Cytarabine

Cytarabine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

Black Box Warning: See full prescribing information for complete Boxed Warning. ConditionName: 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 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.

Overview

Cytarabine is an antineoplastic agent that is FDA approved for the treatment of acute non-lymphocytic leukemia of adults and children, acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine injection is indicated for the prophylaxis and treatment of meningeal leukemia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include thrombophlebitis, rash, hyperuricemia, anal inflammation, diarrhea, loss of apetite, nauseas, stomatitis, mouth ulceration, vomiting, decreased reticulocyte count, megaloblastic anemia, decreased liver function and fever..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Non-Lymphocytic Leukemia

• Induction: 100 mg/m2/day by continuous IV infusion (Days 1-7) or 100 mg/m2 IV every 12 hours (Days 1-7).

Acute Lymphocytic Leukemia

• Dosage: doses ranging from 5 mg/m2 to 75 mg/m2 of body surface area. The frequency of administration varied from once a day for 4 days to once every 4 days. The most frequently used dose was 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cytarabine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cytarabine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Cytarabine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cytarabine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cytarabine in pediatric patients.

Contraindications

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

Warnings

Black Box Warning: See full prescribing information for complete Boxed Warning. ConditionName: 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 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.

• 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 leukocyte 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 of the 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. Rarely, severe skin rash, leading to desquamation has been reported. Complete alopecia is more commonly seen with experimental high dose therapy than with standard cytarabine treatment programs. If experimental high dose therapy is used, do not use a cytarabine injection containing benzyl alcohol.

• Cases of cardiomyopathy with subsequent death has been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation.

• 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. The outcome of this syndrome can be fatal.

• Benzyl alcohol is contained in this product. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

• Two patients with childhood acute myelogenous leukemia who received intrathecal and intravenous cytarabine at conventional doses (in addition to a number of other concomitantly administered drugs) developed delayed progressive ascending paralysis resulting in death in one of the two patients.

Adverse Reactions

Clinical Trials Experience

Hematological Effects

• Anemia
• Leukopenia
• Thrombocytopenia
• Megaloblastosis
• Reduced reticulocytes

Infections

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.

Cytabarine Syndrome

Postmarketing Experience

There is limited information regarding Cytarabine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Cytarabine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cytarabine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cytarabine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cytarabine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cytarabine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cytarabine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cytarabine in geriatric settings.

Gender

There is no FDA guidance on the use of Cytarabine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cytarabine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cytarabine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cytarabine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cytarabine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cytarabine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Cytarabine Administration in the drug label.

Monitoring

There is limited information regarding Cytarabine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cytarabine and IV administrations.

Overdosage

There is limited information regarding Cytarabine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Cytarabine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cytarabine Mechanism of Action in the drug label.

Structure

There is limited information regarding Cytarabine Structure in the drug label.

Pharmacodynamics

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Pharmacokinetics

There is limited information regarding Cytarabine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cytarabine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cytarabine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cytarabine How Supplied in the drug label.

Storage

There is limited information regarding Cytarabine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cytarabine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Cytarabine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Cytarabine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cytarabine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.