CYTARABINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cytarabine (UNII: 04079A1RDZ) (cytarabine - UNII:04079A1RDZ)

Available from:

Sagent Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. 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 (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug.

Product summary:

Cytarabine Injection is available as follows: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Do not refrigerate. Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYTARABINE- CYTARABINE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
CYTARABINE INJECTION
(FOR INTRAVENOUS, INTRATHECAL AND SUBCUTANEOUS USE ONLY)
SAGENT
Rx only
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 judgement or beginning treatment, the
physician
should be familiar with the following text.
DESCRIPTION
Cytarabine Injection, an antineoplastic, is a sterile solution of
cytarabine for intravenous,
intrathecal or subcutaneous administration. Each mL contains 100 mg
cytarabine USP,
in 2 g per 20 mL (100 mg per mL) single dose vial and the following
inactive ingredients:
water for injection q.s. When necessary the pH is adjusted with
hydrochloric acid and/or
sodium hydroxide to a pH of 7.7.
Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The
structural formula is:
Cytarabine is an odorless, white to off-white crystalline powder which
is freely soluble in
®
water and slightly soluble in alcohol and in chloroform.
CLINICAL PHARMACOLOGY
CELL CULTURE STUDIES
Cytarabine is cytotoxic to a wide variety of proliferating mammalian
cells in culture. It
exhibits cell phase specificity, primarily killing cells undergoing
DNA synthesis (S-phase)
and under certain conditions blocking the progression of cells from
the G phase to the
S-phase. Although the mechanism of action is not completely
understood, it appears
that cytarabine acts through