Cytarabine 20 mg/mL
CYTARABINE · INJECTION, SOLUTION · Hospira, Inc.
Cytarabine is a chemotherapy medication given as an injection into the fluid surrounding the spinal cord to treat certain types of cancer, particularly leukemias and lymphomas that affect the central nervous system. This drug works by interfering with cancer cell growth and is typically used as part of a comprehensive cancer treatment plan.
Key Facts
- Brand Name
- Cytarabine
- Generic Name
- CYTARABINE
- NDC Code (Product)
61703-305- Manufacturer
- Hospira, Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRATHECAL, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA071868
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 06/04/1990
Recall History
Mylan Institutional LLC
Presence of Particulate Matter
Infusion Options, Inc.
Lack of Assurance of Sterility
Ben Venue Laboratories Inc
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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. Intrathecal administration of Cytarabine Injection is indicated in the prophylaxis and treatment of meningeal leukemia.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 …
Warnings
WARNINGS ( 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 di…
Contraindications
CONTRAINDICATIONS Cytarabine is contraindicated in those patients who are hypersensitive to the drug.
Drug Interactions
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 reevaluation 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.
Adverse Reactions
ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is Cytarabine used for?
Cytarabine is a chemotherapy medication given as an injection into the fluid surrounding the spinal cord to treat certain types of cancer, particularly leukemias and lymphomas that affect the central nervous system. This drug works by interfering with cancer cell growth and is typically used as part of a comprehensive cancer treatment plan.
Is Cytarabine a controlled substance?
Cytarabine is not classified as a controlled substance by the DEA.
What is the generic name for Cytarabine?
The generic name for Cytarabine is CYTARABINE. There are 3 other brand versions of CYTARABINE.
What is the NDC code for Cytarabine 20 mg/mL?
The NDC (National Drug Code) for Cytarabine 20 mg/mL is 61703-305, listed by Hospira, Inc..