July 29, 2016
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DepoCyt

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DepoCyt




Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

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.

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DepoCyt should be withdrawn from the vial immediately before administration.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]. Do not save any unused portions for later administration. Do not mix DepoCyt with any other medications.

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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

Ready-to-use, single dose vial containing 50 mg/5 mL (10 mg/mL) of cytarabine liposome injection.

Storage And Handling

DepoCyt® (cytarabine liposome injection) is supplied as a sterile, white to off-white suspension in 5 mL glass, single dose vials.

Store refrigerated at 2° to 8°C (36° to 46°F). Protect from freezing and avoid aggressive agitation.

Available in individual carton containing one ready to use vial. NDC 57665-331-01.

Do not use beyond expiration date printed on the label.

DepoCyt is a genotoxic drug. Follow special handling and disposal procedures [see REFERENCES].

REFERENCES

OSHA Hazardous Drugs. OSHA. [Accessed on November 4, 2014, from http://www.osha.gov/SLTC/hazardousdrugs/index.html].

Manufactured by: Pacira Pharmaceuticals, Inc., San Diego, CA 92121. Distributed by: Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/16/2016

Indications
Dosage
How Supplied

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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