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cytarabine injection, lipid complex
Pharmacologic class: Antimetabolite, pyrimidine analog
Therapeutic class: Antineoplastic
Pregnancy risk category D
FDA Box Warning
• Drug should be given only by physicians experienced in cancer chemotherapy. For induction therapy, patients should be in facility with adequate resources to monitor drug tolerance and treat drug toxicity. Main toxic effect is bone marrow suppression with leukopenia, thrombocytopenia, and anemia. Less serious toxicities include nausea, vomiting, diarrhea, abdominal pain, oral ulcers, and hepatic dysfunction.
• Prescriber must weigh possible benefit against known toxic effects and should be familiar with complete package insert information.
• Give DepoCyt (liposomal injection) only under supervision of physician experienced with intrathecal cancer chemotherapy, in facility with adequate diagnostic and treatment resources. In all clinical studies, chemical arachnoiditis (manifested mainly by nausea, vomiting, headache, and fever) was common adverse event; unless treated, it may be fatal. Patients receiving DepoCyt should receive dexamethasone concurrently to mitigate arachnoiditis symptoms.
Unclear. Cytotoxic effect may stem from inhibition of DNA polymerase by drug's active metabolite.
Injection (conventional form): 20 mg Liposomal injection for intrathecal use (sustained-release): 50 mg/5-ml vial Powder for injection (conventional form): 100 mg, 500 mg, 1g, 2 g
Indications and dosages
➣ To induce remission of acute nonlymphocytic leukemia
Adults: Injection (conventional form)-100 mg/m2/day by continuous I.V. infusion on days 1 through 7, or 100 mg/m2 I.V. q 12 hours on days 1 through 7, given with other antineoplastics
➣ Meningeal leukemia
Adults: Injection (conventional form)-5 to 75 mg/m2/day intrathecally for 4 days, or once q 4 days. Most common dosage is 30 mg/m2 q 4 days until cerebrospinal fluid is normal.
➣ Lymphomatous meningitis
Adults: Liposomal injection-50 mg intrathecally q 14 days for two doses (at weeks 1 and 3); then q 14 days for three doses (at weeks 5, 7, and 9), with one additional dose at week 13; then q 28 days for four doses
• Hypersensitivity to drug
• Active meningeal infection (liposomal form)
Use cautiously in:
• renal or hepatic disease, active infection, decreased bone marrow reserve, other chronic illnesses
• pregnant or breastfeeding patients.
• Follow facility procedures for safe handling, administration, and disposal of chemotherapeutic drugs.
• For I.V. injection, reconstitute each 100 mg with 5 ml of diluent (if necessary), and give each 100-mg dose over 1 to 3 minutes. For I.V. infusion, dilute further with 50 to 100 ml of dextrose 5% in water or normal saline solution, and infuse over 30 minutes to 24 hours (depending on dosage and concentration).
• Be aware that conventional and liposomal forms can be administered intrathecally.
☞ Don't use intrathecal route for formulations containing benzyl alcohol.
• When giving conventional form intrathecally, reconstitute with autologous spinal fluid or preservative-free normal saline solution for injection. Use immediately.
• Patients receiving intrathecal cytarabine should be treated concurrently with dexamethasone to mitigate symptoms of chemical arachnoiditis.
CNS: malaise, dizziness, headache, neuritis, neurotoxicity, chemical arachnoiditis
CV: chest pain, thrombophlebitis
EENT: conjunctivitis, visual disturbances including permanent blindness (with liposomal form)
GI: nausea, vomiting, diarrhea, abdominal pain, anal ulcers, esophagitis, esophageal ulcers, oral ulcers (in 5 to 10 days), anorexia, bowel necrosis
GU: urinary retention, renal dysfunction
Hematologic: anemia, megaloblastosis, reticulocytopenia, leukopenia, thrombocytopenia
Hepatic: hepatic dysfunction
Musculoskeletal: muscle ache, bone pain
Respiratory: pneumonia, shortness of breath
Skin: rash, pruritus, freckling, skin ulcers, urticaria, alopecia
Other: flulike symptoms, edema, infection, fever, cellulitis at injection site, anaphylaxis, infection (mild to fatal)
Drug-drug. Digoxin: decreased digoxin blood level
Fluorocytosine: decreased fluorocytosine blood level
Gentamicin: decreased gentamicin effects
Drug-diagnostic tests. Hemoglobin, platelets, red blood cells, reticulocytes, white blood cells: decreased values
Megaloblasts, uric acid: increased levels
• Observe for signs and symptoms of cytarabine syndrome (malaise, fever, muscle ache, bone pain, occasional chest pain, maculopapular rash, and conjunctivitis).
☞ When giving liposomal form, assess for signs and symptoms of chemical arachnoiditis, such as neck rigidity and pain, nausea, vomiting, headache, fever, and back pain.
• Monitor liver function test results, CBC with differential, platelet count, blood urea nitrogen, and serum creatinine and uric acid levels.
☞ Observe closely for signs and symptoms of infection, which could become severe and fatal.
☞ Tell patient to contact prescriber immediately if he develops signs or symptoms of infection, cytarabine syndrome (malaise, fever, muscle ache, bone pain, chest pain, rash, eye infection), or chemical arachnoiditis (neck rigidity or pain, nausea, vomiting, headache, fever, or back pain).
☞ Tell patient that drug makes him more susceptible to infection. Advise him to avoid crowds and exposure to illness.
• Advise patient to increase fluid intake, to promote uric acid excretion.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.