DepoCyt

Drug Description

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DEPOCYT®
(cytarabine liposome injection)
For Intrathecal Use Only
50 mg vial

WARNING

DepoCyt® (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone (see WARNINGS). Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).

DRUG DESCRIPTION

DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, encapsulated into multivesicular lipid-based particles. Chemically, cytarabine is 4-amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone, also known as cytosine arabinoside (C₉H₁₃N₃O₅, molecular weight 243.22).

DepoCyt® (cytarabine liposome injection) structural formula illustration

The following is an artist's rendition of a DepoCyt particle:

Nonconcentric vesicles, each with an internal, aqueous chamber containing encapsulated cytarabine solution, surrounded by a bilayer lipid membrane.

DepoCyt is available in 5 mL, ready-to-use, single-use vials containing 50 mg of cytarabine. DepoCyt is formulated as a sterile, non-pyrogenic, white to off-white suspension of cytarabine in Sodium Chloride 0.9% w/v in Water for Injection. DepoCyt is preservative-free. Cytarabine, the active ingredient, is present at a concentration of 10 mg/mL, and is encapsulated in the particles. Inactive ingredients at their respective approximate concentrations are cholesterol, 4.1 mg/mL; triolein, 1.2 mg/mL; dioleoylphosphatidylcholine (DOPC), 5.7 mg/mL; and dipalmitoylphosphatidylglycerol (DPPG), 1.0 mg/mL. The pH of the product falls within the range from 5.5 to 8.5.

Brand Name: DepoCyt
Generic Name: Cytarabine Liposome Injection

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