Drug: DepoCyt

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). 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, 4.4 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.

Source: http://www.rxlist.com

The toxicity database consists of the observations made during Phase 1-4 studies. The most common adverse reactions in all patients and in patients with lymphoma are shown in Table 2 below. Arachnoiditis is an expected and well-documented side effect of both neoplastic meningitis and of intrathecal chemotherapy. The incidence of severe and life-threatening arachnoiditis in patients receiving DepoCyt was 19% (48/257) in all patients and 30% (10/33) in patients with lymphomatous meningitis. The incidence of symptoms possibly reflecting meningeal irritation are shown in Table 3. In the early dose-finding study, chemical arachnoiditis was observed in 100% of cycles without dexamethasone prophylaxis. When concurrent dexamethasone was administered, chemical arachnoiditis was observed in 33% of cycles. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION). Table 2: Incidence of adverse reactions occurring in > 10% of patients in all Phase 1-4 adult study patients and in patients with lymphomatous meningitis receiving DepoCyt 50 mg or an active comparator
System Organ Class / Preferred Term All DepoCyt (N=257) Lymphoma Depo Cyt (N=33) Ara-C (N=28) Nervous System Disorders   Headache NOS 144(56%) 17(52%) 9(32%)   Arachnoiditis   108(42%) 14(42%) 10(36%)   Confusion   86(33%) 12(36%) 3(11%)   Gait abnormal NOS 60(23%) 7(21%) 8(29%)   Convulsions NOS 52(20%) 7(21%) 1(4%)   Dizziness NOS 47(18%) 7(21%) 6(21%)   Memory impairment 36(14%) 4(12%) 1(4%)   Hypoaesthesia 26(10%) 4(12%) 3(11%)   Tremor 22(9%) 5(15%) 5(18%)   Peripheral neuropathy NOS 9(4%) 4(12%) 1(4%)   Syncope 8(3%) 00%) 3(11%)   Neuropathy NOS 7(3%) 3(9%) 3(11%)   Peripheral sensory neuropathy 7(3%) 2(6%) 3(11%)   Reflexes abnormal 7(3%) 0(0%) 3(11%) General Disorders and Administration Site Conditions   Weakness 103(40%) 13(39%) 15(54%)   Pyrexia 81(32%) 15(45%) 12(43%)   Fatigue 64(25%) 9(27%) 13(46%)   Lethargy 41(16%) 4(12%) 4(14%)   Death NOS   35(14%) 9(27%) 5(18%)   Pain NOS 35(14%) 3(9%) 5(18%)   Oedema peripheral 27(11%) 6(18%) 7(25%)   Fall 12(5%) 0(0%) 3(11%)   Mucosal inflammation NOS 8(3%) 4(12%) 2(7%)   Oedema NOS 6(2%) 1(3%) 6(21%) Gastrointestinal Disorders   Nausea 117(46%) 11(33%) 15(54%)   Vomiting NOS 112(44%) 11(33%) 9(32%)   Constipation 64(25%) 8(24%) 7(25%)   Diarrhoea NOS 31(12%) 9(27%) 9(32%)   Abdominal pain NOS 22(9%) 5(15%) 4(14%)   Dysphagia 20(8%) 3(9%) 3(11%)   Haemorrhoids 8(3%) 0(0%) 3(11%) Musculoskeletal and Connective Tissue Disorders   Back pain 61(24%) 7(21%) 5(18%)   Pain in limb 39(15%) 4(12%) 8(29%)   Neck pain 36(14%) 5(15%) 3(11%)   Arthralgia 29(11%) 3(9%) 4(14%)   Neck stiffness 28(11%) 2(6%) 4(14%)   Muscle weakness NOS 25(10%) 5(15%) 2(7%) Psychiatric Disorders   Insomnia 35(14%) 6(18%) 7(25%)   Agitation 26(10%) 5(15%) 2(7%)   Depression 21(8%) 6(18%) 4(14%)   Anxiety 17(7%) 1(3%) 3(11%) Infections and Infestations   Urinary tract infection NOS 35(14%) 6(18%) 5(18%)   Pneumonia NOS 16(6%) 2(6%) 3(11%) Metabolism and Nutrition Disorders   Dehydration 33(13%) 6(18%) 3(11%)   Appetite decreased NOS 29(11%) 4(12%) 3(11%)   Hyponatraemia 18(7%) 4(12%) 1(4%)   Hypokalaemia 17(7%) 5(15%) 2(7%)   Hyperglycaemia 15(6%) 4(12%) 2(7%)   Anorexia 14(5%) 1(3%) 5(18%) Investigations   Platelet count decreased  8(3%) 00%) 3(11%) Renal and Urinary Disorders   Incontinence NOS 19(7%) 3(9%) 5(18%)   Urinary retention 14(5%) 00%) 3(11%) Respiratory, Thoracic and Mediastinal Disorders   Dyspnoea NOS 25(10%) 4(12%) 6(21%)   Cough 17(7%) 3(9%) 6(21%) Eye Disorders   Vision blurred 29(11%) 4(12%) 4(14%) Blood and Lymphatic Disorders   Anaemia NOS 31(12%) 6(18%) 5(18%)   Thrombocytopenia 27(11%) 8(24%) 9(32%)   Neutropenia 26(10%) 12(36%) 7(25%) Skin and Subcutaneous Tissue Disorders   Contusion 6(2%) 1(3%) 3(11%)   Pruritus NOS 6(2%) 00%) 4(14%)   Sweating increased 6(2%) 1(3%) 3(11%) Vascular Disorders   Hypotension NOS 21(8%) 6(18%) 2(7%)   Hypertension NOS 15(6%) 5(15%) 1(4%) Ear and Labyrinth Disorders   Hypoacusis 15(6%) 6(18%) 3(11%) Cardiac Disorders    Tachycardia NOS 22(9%) 00%) 5(18%) Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps)   Diffuse Large B-Cell Lymphoma NOS 10%) 1(3%) 3(11%) Table 3: Incidence of adverse reactions possibly reflecting meningeal irritation occurring in > 10% of all studied adult patients receiving DepoCyt 50 mg or an active comparator*
System Organ Class / Preferred Term DepoCyt
(N=257) MTX
(N=78) Ara-C
(N=28) Nervous System Disorders Headache NOS 145 (56%) 33(42%) 9(32%) Arachnoiditis 108 (42%) 15(19%) 10(36%) Convulsions NOS 56 (22%) 11(14%) 1(4%) Gastrointestinal Disorders Nausea 117 (46%) 24(31%) 15(54%) Vomiting NOS 112 (44%) 22(28%) 9(32%) Musculoskeltal and Connective Tissue Disorders Back pain 61 (24%) 15(19%) 5(18%) Neck pain 36 (14%) 6(8%) 3(11%) Neck stiffness 28 (11%) 1(1%) 4(14%) General Disorders and Administration Site Conditions Pyrexia 81 (32%) 15(19%) 12(43%) * Hydrocephalus acquired, CSF pleocytosis and meningism occurred in ≤ 10% of all studied adult patients receiving DepoCyt or an active comparator Read the DepoCyt (cytarabine liposome injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

No formal drug interaction studies of DepoCyt and other drugs were conducted. Concomitant administration of DepoCyt with other antineoplastic agents administered by the intrathecal route has not been studied. With intrathecal cytarabine and other cytotoxic agents administered intrathecally, enhanced neurotoxicity has been associated with coadministration of drugs. Laboratory Test Interactions Since DepoCyt particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examinations following DepoCyt administration.Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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

Source: http://www.rxlist.com

DepoCyt® (cytarabine liposome injection) is contraindicated in patients who are hypersensitive to cytarabine or any component of the formulation, and in patients with active meningeal infection.Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No overdosages with DepoCyt® (cytarabine liposome injection) have been reported. An overdose with DepoCyt may be associated with severe chemical arachnoiditis including encephalopathy. In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered. One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving an intraventricular dose of DepoCyt (see WARNINGS). This patient, however, was also receiving concomitant whole brain irradiation and had previously received intraventricular methotrexate. There is no antidote for overdose of intrathecal DepoCyt or unencapsulated cytarabine released from DepoCyt. Exchange of CSF with isotonic saline has been carried out in a case of intrathecal overdose of free cytarabine, and such a procedure may be considered in the case of DepoCyt overdose. Management of overdose should be directed at maintaining vital functions.

Source: http://www.rxlist.com

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

Source: http://www.rxlist.com

General Precautions DepoCyt® (cytarabine liposome injection) has the potential of producing serious toxicity (see BOXED WARNING). All patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION). Toxic effects may be related to a single dose or to cumulative administration. Because toxic effects can occur at any time during therapy (although they are most likely to occur within 5 days of drug administration), patients receiving intrathecal therapy with DepoCyt should be monitored continuously for the development of neurotoxicity. If patients develop neurotoxicity, subsequent doses of DepoCyt should be reduced, and DepoCyt should be discontinued if toxicity persists. Some patients with neoplastic meningitis receiving treatment with DepoCyt may require concurrent radiation or systemic therapy with other chemotherapeutic agents; this may increase the rate of adverse events. Anaphylactic reactions following intravenous administration of free cytarabine have been reported. Although significant systemic exposure to free cytarabine following intrathecal treatment is not expected, some effect on bone marrow function cannot be excluded. Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leukopenia, thrombocytopenia, and anemia. Accordingly, careful monitoring of the hematopoietic system is advised. Transient elevations in CSF protein and white blood cells have been observed in patients following DepoCyt administration and have also been noted after intrathecal treatment with methotrexate or cytarabine. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, mutagenicity or impairment of fertility studies have been conducted with DepoCyt. The active ingredient of DepoCyt, cytarabine, was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and SCE in human leukocytes) and in vivo (chromosome aberrations and SCE assay in rodent bone marrow, mouse micronucleus assay). Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro . Cytarabine was clastogenic to meiotic cells; a dose-dependent increase in sperm-head abnormalities and chromosomal aberrations occurred in mice given IP cytarabine. Impairment of Fertility: No studies assessing the impact of cytarabine on fertility are available in the literature. Because the systemic exposure to free cytarabine following intrathecal treatment with DepoCyt was negligible, the risk of impaired fertility after intrathecal DepoCyt is likely to be low. Pregnancy Pregnancy Category D (see WARNINGS). Nursing Mothers It is not known whether cytarabine is excreted in human milk following intrathecal DepoCyt administration. The systemic exposure to free cytarabine following intrathecal treatment with DepoCyt was negligible. Despite the low apparent risk, because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, the use of DepoCyt is not recommended in nursing women. Pediatric Use The safety and efficacy of DepoCyt in pediatric patients has not been established.Last reviewed on RxList: 8/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Senior Healthcare Matters an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically DepoCyt. Find what medications you are taking today.