Cytarabine
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
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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.See full prescribing information for complete Boxed Warning.
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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)
There is limited information regarding Cytarabine FDA-Labeled Indications and Dosage (Adult) in the drug label.
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
There is limited information regarding Cytarabine Contraindications in the drug label.
Warnings
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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.See full prescribing information for complete Boxed Warning.
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There is limited information regarding Cytarabine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cytarabine Clinical Trials Experience in the drug label.
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.