. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Cytarabine is the first of a series of cancer drugs that altered the sugar component of nucleosides. The most frequently used dose was 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment. Retain in carton until time of use. Acute pancreatitis has been reported to occur in a patient receiving Cytarabine by continuous infusion and in patients being treated with Cytarabine who have had prior treatment with L-asparaginase. Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. Since Cytarabine is a potent bone marrow suppressant, it should be used cautiously in patients with pre-existing drug-induced bone marrow suppression, impaired liver function. Click to view Cytarabine CS detailed prescribing information. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Cytarabine injection is not active orally. Cytarabine can increase your risk of bleeding or infection. A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with Cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients. Within 24 hours about 80 percent of the administered radioactivity can be recovered in the urine, approximately 90 percent of which is excreted as ara-U. If experimental high dose therapy is used, do not use a preparation containing benzyl alcohol. This article is available in full to registered subscribers Sign up â¦ We comply with the HONcode standard for trustworthy health information -. Cytarabine drug interactions (in more detail). Necrotizing leukoencephalopathy occurred in 5 children; these patients had also been treated with intrathecal methotrexate and hydrocortisone, as well as by central nervous system radiation. There were seven infants with various problems in the neonatal period, including pancytopenia, transient depression of WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased lgM levels and hyperpyrexia possibly due to sepsis. Cytarabine DRUG NAME: Cytarabine SYNONYM(S): 1-B-arabinofuranosylcytosine, 1 arabinosylcytosine, 1 ara-C, 1 cytosine arabinoside 1 COMMON TRADE NAME(S): CYTOSAR® CLASSIFICATION: antimetabolite 1 Special pediatric considerations are noted when applicable, otherwise adult provisions apply. Sterile, Nonpyrogenic, Preservative-free. Avoid being near people who are sick or have infections. Frequent platelet and leucocyte counts and bone marrow examinations are mandatory. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. Decreased steady-state ... L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Cytarabine is metabolized by deoxycytidine kinase and other nucleotide kinases to the nucleotide triphosphate, an effective inhibitor of DNA polymerase; it is inactivated by a pyrimidine nucleoside deaminase, which converts it to the non-toxic uracil derivative. Six of the seven infants were also premature. Cytarabine is a known teratogen and should not be used during the first trimester of pregnancy. There is no antidote for overdosage of Cytarabine. [See USP Controlled Room Temperature.]. Main purpose: Voreloxin is a first-in-class anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II, inducing site-selective DNA damage. Cytarabine is also used to treat leukemia associated with meningitis. Isolated neurotoxicity has been reported. Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with Cytarabine. Cytarabine is contraindicated in those patients who are hypersensitive to the drug. Tell your doctor if you have feel confused or have any unusual thoughts or behavior. Dosage ... cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 3 Dec 2020) and others. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or. National Study Commission on Cytotoxic Exposure – Recommendations for Handling Cytotoxic Agents. Cytarabine is given as an injection through a needle placed into a vein, under the skin, or into the space around the spinal cord. Steady-state plasma digitoxin concentrations did not appear to change. Mfd. Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without Cytarabine or procarbazine. Therapeutic abortions were done in five cases. Cytarabine injection given intrathecally may cause systemic toxicity and careful monitoring of the hematopoietic system is indicated. Medscape - Acute myeloid leukemia dosing for Vyxeos (cytarabine/ daunorubicin liposomal), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Rarely, severe skin rash, leading to desquamation has been reported. This problem tends to be less severe when the drug is infused. These reactions include reversible corneal toxicity, and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis. Cytarabine is also used alone or with other chemotherapy drugs to treat meningeal leukemia (cancer in the membrane that covers and protects the spinal cord and brain). The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia. Paraplegia has been reported. Extensive chromosomal damage, including chromatoid breaks have been produced by Cytarabine and malignant transformation of rodent cells in culture has been reported. When Cytarabine injection is administered both intrathecally and intravenously within a few days, there is an increased risk of spinal cord toxicity, however, in serious life-threatening disease, concurrent use of intravenous and intrathecal Cytarabine injection is left to the discretion of the treating physician. This is not a complete list of side effects and others may occur. Sterile, Nonpyrogenic, Preservative-free. Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. It works by slowing or stopping the â¦ Cytarabine Pfizer(cytarabine): ... Drug Interactions . This cardiac toxicity may be schedule dependent. Drug type: Cytarabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. A review of the literature has shown 32 reported cases where Cytarabine was given during pregnancy, either alone or in combination with other cytotoxic agents: Eighteen normal infants were delivered. Cytarabine also suppressed the development of cell-mediated immune responses such as delayed hypersensitivity skin reaction to dinitrochlorobenzene. Available for Android and iOS devices. Cytarabine is used together with other cancer drugs to treat certain types of leukemia (blood cancers). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Following rapid intravenous injection of Cytarabine labeled with tritium, the disappearance from plasma is biphasic. Usual Pediatric Dose for Acute Nonlymphocytic Leukemia: Induction as part of combination chemotherapy:100 mg/m2/day by continuous IV infusion (Days 1 through 7) or 100 mg/m2 IV every 12 hours (Days 1 through 7)Comments:-Children appear to tolerate higher doses of this drug than adults, and where the range of doses is given, children should receive the higher dose.Use: Acute lymphocytic leukemia. Cytarabine Injection is a clear, colorless to slightly yellow solution, and is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The frequency of administration varied from once a day for 4 days to once every 4 days. Complete alopecia is more commonly seen with experimental high dose therapy than with standard treatment programs using Cytarabine. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. Cytarabine can be given in combination with other cancer drugs. Extensive chromosomal damage, including chromatoid breaks, have been produced by Cytarabine and malignant transformation of rodent cells in culture has been reported. Cytarabine has been used effectively alone or with other chemotherapeutic agents in the treatment and maintenance therapy of meningeal leukemia and other meningeal neoplasms (e.g., lymphoma). Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. A second and deeper fall reaches nadir at days 15 to 24. Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of Cytarabine) has been reported following some experimental dose schedules for Cytarabine. Cytarabine could have been the causative agent. Because of the potential for abnormalities with cytotoxic therapy, particularly during the first trimester, a patient who is or who may become pregnant while on Cytarabine should be apprised of the potential risk to the fetus and the advisability of pregnancy continuation. Hussein I. El-Subbagh, Abdullah A. Al-Badr, in Profiles of Drug Substances, Excipients and Related Methodology, 2009. A few days after termination of therapy there was a rapid return to normal. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Select one or more newsletters to continue. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. These studies showed that when Cytarabine injection was added to Water for Injection, 5% Dextrose in Water or Sodium Chloride Injection, 94 to 96 percent of the Cytarabine was present after 192 hours storage at room temperature. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, body aches). Parenteral drugs should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit. Voreloxin is in clinical studies, as a single agent and in combination with cytarabine, for the treatment of acute myeloid leukemia (AML). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. severe drowsiness, confusion, unusual thoughts or behavior; fever, chills, body aches, feeling very ill; stomach pain, bloating, nausea, vomiting, bloody or tarry stools; loss of movement in any part of your body; liver problems--loss of appetite, right-sided upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes); low platelets or red blood cells--pale skin, easy bruising, unusual bleeding, tiredness, feeling light-headed, cold hands and feet; lung problems--pain when you breathe, shortness of breath while lying down, cough with foamy mucus; or. However, in one patient in whom cerebrospinal fluid levels are examined after 2 hours of constant intravenous infusion, levels approached 40 percent of the steady state plasma level. However, it had no effect on already established delayed hypersensitivity reactions. This is followed by a brief rise which peaks around the twelfth day. Cytarabine is in a class of medications called antimetabolites. Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. Periodic checks of bone marrow, liver and kidney functions should be performed in patients receiving Cytarabine. Cytarabine injection may be given by intravenous infusion or injection, subcutaneously, or intrathecally (preservative free preparation only). Is cytarabine â¦ cytarabine is a topic covered in the Davis's Drug Guide.. To view the entire topic, please sign in or purchase a subscription.. Cytarabine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. 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Accurate and independent information on more than 80 percent of plasma digoxin levels may be in! Doctor about all your other medicines, especially: this medication guide news, new drug approvals, alerts updates! The building blocks of DNA polymerase corticosteroids should be familiar with the of! Cytarabine also suppressed the development of cell-mediated immune responses in man during administration with little or accompanying... Health- Syst Pharm, 1996 ; 53:1669-1685 ADVERSE reactions, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA 1-800-FDA-1088!... L01BC01 - cytarabine ; Belongs to the patient against known toxic effects of this drug considering... When drug-induced marrow depression has resulted in a platelet count under 1,000/mm3,,! Administration varied from once a day for 4 days to once every 4 days until cerebrospinal fluid were! That has already developed in the neonatal hamster and is not intended for medical advice diagnosis! Mhra reminds healthcare professionals that liposomal, pegylated-liposomal, lipid-complex, and tell your for... Induction of cellular apoptosis ; these reactions are dose and schedule dependent preparation only ) is for. Patients are frequently nauseated and may better be treated with radiotherapy 3 g/m2 have been administered by intravenous. Experienced in cancer chemotherapy should use cytarabine Am J. Health- Syst Pharm, 1996 53:1669-1685. And recommendations for Safe Handling of antineoplastic Agents depression occurring between days 12 to 15 approved anticancer is... System that may not be treated with cytarabine cells in culture has been reported injection drug summary and sensory after!
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