pharmacopeia
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/api/v1/drug/cytarabine

Boxed warning

Only physicians experienced in cancer chemotherapy should use cytarabine. 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. 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.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: DNA Polymerase Inhibitors; Nucleic Acid Synthesis Inhibitors.

DNA PolymeraseNucleic Acid Synthesis

Indications

Sourced from openFDA
  • Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.ICD-10: C95.90

Contraindications

Sourced from openFDA
  • Cytarabine is contraindicated in those patients who are hypersensitive to the drug.contraindicated

Dosage & administration

Sourced from openFDA

Cytarabine injection (non-preserved) can be administered by intravenous injection or infusion, subcutaneously, or intrathecally. However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Intrathecal use of cytarabine injection requires the use of single-dose, unpreserved solutions only. Cytarabine injection is not active orally. The schedule and method of administration varies with the program of therapy to be used. While cytarabine injection may be given by intravenous infusion or injection, or subcutaneously or intrathecally, THE PURPOSE OF THE PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF INTRAVENOUS INFUSIONS. 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. In most instances, however, the drug has been well tolerated. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. 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. 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.

Warnings & precautions

Sourced from openFDA

( See boxed WARNING ) Cytarabine is a potent bone marrow suppressant. 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 leucocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. 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). One case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported. This occurred immediately after the intravenous administration of cytarabine. 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 cytarabine dose schedules. 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.

Adverse reactions

Sourced from openFDA

Expected Reactions Because cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis and reduced reticulocytes can be expected as a result of administration with cytarabine. The severity of these reactions are dose and schedule dependent. Cellular changes in the morphology of bone marrow and peripheral smears can be expected. Following 5-day constant infusions or acute injections of 50 mg/m 2 to 600 mg/m 2 , white cell depression follows a biphasic course. Regardless of initial count, dosage level, or schedule, there is an initial fall starting the first 24 hours with a nadir at days 7 to 9. This is followed by a brief rise which peaks around the twelfth day. A second and deeper fall reaches nadir at days 15 to 24. Then there is a rapid rise to above baseline in the next 10 days. Platelet depression is noticeable at 5 days with a peak depression occurring between days 12 to 15. Thereupon, a rapid rise to above baseline occurs in the next 10 days. Infectious Complications Infection Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body may be associated with the use of cytarabine alone or in combination with other immunosuppressive agents following immunosuppressant doses that affect cellular or humoral immunity. These infections may be mild, but can be severe and at times fatal. The Cytarabine (Ara-C) Syndrome A cytarabine syndrome has been described by Castleberry. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise.

Use in specific populations

Sourced from openFDA

Pregnancy See WARNINGS . 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. Four of these had first trimester exposure. Five infants were premature or of low birth weight. Twelve of the 18 normal infants were followed up at ages ranging from six weeks to seven years, and showed no abnormalities. One apparently normal infant died at 90 days of gastroenteritis. Two cases of congenital abnormalities have been reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Both of these cases had first trimester exposure. There were seven infants with various problems in the neonatal period, including pancytopenia; transient depression of the WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased IgM levels and hyperpyrexia possibly due to sepsis. Six of the seven infants were also premature. The child with pancytopenia died at 21 days of sepsis. Therapeutic abortions were done in five cases. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue.

Overdosage

Sourced from openFDA

There is no antidote for cytarabine overdosage. Doses of 4.5 g/m 2 by intravenous infusion over 1 hour every 12 hours for 12 doses has caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m 2 have been administered by rapid intravenous infusion without apparent toxicity.

Approval history

Sourced from openFDA
  • Jun 4, 1990ANDAANDA071868Hospira
  • Aug 31, 1990ANDAANDA072168Hospira
  • Feb 28, 1994ANDAANDA072945Hospira
  • Nov 22, 1999ANDAANDA075383Hospira
  • Jan 15, 2004ANDAANDA076512Fresenius Kabi Usa
  • Aug 3, 2017NDANDA209401Jazz Pharms Therap
  • Nov 9, 2017ANDAANDA206190Meitheal
  • Jul 17, 2018ANDAANDA205696Meitheal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
60,668 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia7,90613%
  2. 2Off Label Use5,0898.4%
  3. 3Pyrexia4,2577.0%
  4. 4Neutropenia3,6966.1%
  5. 5Drug Ineffective3,1675.2%
  6. 6Sepsis3,0445.0%
  7. 7Thrombocytopenia2,9464.9%
  8. 8Disease Progression2,8114.6%
  9. 9Pneumonia2,4254.0%
  10. 10Death2,1873.6%
  11. 11Myelosuppression2,1333.5%
  12. 12Pancytopenia2,1193.5%
  13. 13Septic Shock1,9183.2%
  14. 14Nausea1,8683.1%
  15. 15Infection1,8663.1%

Literature

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Recent PubMed references pinned to Cytarabine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,743 ClinicalTrials.gov registrations naming Cytarabine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cytarabine work?
Mechanism-of-action classes: DNA Polymerase Inhibitors; Nucleic Acid Synthesis Inhibitors.
What is Cytarabine used for?
According to FDA labeling, Cytarabine carries indications including: Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cytarabine?
Cytarabine is classified as Pyrimidine analogues, Nucleoside Metabolic Inhibitor, DNA Polymerase Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Decreased RNA Integrity, Increased Cellular Death.
What are the brand names for Cytarabine?
Cytarabine is marketed under brand names including Vyxeos.
What are the contraindications for Cytarabine?
Cytarabine labeling lists contraindications including: Cytarabine is contraindicated in those patients who are hypersensitive to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for cytarabine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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