- DepoCyt should be administered only under the supervision
of a qualified physician experienced in the use of intrathecal
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. The incidence
and severity of chemical arachnoiditis can be reduced
(see WARNINGS). Patients
receiving DepoCyt should be treated concurrently with
to mitigate the symptoms of chemical
- (see DOSAGE AND ADMINISTRATION).
DepoCyt is a sterile,
of the antimetabolite
cytarabine, encapsulated into multivesicular lipid-based particles.
Chemically, cytarabine is 4-amino-1-b-D-arabinofuranosyl-2(1H)-pyrimidinone,
also known as cytosine
molecular weight 243.22).
DepoCyt is available in 5 mL, ready-to-use, single-use vials containing
50 mg of cytarabine. DepoCyt
is formulated as a sterile,
non-pyrogenic, white to off-white suspension
of cytarabine in
Sodium Chloride 0.9% w/v in Water for Injection. DepoCyt is preservative-free.
Cytarabine, the active ingredient, is present
at a concentration
of 10 mg/mL, and is encapsulated in the particles. Inactive ingredients
at their respective approximate concentrations are cholesterol
4.1 mg/mL, triolein
1.2 mg/mL, dioleoylphosphatidylcholine (DOPC) 5.7 mg/mL, and dipalmitoylphosphatidylglycerol
(DPPG) 1.0 mg/mL. The pH
of the product falls
within the range from
5.5 to 8.5.