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. The human liver apparently detoxifies a substantial fraction of an administered dose. Available for Android and iOS devices. 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). Select one or more newsletters to continue. 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). Available for Android and iOS devices. cytarabine is a topic covered in the Davis's Drug Guide.. To view the entire topic, please sign in or purchase a subscription.. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or. This medication is classified as an "antimetabolite." 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. Frequent platelet and leucocyte counts and bone marrow examinations are mandatory. 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. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. If the symptoms of the syndrome are deemed treatable, corticosteroids should be contemplated as well as continuation of therapy with Cytarabine. Click to view Cytarabine CS detailed prescribing information. It is a chemotherapy drug that works by slowing or stopping cancer cell growth. 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. Then there is a rapid rise to above baseline in the next 10 days. Cytarabine is capable of obliterating immune responses in man during administration with little or no accompanying toxicity. Cytarabine: Belongs to the class of antimetabolites, pyrimidine analogues. Cytarabine is in a class of medications called antimetabolites. If experimental high dose therapy is used, do not use a preparation containing benzyl alcohol. Cytarabine is an antineoplastic anti-metabolite used in the treatment of several forms of leukemia including acute myelogenous leukemia and meningeal leukemia. 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. This cardiac toxicity may be schedule dependent. Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. Medically reviewed by Drugs.com. Cytarabine drug interactions (in more detail). In particular, patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose Cytarabine treatment. 9.1.3 Meningeal leukemia and other meningeal neoplasms. Suppression of antibody responses to E-coli-VI antigen and tetanus toxoid have been demonstrated. Complete alopecia is more commonly seen with experimental high dose therapy than with standard treatment programs using Cytarabine. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Drug type: Cytarabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This article is available in full to registered subscribers Sign up … Dosage ... cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction. Tell your doctor at once if you develop signs of infection. An in vitro interaction study between gentamicin and Cytarabine showed a Cytarabine related antagonism for the susceptibility of K. pneumoniae strains. Mfd. The frequency of administration varied from once a day for 4 days to once every 4 days. 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. Cytarabine can cause fetal harm when administered to a pregnant woman. Chemical stability studies were performed by ultraviolet assay on Cytarabine injection in infusion solutions. The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with Cytarabine. Usual Adult Dose for Acute Lymphocytic Leukemia: The literature and/or local protocol should be consulted.Use: Acute lymphocytic 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:-Only the preservative free formulation of this drug should be administered intrathecally.Use: Meningeal leukemia. Blindness occurred in two patients in remission whose treatment had consisted of combination systemic chemotherapy, prophylactic central nervous system radiation and intrathecal Cytarabine injection. Call your doctor for medical advice about side effects. It is not known whether this drug is excreted in human milk. 2.44). Cytarabine injection is not active orally. 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. We comply with the HONcode standard for trustworthy health information -. Call your doctor for instructions if you miss an appointment for your cytarabine injection. Two cases of congenital abnormalities have been reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Tell your doctor if you have feel confused or have any unusual thoughts or behavior. 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 – Written by Cerner Multum. 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. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked … After receiving an injection, you will be watched closely to make sure you do not have serious side effects. Version: 9.01. prednisone, triamcinolone, methotrexate, dexamethasone, Decadron, hydroxyurea, rituximab, Imbruvica, cyclophosphamide, Rituxan. This study suggests that in patients on Cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy. Cytarabine is in a class of medications called antimetabolites. Steady-state plasma digitoxin concentrations did not appear to change. Following rapid intravenous injection of Cytarabine labeled with tritium, the disappearance from plasma is biphasic. Chicago, IL 60631 (USA) Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. Cytarabine injection given intrathecally may cause systemic toxicity and careful monitoring of the hematopoietic system is indicated. 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. Is cytarabine … for Meitheal Pharmaceuticals Avoid being near people who are sick or have infections. 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. Used in the treatment of cancer. Reduced effectiveness of methotrexate. 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 Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. The degree of cytotoxicity correlates linearly with incorporation into DNA; therefore, incorporation into the DNA is responsible for drug activity and toxicity. Cytarabine is rapidly metabolized and is not effective orally; less than 20 percent of the orally administered dose is absorbed from the gastrointestinal tract. This problem tends to be less severe when the drug is infused. Because Cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis and reduced reticulocytes can be expected as a result of administration with Cytarabine. Cytarabine is usually given together with a … Protect from light. This may be due to potential competitive inhibition of its uptake. Not all possible drug interactions are listed here. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. Cytarabine causes abnormal cerebellar development in the neonatal hamster and is teratogenic to the rat fetus. Patients receiving Cytarabine must be monitored closely. Cytarabine is a potent bone marrow suppressant. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. You may report side effects to FDA at 1-800-FDA-1088. It usually occurs 6 to 12 hours following drug administration. Med J Australia, 1983; 1:426-428. 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. These infections may be mild, but can be severe and at times fatal. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. Cytarabine is in a class of medications called antimetabolites. Five infants were premature or of low birth weight. Cytarabine Solution for injection drug summary. Although the mechanism of action is not completely understood, it appears that Cytarabine acts through the inhibition of DNA polymerase. Isolated neurotoxicity has been reported. 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. Cytarabine is a pyrimidine analog and is incorporated into DNA; however, the primary action is inhibition of DNA polymerase resulting in decreased DNA synthesis and repair. Use the drug with caution and possibly at reduced dose in patients whose liver or kidney function is poor. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publications No. Each mL contains 20 mg Cytarabine, USP (20 mg per mL) in a single dose vial (100 mg per 5 mL). 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. Thereupon, a rapid rise to above baseline occurs in the next 10 days. Cytarabine will not treat a meningitis infection. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 3 Dec 2020) and others. We comply with the HONcode standard for trustworthy health information -. Procedures for proper handling and disposal of anti-cancer drugs should be considered. 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. Inhibition of ribonucleotide reductase by a new class of isoindole derivatives: drug synergism with cytarabine (Ara-C) and induction of cellular apoptosis. Pharm, 1990; 47:1033-1049. Cytarabine Pfizer(cytarabine): ... Drug Interactions . 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. However, it had no effect on already established delayed hypersensitivity reactions. 83-2621. Use in the second and third trimesters is safer but constitutes a considerable risk. Women of childbearing potential should be advised to avoid becoming pregnant. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue. Cytarabine also suppressed the development of cell-mediated immune responses such as delayed hypersensitivity skin reaction to dinitrochlorobenzene. Cytarabine will not treat an active meningitis infection that has already developed in the body. Other cancer drugs modify the base. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. INDICATIONS. Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. 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. (OSHA Work Practice Guidelines), Am J. Health- Syst Pharm, 1996; 53:1669-1685. Medscape - Acute myeloid leukemia dosing for Vyxeos (cytarabine/ daunorubicin liposomal), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. 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. Cytarabine is usually given together with steroid medicine to help lessen these side effects. Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity. The container closure is not made with natural rubber latex. Cytarabine can cause serious side effects on your brain or central nervous system that may not be reversible. Cytarabine Hospira(Cytarabine): Learn about Cytarabine Hospira's Dosage, Side Effects and indications HOW TO USE: This medication is usually given by injection into a vein by a health care professional. 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