Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection.
Warning
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Experience of Supervising Clinician
- Conventional cytarabine: Use only under supervision of qualified clinicians experienced in therapy with antineoplastic agents.a b c c j Consider possible benefits vs known risks of cytarabine treatment.a b c j
- Liposomal cytarabine: Use only under supervision of qualified clinicians experienced in intrathecal therapy with antineoplastic agents; adequate diagnostic and treatment facilities must be readily available for management of complications.d
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Induction Therapy with Conventional Cytarabine
- Patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.a b c j
- Risk of serious adverse effects, including myelosuppression with leukopenia, thrombocytopenia, and anemia.a b c j Less serious adverse effects include nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction.a b c j (See Cautions.)
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Chemical Arachnoiditis with Intrathecal Liposomal Cytarabine
- Chemical arachnoiditis, a syndrome manifested principally by nausea, vomiting, headache, and fever, commonly occurs.d If left untreated, may be fatal.d (See Chemical Arachnoiditis Related to Liposomal Cytarabine under Cautions.)
- Administer dexamethasone to ameliorate symptoms and reduce incidence.d (See Liposomal Cytarabine under Dosage and Administration.)
Side effects include:
IV, sub-Q, or IM administration of conventional cytarabine: Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).
Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.
Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.
For Healthcare Professionals
Applies to cytarabine: injectable powder for injection, injectable solution.
Ocular
Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder
Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis
Uncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Blindness[Ref]
Nervous system
Very common (10% or more): Somnolence
Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus
Uncommon (0.1% to 1%): Neurotoxicity, neuritis, dizziness, headache, peripheral neuropathy, paraplegia (with intrathecal administration)
Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Chest pain
Very rare (less than 0.01%): Arrhythmia
Frequency not reported: Pericarditis, cardiomyopathy[Ref]
Hematologic
Very common (10% or more): Bone marrow failure, thrombocytopenia, anemia, megaloblastic anemia, leukopenia, reticulocyte count decreased
Common (1% to 10%): Bleeding (all sites), thrombophlebitis
Frequency not reported: Reticulocytopenia, neutropenia, febrile neutropenia[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Anaphylactic reaction, allergic edema[Ref]
Immunologic
Very common (10% or more): Sepsis, infection
Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)[Ref]
Local
Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis
Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis[Ref]
Musculoskeletal
Very common (10% or more): Cytarabine syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)
Uncommon (0.1% to 1%): Myalgia, joint pain[Ref]
Metabolic
Common (1% to 10%): Anorexia, hyperuricemia[Ref]
Psychiatric
Frequency not reported: Personality change, confusion[Ref]
Genitourinary
Uncommon (0.1% to 1%): Urinary retention
Frequency not reported: Amenorrhea, azoospermia[Ref]
Hepatic
Very common (10% or more): Hepatic function abnormal
Common (1% to 10%): Liver enzymes increased
Uncommon (0.1% to 1%): Jaundice
Frequency not reported: Liver abscess, hyperbilirubinemia, hepatomegaly, Budd-Chiari-syndrome (hepatic venous thrombosis)[Ref]
Respiratory
Very common (10% or more): Pneumonia, acute respiratory distress syndrome, pulmonary edema
Uncommon (0.1% to 1%): Shortness of breath[Ref]
Other
Very common (10% or more): Pyrexia[Ref]
Renal
Uncommon (0.1% to 1%): Renal dysfunction[Ref]
Dermatologic
Very common (10% or more): Alopecia, rash
Common (1% to 10%): Skin ulceration, erythema, bullous dermatitis, vasculitis
Uncommon (0.1% to 1%): Lentigo, palmar-plantar erythrodysesthesia syndrome, urticaria, pruritus, freckling, burning pain of palms and soles
Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis
Frequency not reported: Skin bleeding[Ref]
Gastrointestinal
Very common (10% or more): Stomatitis, mouth ulceration, anal ulcer, anal inflammation, diarrhea, vomiting, nausea, abdominal pain
Common (1% to 10%): Necrotizing colitis
Uncommon (0.1% to 1%): Sore throat, esophagitis, esophageal ulceration, bowel necrosis
Frequency not reported: Pancreatitis, bowel necrosis, GI ulcer, pneumatosis intestinalis, peritonitis, mucosal bleeding[Ref]
