Equipped Facility/Experience Physician
- This drug should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapy agents.
- Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
- In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache, and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal.
- Severity and incidence may be reduced with concurrent administration of dexamethasone.
- Patients receiving this drug should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patients should be started on dexamethasone 4 mg twice daily either orally or intravenously for five days beginning on the day of cytarabine liposomal injection.
Patient Counseling Information
Updated January 2018