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DepoCyt
Overview
What is DepoCyt?
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 CHNO, and a molecular weight 243.22 g/mol. Cytarabine has the following structural formula:
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.
What does DepoCyt look like?
What are the available doses of DepoCyt?
Ready-to-use, single dose vial containing 50 mg/5 mL (10 mg/mL) of cytarabine liposome injection.
What should I talk to my health care provider before I take DepoCyt?
How should I use DepoCyt?
DepoCyt (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis.
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.
What interacts with DepoCyt?
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What are the warnings of DepoCyt?
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What are the precautions of DepoCyt?
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What are the side effects of DepoCyt?
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What should I look out for while using DepoCyt?
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.
Chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event in all clinical studies. If left untreated, chemical arachnoiditis may be fatal. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis. []
What might happen if I take too much DepoCyt?
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.
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.
How should I store and handle DepoCyt?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.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 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 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 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 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
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
DepoCyt (cytarabine liposome injection) is a sustained-release formulation of the active ingredient cytarabine designed for direct administration into the cerebrospinal fluid (CSF). Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP), which is the active metabolite. The mechanism of action is not completely understood, but it appears that ara-CTP acts primarily through inhibition of DNA polymerase. Incorporation into DNA and RNA may also contribute to cytarabine cytotoxicity. Cytarabine is cytotoxic to proliferating mammalian cells in culture.
Non-Clinical Toxicology
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.Chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event in all clinical studies. If left untreated, chemical arachnoiditis may be fatal. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis. []
When given concurrently the following drugs may interact with thiazide diuretics.
Potentiation of orthostatic hypotension may occur.
Dosage adjustment of the antidiabetic drug may be required.
Additive effect or potentiation.
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.
Intensified electrolyte depletion, particularly hypokalemia.
Possible decreased response to pressor amines but not sufficient to preclude their use.
Possible increased responsiveness to the muscle relaxant.
Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide.
In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.Therefore, when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, has been a common adverse event in all studies. If chemical arachnoiditis is suspected, exclude other inflammatory, infectious, or neoplastic conditions. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis [].
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, reduce subsequent doses of DepoCyt. If neurotoxicity persists, discontinue DepoCyt []
Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.
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. 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.
The following serious adverse reactions are described in greater detail in other sections of the label
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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