Cytarabine

FDA label, Meitheal Pharmaceuticals Inc., intrathecal, effective 2024-04-08. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

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

Before making this judgment or beginning treatment, the physician should be familiar with the following text.

Handling and access

NIOSH hazardous drug

Table 1

NIOSH lists cytarabine as a hazardous drug. AHFS class: 10:00 antineoplastic agents.

  • The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.

Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.

Source: NIOSH List of Hazardous Drugs in Healthcare Settings, 2024December 2024, updates through Jul 17, 2025

Nucleoside Metabolic Inhibitor

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

Prepare this dose

Your numbers for cytarabine. Take vial strength, diluent, and limits from the label below.

Basis

Enter a dose to see draw volume, final concentration, and rates.

DOSAGE AND ADMINISTRATION Cytarabine injection is not active orally. The schedule and method of administration varies with the program of therapy to be used. Cytarabine injection may be given by intravenous infusion or injection, subcutaneously, or intrathecally (preservative free preparation only). 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. In the induction therapy of acute non-lymphocytic leukemia, the usual cytarabine dose in combination with other anticancer drugs is 100 mg/m 2 /day by continuous IV infusion (Days 1 to 7) or 100 mg/m 2 IV every 12 hours (Days 1 to 7).

Focal leukemic involvement of the central nervous system may not respond to intrathecal cytarabine injection and may better be treated with radiotherapy. Chemical Stability of Infusion Solutions Chemical stability studies were performed by HPLC on cytarabine injection in infusion solutions. 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.

Parenteral drugs should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit. If a precipitate has formed as a result of exposure to low temperatures, redissolve by warming up to 55°C for no longer than 30 minutes, under dry heat conditions, and shake until the precipitate has dissolved.

Drug interactions

Check cytarabine against a medication list
Label text (2 paragraphs)

Drug Interactions 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. Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative.

An in vitro interaction study between gentamicin and cytarabine showed a cytarabine related antagonism for the susceptibility of K. pneumoniae strains. 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. Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine. This may be due to potential competitive inhibition of its uptake.

Contraindications

Cytarabine injection is contraindicated in those patients who are hypersensitive to the drug.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

C

Likelihood score C: Probable cause of clinically apparent liver injury.

Cytarabine is a cytosine analogue and antineoplastic agent used largely in the therapy of acute leukemia. Cytarabine is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, but has only rarely been implicated in cases of clinically apparent acute liver injury with jaundice.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Cytarabine (NIDDK, public domain)Chapter updated Nov 3, 2017

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects See WARNINGS .

Lactation

Nursing mothers It is not known whether this drug is excreted in human milk. 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.

Breastfeeding (LactMed)

No information is available on the excretion of cytarabine into breastmilk. However, the drug has a short half-life of 2 to 3 hours after intravenous administration, so it should be eliminated from milk a day after intravenous administration. Very little information is available on the use of cytarabine during breastfeeding. In one case, a mother began breastfeeding her infant 3 weeks after receiving cytarabine, mitoxantrone and etoposide intravenously, with no apparent harm to her infant. After intrathecal administration of the liposomal formulation of cytarabine, drugs levels in plasma are barely detectable, and are unlikely to appear in milk in clinically relevant amounts.

Source: LactMed: Cytarabine (NICHD, public domain)Revised May 15, 2024

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

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