Cytarabine

ara-C

deoxycytidine kinase cytidine deaminase

ara-U ara-CMP

dCMP kinase

ara-CDP

ara-CTP

NDP kinase

ara-UMP

dCMP deaminase

NH2

N CH

CH C O

C

N

H H

H

HO

HO

H

HOCH2 O

Trade Names

Cytosine arabinoside, Ara-C

Classification

Antimetabolite

Category

Chemotherapy drug

Drug Manufacturer

Bedford Laboratories

Mechanism of Action

Deoxycytidine analog originally isolated from the sponge

Cryptothethya crypta .

Cell cycle–specific with activity in the S-phase.

Requires intracellular activation to the nucleotide metabolite ara-CTP.

Antitumor activity of cytarabine is determined by a balance between

intracellular activation and degradation and the subsequent formation

of cytotoxic ara-CTP metabolites.

Incorporation of ara-CTP into DNA resulting in chain termination

and inhibition of DNA synthesis and function.

Ara-CTP inhibits several DNA polymerases _, , and _, which then

interferes with DNA chain elongation, DNA synthesis, and DNA

repair.

Ara-CTP inhibits the enzyme ribonucleotide reductase, resulting in

decreased levels of essential deoxyribonucleotides required for DNA

synthesis and function.

Mechanism of Resistance

Decreased activation of drug through decreased expression of the

anabolic enzyme deoxycytidine kinase.

Increased breakdown of drug by the catabolic enzymes, cytidine

deaminase and deoxycytidylate (dCMP) deaminase.

Decreased transport of drug into cells.

Increased expression of CTP synthetase activity resulting in

increased concentrations of competing physiologic nucleotide substrate

dCTP.

Absorption

Poor oral bioavailability (~20%) as a result of extensive deamination

within the GI tract.

Distribution

Rapidly cleared from the bloodstream after IV administration. Distributes

rapidly into tissues and total body water. Crosses the blood-brain barrier with

CSF levels reaching 20%–40% of those in plasma. Binding to plasma proteins

has not been well characterized.

Metabolism

Undergoes extensive metabolism, with approximately 70%–80% of

drug being recovered in the urine as the ara-U metabolite within 24 hours.

Deamination occurs in liver, plasma, and peripheral tissues. The principal

enzyme involved in drug catabolism is cytidine deaminase, which converts

ara-C into the inactive metabolite ara-U. dCMP-deaminase converts ara-CMP

into ara-UMP, and this represents an additional catabolic pathway of the

drug. The terminal elimination half-life is 2–6 hours. The half-life of ara-C

in CSF is somewhat longer, ranging from 2 to 11 hours, due to the relatively

low activity of cytidine deaminase present in CSF.

Indications

Acute myelogenous leukemia.

Acute lymphocytic leukemia.

Chronic myelogenous leukemia.

Leptomeningeal carcinomatosis.

Non-Hodgkin’s lymphoma.

DosageRange

Several different doses and schedules have been used:

Standard dose: 100 mg/m 2 /day IV on days 1–7 as a continuous IV

infusion, in combination with an anthracycline as induction chemotherapy

for AML.

High-dose: 1.5–3.0 g/m 2 IV q 12 hours for 3 days as a high-dose,

intensification regimen for AML.

SC: 20 mg/m 2 SC for 10 days per month for 6 months, associated

with IFN-_ for treatment of CML.

Intrathecal: 10–30 mg intrathecal (IT) up to three times weekly in the

treatment of leptomeningeal carcinomatosis secondary to leukemia

or lymphoma.

Drug Interaction 1

Gentamicin—Cytarabine antagonizes the efficacy of gentamicin.

Drug Interaction 2

5-Fluorocytosine—Cytarabine inhibits the efficacy of 5-fluorocytosine by

preventing its cellular uptake.

Drug Interaction 3

Digoxin—Cytarabine decreases the oral bioavailability of digoxin, thereby

decreasing its efficacy. Digoxin levels should be monitored closely while on

therapy.

Drug Interaction 4

Alkylating agents, cisplatin, and ionizing radiation—Cytarabine enhances

the cytotoxicity of various alkylating agents (cyclophosphamide, carmustine),

cisplatin, and ionizing radiation by inhibiting DNA repair mechanisms.

Concurrent use of high-dose cytarabine and cisplatin may increase risk of

ototoxicity.

Drug Interaction 5

Methotrexate—Pretreatment with methotrexate enhances the formation

of ara-CTP metabolites resulting in enhanced cytotoxicity.

Drug Interaction 6

Fludarabine, hydroxyurea—Pretreatment with fludarabine and/or

hydroxyurea potentiates the cytotoxicity of cytarabine by enhancing the formation

of cytotoxic ara-CTP metabolites.

Drug Interaction 7

GM-CSF, interleukin-3—Cytokines including GM-CSF and interleukin-3

enhance cytarabine-mediated apoptosis mechanisms.

Drug Interaction 8

L-Asparaginase—Increased risk of pancreatitis when L-asparaginase is

given before cytarabine.

Special Considerations

Monitor CBCs on a regular basis during therapy.

Use with caution in patients with abnormal liver and/or renal function.

Dose modification should be considered in this setting as

patients are at increased risk for toxicity. Monitor hepatic and renal

function during therapy.

Alkalinization of the urine (pH _7.0), allopurinol, and vigorous IV

hydration are recommended to prevent tumor lysis syndrome in

patients with acute myelogenous leukemia.

High-dose therapy should be administered over a 1- to 2-hour period.

Conjunctivitis is observed with high-dose therapy as the drug is

excreted in tears. Patients should be treated with hydrocortisone eye

drops (2 drops OU qid for 10 days) on the night before the start of

therapy.

Pregnancy category D.

Toxicity 1

Myelosuppression is dose-limiting. Leukopenia and thrombocytopenia

are common. Nadir usually occurs by days 7–10, with recovery by days 14–21.

Megaloblastic anemia has also been observed.

Toxicity 2

Nausea and vomiting. Mild to moderate emetogenic agent with increased

severity observed with high-dose therapy. Anorexia, diarrhea, and mucositis

usually occur 7–10 days after therapy.

Toxicity 3

Cerebellar ataxia, lethargy, and confusion. Neurotoxicity develops in up

to 10% of patients. Onset usually 5 days after drug treatment and lasts up to

1 week. In most cases, CNS toxicities are mild and reversible. Risk factors for

neurotoxicity include high-dose therapy, age older than 40, abnormal renal

function with serum creatinine 1.2 mg/dL, and abnormal liver function.

Toxicity 4

Transient hepatic dysfunction with elevation of serum transaminases and

bilirubin. Most often associated with high-dose therapy.

Toxicity 5

Acute pancreatitis.

Toxicity 6

Ara-C syndrome. Described in pediatric patients and represents an allergic

reaction to cytarabine

Characterized by fever, myalgia, malaise, bone

pain, maculopapular skin rash, conjunctivitis, and occasional chest pain.

Usually occurs within 12 hours of drug infusion. Steroids appear to be effective

in treating and/or preventing the onset of this syndrome.

Toxicity 7

Pulmonary complications include non-cardiogenic pulmonary edema,

acute respiratory distress, and Streptococcus viridans pneumonia. Observed

with high-dose therapy.

Toxicity 8

Erythema of skin, alopecia, and hidradenitis are usually mild and selflimited.

Hand-foot syndrome observed rarely with high-dose therapy.

Toxicity 9

Conjunctivitis and keratitis. Associated with high-dose regimens.

Toxicity 10

Seizures, alterations in mental status, and fever may be observed within

the first 24 hours after IT administration.