Adult Dosing

Lymphomatous meningitis

• Induction therapy: 50 mg IT (intraventricular or lumbar puncture) q2 wks x2 doses, during week 1 and 3
• Consolidation therapy: 50 mg IT (intraventricular or lumbar puncture) q2 wks x3 doses, during week 5, 7 and 9; and additional dose at week 13
• Maintenance therapy: 50 mg IT (intraventricular or lumbar puncture) q4 wks x4 doses, during week 17, 21, 25 and 29

• Start dexamethasone 4 mg bid either PO or IV for 5 days starting the day of liposomal cytarabine administration

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of lymphomatous meningitis

• Hypersensitivity to any of the ingredients of the product
• Patient with active meningeal infection
• Avoid pregnancy
• Breastfeeding

• Use cytarabine liposomal injection only under the supervision of physician experienced in intrathecal cancer chemotherapy
• Adequate diagnostic and treatment facilities must be available for management of complication
• Chemical arachnoiditis, a syndrome manifested by nausea, vomiting, headache and fever are the common adverse event and can be fatal if untreated
• Treat patients receiving cytarabine liposome concurrently with dexamethasone for mitigation of the symptoms related to chemical arachnoiditis

Neurologic Toxicity

• If neurologic toxicity occurs, reduce the dose to 25 mg. Discontinue if toxicity persists

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Use cytarabine liposomal injection only under the supervision of experienced physicians in intrathecal cancer chemotherapy [Black Box Warning]
• Adequate diagnostic and treatment facilities must be available for management of complication [Black Box Warning]
• Chemical arachnoiditis, a syndrome manifested by nausea, vomiting, headache and fever are the common adverse event and can be fatal if untreated [Black Box Warning]
• Co-administer dexamethasone to reduce the incidence and severity of chemical arachnoiditis [Black Box Warning]
• Infectious meningitis may be associated with the therapy. Hydrocephalus and seizures has been reported
• Patients receiving cytarabine liposome should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis [Black Box Warning]
• Therapy may cause myelopathy and other neurologic toxicity and may lead to permanent neurologic deficit. Risk of neurotoxicity increases on administration with other chemotherapeutic agents or with cranial/spinal irradiation
• CSF flow blockage may increases free cytarabine concentration in the CSF and increase risk of neurotoxicity
• Cases of CNS toxicity (eg persistent extreme somnolence, hemiplegia, visual disturbances including blindness which may be total and permanent, deafness and cranial nerve palsies) and sign and symptoms of peripheral neuropathy, such as pain, numbness, paresthesia, weakness, and impaired bowel and bladder control have been observed.
• Cauda Equina Syndrome a combination of neurological signs and symptoms have been reported
• Cytarabine liposome can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant
• Administer dexamethasone concomitantly to mitigate the symptoms of chemical arachnoiditis
• Toxic effects may occur at any time during therapy monitor for the development of neurotoxicity; if toxicity occur discontinue the therapy
• Neoplastic meningitis patient on cytarabine liposome may require concomitant radiation of systemic therapy with other chemotherapeutic agents which may lead to increase in adverse events
• Anaphylactic reactions reported with IV administration of free cytarabine
• Encephalopathy has been reported
• Therapy may cause bone marrow suppression with leukopenia, thrombocytopenia, and anemia; monitor hematopoietic system carefully
• Transient elevations of CSF protein and WBCs reported in patient receiving the therapy
• Caution must be taken in interpreting CSF examinations as cytarabine liposome are similar in size and appearance to WBC

Pregnancy Category:D

Breastfeeding: Safety unknown. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, the use of therapy is not recommended in nursing women.

• CNS: Headache, arachnoiditis, confusion, gait abnormal, convulsion, dizziness, convulsion, memory impairment
• NEURO: Hypoaesthesia, tremor, peripheral neuropathy, neuropathy, peripheral sensory neuropathy, abnormal reflex
• PSYCHIATRIC: Insomnia, agitation, depression, anxiety
• CV: Syncope, hypertension, hypotension, tachycardia
• RESP: Pneumonia, dyspnea, cough
• EENT: Blurred vision, hypoacusis
• GI: Nausea, vomiting, constipation, diarrhea, abdominal pain, dysphagia, hemorrhoids
• HEMA: Decreased in platelet count, anemia, thrombocytopenia, neutropenia, diffuse large B-cell lymphoma
• METABOLIC: Dehydration, decrease in appetite, hyponatraemia, hypokalaemia, hyperglycaemia, anorexia
• MUSC: Back pain, pain in limb, neck pain, arthralgia, neck stiffness, muscle weakness, neck pain
• GU: UTI, incontinence, urinary retention
• DERM: Contusion, pruritus, increase in sweating
• MISC: Weakness, pyrexia, fatigue, lethargy, death, pain, peripheral edema, fall, mucosal inflammation

• Antimetabolite; precise mechanism of action is unknown; acts by inhibition of DNA polymerase; incorporation into DNA and RNA may lead to cytotoxicity
• Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP) (active metabolite)
• Excretion: Urine
• Half-Life: 5.9-82.4 hrs

US Trade Name(s)

• DepoCyt

US Availability

DepoCyt

• INJ: 50 mg/5 mL (5 mL vial)

Canadian Trade Name(s)

• DepoCyt

Canadian Availability

DepoCyt

• INJ: 50 mg/5 mL (5 mL vial)

UK Trade Name(s)

• DepoCyt

UK Availability

DepoCyt

• INJ: 50 mg/5 mL (5 mL vial)

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Antimetabolites