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DepoCyt

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DepoCyt

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DEPOCYT®
(cytarabine liposome injection) 50 mg Vial

For Intrathecal Use Only

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 4amino-1 -β-D-arabinofuranosyl-2(1H)-pyrimidinone, also known as cytosine arabinoside (C9H13N3O5, molecular weight 243.22).

DEPOCYT® (cytarabine) Structural Formula Illustration

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

Artist’s rendition of a DepoCyt particle -llustration

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, 4.4 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.

What are the possible side effects of cytarabine liposomal (DepoCyt)?

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; difficulty breathing; swelling of the lips, face, or tongue; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; unusual bruising or bleeding; black, bloody or tarry stools; or fever, chills, sore throat, or signs of infection); or
  • chemical arachnoiditis (a syndrome characterized by...

Read All Potential Side Effects and See Pictures of DepoCyt »

What are the precautions when taking cytarabine liposome injection (DepoCyt)?

Before using cytarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain infection (e.g., bacterial/fungal/viral meningitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous chemotherapy, previous radiation therapy.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or...

Read All Potential Precautions of DepoCyt »

Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

DepoCyt - User Reviews

DepoCyt User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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