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DepoCyt

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DepoCyt

DepoCyt

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Preparation of DepoCyt® (cytarabine liposome injection)

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 (see Handling And Disposal). DepoCyt particles are denser than the diluent and 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. No further reconstitution or dilution is required.

DepoCyt Administration

DepoCyt should be withdrawn from the vial immediately before administration. DepoCyt is a single-use 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 Handling And Disposal). Do not save any unused portions for later administration. Do not mix DepoCyt with any other medications.

In-line filters must not be used when administering DepoCyt. DepoCyt is administered directly into the 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.

Patients should be started on dexamethasone 4 mg bid either PO or IV for 5 days beginning on the day of DepoCyt injection.

DepoCyt must only be administered by the intrathecal route.

Further dilution of DepoCyt is not recommended.

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).

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

Handling And Disposal

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-5 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

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

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

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

Do not use beyond expiration date printed on the label.

For additional information, contact Sigma-Tau Pharmaceuticals, Inc., at: 866-792-5172

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 200 165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. NIH [2002]. 1999 recommendations for the safe handling of cytotoxic drugs. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NIH Publication No. 92- 2621.

4. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs.

5. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Manufactured by: Pacira Pharmaceuticals Inc. San Diego, CA 92121. Distributed by: Sigma-Tau Pharmaceuticals, Inc. Gaithersburg, MD 20878. January 2011

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

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