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Depocyt

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Uses

DepoCyt® (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis.

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History

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Other Information

DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, for intrathecal administration. The chemical name of cytarabine is 4-amino-1 -β-D-arabinofuranosyl-2(1H)-pyrimidinone, and is also known as cytosine arabinoside . It has a molecular formula of C9H13N3O5, and a molecular weight 243.22 g/mol. Cytarabine has the following structural formula:

Molecular structure

DepoCyt is available as a single-dose vial containing 50 mg/5 mL (10 mg/mL) of cytarabine. DepoCyt is formulated as a sterile, non-pyrogenic, white to off-white suspension of cytarabine liposomes in 0.9% w/v sodium chloride in water for injection. Each mL contains 10 mg cytarabine, 4.4 mg cholesterol, 1.2 mg triolein, 5.7 mg dioleoylphosphatidylcholine (DOPC), and 1.0 mg dipalmitoylphosphatidylglycerol (DPPG). DepoCyt is preservative-free. The pH of the product falls within the range from 5.5 to 8.5.

Liposome drug products may behave differently from nonliposome drug products. DepoCyt (cytarabine liposome injection) is not equivalent to, and cannot be substituted for, other drug products containing cytarabine.

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Depocyt Manufacturers

  • Sigma-tau Pharmaceuticals, Inc.
    Depocyt | Sigma-tau Pharmaceuticals, Inc.
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    Depocyt | Sigma-tau Pharmaceuticals, Inc.

    Depocyt | Sigma-tau Pharmaceuticals, Inc.
    2.1 Preparation and Administration Precautions

    DepoCyt is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be used in handling DepoCyt. The use of gloves is recommended. If DepoCyt suspension contacts the skin, wash immediately with soap and water. If it contacts mucous membranes, flush thoroughly with water.

    2.2 Preparation and Administration

    No further reconstitution or dilution is required. DepoCyt particles have a tendency to settle with time. Vials of DepoCyt should be allowed to warm to room temperature and gently agitated or inverted to re-suspend the particles immediately prior to withdrawal from the vial. Avoid aggressive agitation.

    DepoCyt should be withdrawn from the vial immediately before administration. DepoCyt is a single dose vial and does not contain any preservative. DepoCyt should be used within 4 hours of withdrawal from the vial. Unused portions of each vial should be discarded properly [see How Supplied/ Storage and Handling (16)]. Do not save any unused portions for later administration. Do not mix DepoCyt with any other medications.

    2.3 Dosing Precautions

    In-line filters must not be used when administering DepoCyt. DepoCyt is administered directly into the cerebrospinal fluid (CSF) via an intraventricular reservoir or by direct injection into the lumbar sac. DepoCyt should be injected slowly over a period of 1-5 minutes. Following drug administration by lumbar puncture, the patient should be instructed to lie flat for 1 hour. Patients should be observed by the physician for immediate toxic reactions.

    2.4 Dosing Regimen

    For the treatment of lymphomatous meningitis, DepoCyt 50 mg (one vial of DepoCyt) is recommended to be given according to the following schedule:

    Induction therapy DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar
    puncture) every 14 days for 2 doses (weeks 1 and 3). Consolidation therapy DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar
    puncture) every 14 days for 3 doses (weeks 5, 7 and 9) followed by 1
    additional dose at week 13. Maintenance DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar
    puncture) every 28 days for 4 doses (weeks 17, 21, 25 and 29).

    Patients should be started on dexamethasone 4 mg twice a day either by mouth or intravenously for 5 days beginning on the day of DepoCyt injection.

    If drug related neurotoxicity develops, the dose should be reduced to 25 mg. If it persists, treatment with DepoCyt should be discontinued.

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