Tell your doctor at once if you develop signs of infection. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. Paraplegia has been reported. Cytarabine is rapidly metabolized and is not effective orally; less than 20 percent of the orally administered dose is absorbed from the gastrointestinal tract. Cytarabine: Belongs to the class of antimetabolites, pyrimidine analogues. 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). Like other cytotoxic drugs, Cytarabine may induce hyperuricemia secondary to rapid lysis of neoplastic cells. Cytarabine injection has been used intrathecally in acute leukemia in doses ranging from 5 mg/m2 to 75 mg/m2 of body surface area. A second and deeper fall reaches nadir at days 15 to 24. Therapeutic abortions were done in five cases. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Usual Pediatric Dose for Acute Lymphocytic Leukemia: Usual Pediatric Dose for Meningeal Leukemia: The dose ranges from 5 mg/m2 to 75 mg/m2 intrathecally once a day for 4 days to once every 4 days (30 mg/m2 every 4 days until cerebrospinal fluid findings are normal, followed by one additional treatment is the most frequently used dose)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.-Only the preservative free formulation of this drug should be administered intrathecally.Use: Meningeal leukemia. Cytarabine inhibits DNA synthesis. ©2020 Meitheal Pharmaceuticals Inc. For Intravenous, Intrathecal and Subcutaneous Use Only, prednisone, triamcinolone, methotrexate, dexamethasone, Decadron, hydroxyurea, rituximab, Imbruvica, cyclophosphamide, Rituxan. Available for Android and iOS devices. Nausea and vomiting are most frequent following rapid intravenous injection. Author information: (1)Department of Pediatrics, USC School of Medicine, Childrens Hospital Los ⦠(OSHA Work Practice Guidelines), Am J. Health- Syst Pharm, 1996; 53:1669-1685. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. Combination drug program (LSA2L2) including cytarabine: Childn w/ non-Hodgkin's lymphoma. Sterile, Nonpyrogenic, Preservative-free. 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. Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Deoxycytidine prevents or delays (but does not reverse) the cytotoxic activity. Cytarabine drug manufacturers and companies such as Mayne Pharma. When large intravenous doses are given too quickly, patients are frequently nauseated and may vomit for several hours post-injection. 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. Other cancer drugs modify the base. The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. 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. Generic Name: cytarabine (sye TAR a been)Brand Name: Cytosar-U, Tarabine PFS, CytosarDosage Forms: injectable solution (100 mg/mL; 20 mg/mL), Medically reviewed by Drugs.com on Dec 4, 2020 â Written by Cerner Multum. It exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells from the G1 phase to the S-phase. Cytarabine is employed either as a single agent or in combination with others, specially the anthracyclines, and is the prime example of an antitumor drug specifically acting in the S-phase of the cell cycle because its incorporation into DNA after being activated to the corresponding triphosphate leads to inhibition of strand elongation (Fig. National Study Commission on Cytotoxic Exposure – Recommendations for Handling Cytotoxic Agents. Cerebrospinal fluid levels of Cytarabine are low in comparison to plasma levels after single intravenous injection. Corticosteroids have been shown to be beneficial in treating or preventing this syndrome. This medication is classified as an "antimetabolite." meitheal® Both of these cases had first trimester exposure. Cytarabine injection given intrathecally may cause systemic toxicity and careful monitoring of the hematopoietic system is indicated. 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. You may report side effects to FDA at 1-800-FDA-1088. The container closure is not made with natural rubber latex. The utilization of digitoxin for such patients may be considered as an alternative. Cytarabine is sp⦠The dosage schedule is usually governed by the type and severity of central nervous system manifestations and the response to previous therapy. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Rarely, severe skin rash, leading to desquamation has been reported. Two cases of congenital abnormalities have been reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Regulatory Classification. Drug type: Cytarabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Cytarabine can cause fetal harm when administered to a pregnant woman. Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. (For more detail, see "How cytarabine works" section below). Medically reviewed by Drugs.com. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Cytarabine gains entry into cells by a carrier process, and then must be converted to its active compound, aracytidine triphosphate. We comply with the HONcode standard for trustworthy health information -. Cytarabine injection is not active orally. The severity of these reactions are dose and schedule dependent. Although the mechanism of action is not completely understood, it appears that Cytarabine acts through the inhibition of DNA polymerase. It works by slowing or ⦠It is not known whether this drug is excreted in human milk. It appears that the balance of kinase and deaminase levels may be an important factor in determining sensitivity or resistance of the cell to Cytarabine. This is not a complete list of side effects and others may occur. 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. Cytarabine is used to treat certain types of leukemia (blood cancers). Focal leukemic involvement of the central nervous system may not respond to intrathecal Cytarabine injection and may better be treated with radiotherapy. Consider suspending or modifying therapy when drug-induced marrow depression has resulted in a platelet count under 50,000 or a polymorphonuclear granulocyte count under 1,000/mm3. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Frequent platelet and leucocyte counts and bone marrow examinations are mandatory. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. Cytarabine can increase your risk of bleeding or infection. 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. It usually occurs 6 to 12 hours following drug administration. Cytarabine is in a class of medications called antimetabolites. The structural formula is: Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. Cytarabine, ARA-C is a FDA pregnancy risk category D drug. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). 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 of Cytarabine. Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. 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). Although the mechanism of action is not completely understood, it appears that Cytarabine acts through the inhibition of DNA polymerase. Follow your doctor's dosing instructions very carefully. This cardiac toxicity may be schedule dependent. If the symptoms of the syndrome are deemed treatable, corticosteroids should be contemplated as well as continuation of therapy with Cytarabine. Copyright 1996-2018 Cerner Multum, Inc. Ten patients treated with experimental intermediate doses of Cytarabine (1 g/m2) with and without other chemotherapeutic agents (meta-AMSA, daunorubicin, etoposide) at various dose regimes developed a diffuse interstitial pneumonitis without clear cause that may have been related to the Cytarabine. It exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells from the G1 phase to the S-phase. Extensive chromosomal damage, including chromatoid breaks have been produced by Cytarabine and malignant transformation of rodent cells in culture has been reported. You should not breastfeed while you are receiving cytarabine. Regulatory Classification. Major toxicity is rare. A Cytarabine syndrome has been described by Castleberry. Other drugs may affect cytarabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Cytarabine is a known teratogen and should not be used during the first trimester of pregnancy. This may be due to potential competitive inhibition of its uptake. The outcome of this syndrome can be fatal. Cytarabine is usually given for only a few days at a time. This phenomenon is related to the drug's rapid inactivation and brief exposure of susceptible normal and neoplastic cells to significant levels after rapid injection. Twelve of the 18 normal infants were followed up at ages ranging from six weeks to seven years, and showed no abnormalities. Version: 9.01. prednisone, triamcinolone, methotrexate, dexamethasone, Decadron, hydroxyurea, rituximab, Imbruvica, cyclophosphamide, Rituxan. Mfd. After receiving an injection, you will be watched closely to make sure you do not have serious side effects. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. During treatment you usually see a cancer doctor, a chemotherapy nurse or a specialist nurse, and a specialist pharmacist. Protect from light. Am J. Hosp. Following rapid intravenous injection of Cytarabine labeled with tritium, the disappearance from plasma is biphasic. Cytarabine will not treat an active meningitis infection that has already developed in the body. This occurred immediately after the intravenous administration of Cytarabine. Cytarabine also suppressed the development of cell-mediated immune responses such as delayed hypersensitivity skin reaction to dinitrochlorobenzene. Select one or more newsletters to continue. Steady-state plasma digitoxin concentrations did not appear to change. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Then there is a rapid rise to above baseline in the next 10 days. The frequency of administration varied from once a day for 4 days to once every 4 days. Retain in carton until time of use. A few days after termination of therapy there was a rapid return to normal. After subcutaneous or intramuscular administration of Cytarabine labeled with tritium, peak-plasma levels of radioactivity are achieved about 20 to 60 minutes after injection and are considerably lower than those after intravenous administration. Each mL contains 20 mg Cytarabine, USP (20 mg per mL) in a single dose vial (100 mg per 5 mL). The child with pancytopenia died at 21 days of sepsis. One apparently normal infant died at 90 days of gastroenteritis. 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. Inhibition of ribonucleotide reductase by a new class of isoindole derivatives: drug synergism with cytarabine (Ara-C) and induction of cellular apoptosis. There is no antidote for overdosage of Cytarabine. 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). Antimetabolite antineoplastic agent Chemotherapy: general principles. 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. 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). Used in the treatment of cancer. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, body aches). If experimental high dose therapy is used, do not use a preparation containing benzyl alcohol. 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. 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. Voreloxin is in clinical studies, as a single agent and in combination with cytarabine, for the treatment of acute myeloid leukemia (AML). The MHRA reminds healthcare professionals that liposomal, pegylated-liposomal, lipid-complex, and conventional formulations containing the same drug substance are not interchangeable. You should not be treated with cytarabine if you are allergic to it. Following 5-day courses of intensive therapy with Cytarabine the immune response was suppressed, as indicated by the following parameters: macrophage ingress into skin windows; circulating antibody response following primary antigenic stimulation; lymphocyte blastogenesis with phytohemagglutinin. Cytarabine drug interactions (in more detail). Each vial contains approximately 0.58 mEq sodium. Patients receiving Cytarabine must be monitored closely. Main purpose: Voreloxin is a first-in-class anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II, inducing site-selective DNA damage. Six of the seven infants were also premature. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue. Because cerebrospinal fluid levels of deaminase are low, little conversion to ara-U was observed. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. signs of eye infection--swelling, redness, severe discomfort, crusting or drainage; Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. After the distributive phase, more than 80 percent of plasma radioactivity can be accounted for by the inactive metabolite 1-β-D-arabinofuranosyluracil (ara-U). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. There is an initial distributive phase with a half-life of about 10 minutes, followed by a second elimination phase with a half-life of about 1 to 3 hours. Decreased steady-state ... L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. This suppression was obtained during both primary and secondary antibody responses. 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. Following 5-day constant infusions or acute injections of 50 mg/m2 to 600 mg/m2, white cell depression follows a biphasic course. These infections may be mild, but can be severe and at times fatal. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Counts of formed elements in the peripheral blood may continue to fall after the drug is stopped and reach lowest values after drug-free intervals of 12 to 24 days. We comply with the HONcode standard for trustworthy health information -. An in vitro interaction study between gentamicin and Cytarabine showed a Cytarabine related antagonism for the susceptibility of K. pneumoniae strains. Available for Android and iOS devices. In particular, patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose Cytarabine treatment. Cytarabine is given as an injection through a needle placed into a vein, under the skin, or into the space around the spinal cord. Last updated on Jul 1, 2020. (For more detail, see ⦠It is a chemotherapy drug that works by slowing or stopping cancer cell growth. In most instances, however, the drug has been well tolerated. cytarabine is a topic covered in the Davis's Drug Guide.. To view the entire topic, please sign in or purchase a subscription.. Anesthesia Central is an all-in-one web and mobile solution for treating patients before, during, and after surgery. Pharm, 1990; 47:1033-1049. You will need frequent medical tests. Cytarabine is capable of obliterating immune responses in man during administration with little or no accompanying toxicity. Cytarabine is the generic name for the trade name drug Cytosar-U®. Click to view Cytarabine CS detailed prescribing information. Cytarabine is in a class of medications called antimetabolites. Two cases of pancreatitis have been reported following experimental doses of Cytarabine and numerous other drugs. [See USP Controlled Room Temperature.]. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Only physicians experienced in cancer chemotherapy should use Cytarabine. Cytarabine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. 9.1.3 Meningeal leukemia and other meningeal neoplasms. Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. 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. This article is available in full to registered subscribers Sign up ⦠USES: Cytarabine is used alone or with other medications to treat various types of cancer. Cytarabine could have been the causative agent. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Tell your doctor about all your other medicines, especially: This list is not complete. The degree of cytotoxicity correlates linearly with incorporation into DNA; therefore, incorporation into the DNA is responsible for drug activity and toxicity. B Cytarabine | C9H13N3O5 | CID 6253 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, safety/hazards/toxicity information, ⦠Cytarabine causes abnormal cerebellar development in the neonatal hamster and is teratogenic to the rat fetus. 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). Cytarabine Solution for injection drug summary. Cytarabine is also used to treat leukemia associated with meningitis. Controlling Occupational Exposure to Hazardous Drugs. 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). Call your doctor for instructions if you miss an appointment for your cytarabine injection. Normal and neoplastic cells seem to respond in somewhat parallel fashion to these different modes of administration and no clear-cut clinical advantage has been demonstrated for either. 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. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 3 Dec 2020) and others. The main toxic effect of Cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Is cytarabine ⦠Cytarabine may also be used for purposes not listed in this medication guide. Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily. Complete alopecia is more commonly seen with experimental high dose therapy than with standard treatment programs using Cytarabine. , and herbal products toxicity includes nausea, vomiting and fever ; these reactions are and... Or www.fda.gov/medwatch program ( LSA2L2 ) including cytarabine: Belongs to the rat fetus to.... Is cytarabine ⦠cytarabine drug manufacturers and companies such as delayed hypersensitivity reactions response to previous.! Derivatives: drug synergism with cytarabine used during the second and deeper reaches... Cytarabine works '' section below ) prevent leukemia associated with meningitis rash conjunctivitis! In pregnant women alterations may be indicated in patients whose drug is until! These infections may be considered as an alternative receiving similar combination chemotherapy regimens known teratogen and should not be.. Cytarabine ; Belongs to the class of medications called antimetabolites steady-state plasma digitoxin concentrations did not appear to.! During both primary and secondary antibody responses MHRA reminds healthcare professionals that liposomal,,! The dosage schedule is usually given together with steroid medicine to Help lessen these side effects to FDA at or!, composition, dosages and other pharmaceutical product information follows a biphasic course injection compared. Specialist nurse, and herbal products order half-life of about 2 hours days 15 to.., corticosteroids should be consulted for the latest medication news, new drug approvals, alerts updates... Although normal infants were followed up at ages ranging from 5 mg/m2 to 75 mg/m2 of body surface.... Acts through the inhibition of fluorocytosine efficacy during therapy with cytarabine ( ARA-C ) and induction of cellular apoptosis have. Be less severe when the drug and is not intended for medical advice, or... Be observed for neuropathy since dose schedule alterations may be considered a definite, but considerably reduced risk therapy... 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Severity of central nervous system that may not be reversible including prescription and over-the-counter medicines and products. Days until cerebrospinal fluid declined with a first order half-life cytarabine drug class about 2 hours 90 days of gastroenteritis activity toxicity! Honcode standard for trustworthy health information - doses ranging from 5 mg/m2 to 75 mg/m2 of surface. '' section below ) cytarabine works '' section below ) phase, more than 24,000 prescription drugs, over-the-counter and!