Pacira Pharmaceuticals, Inc.

10450 Science Center Drive
San Diego, CA 92121
(858) 625 2424

5 Sylvan Way
Parsippany, NJ 07054
(973) 254 3560

TAKING CARE OF PATIENTS, TODAY AND TOMORROW

DepoCyt(e)®

DepoCyt(e)® (cytarabine liposome injection) is a sustained-release liposomal formulation of the chemotherapeutic agent cytarabine utilizing Pacira's DepoFoam® technology. DepoCyt(e) is indicated for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma, a cancer of the immune system. The drug was granted accelerated approval by the FDA in 1999 and full approval in 2007.

As opposed to conventional cytarabine, which is administered in the hospital twice weekly by spinal injection, DepoCyt(e) extends the duration of cytarabine efficacy to allow for injection once every two weeks in an outpatient setting.

FULL PRESCRIBING INFORMATION

IMPORTANT SAFETY INFORMATION for DepoCyt(e)

WARNING: DepoCyt(e)® (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic 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 by coadministration of dexamethasone (see WARNINGS). Patients receiving DepoCyt(e)® should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).

To report an adverse event, e-mail drugsafety@pacira.com, dial 1-855-397-2467, Option #1, or fax 1-858-408-3588 or 1-973-201-0649.

For medical inquiries related to DepoCyt, contact Medical Information at medinfo@pacira.com or 1-855-397-2467, Option #2.

DEPOCYT(E) HIGHLIGHT:
LYMPHOMATOUS MENINGITIS

Lymphomatous Meningitis

Lymphomatous meningitis (LM) is cancer that started as primary lymphoma and has spread to the lining of the spinal cord and brain (this lining is the meninges). LM is reported in 5% to 15% of patients with diffuse high-grade non-Hodgkin’s lymphoma.

LM is rarely curable. However, research has shown that treatment that starts soon after the disease is detected can help many patients. In some patients, early treatment can prevent or slow worsening of symptoms caused by growth of cancer in the meninges.

For more information or questions related to the availability of DepoCyt® in the United States or DepoCyte® in Europe, please contact our marketing and distribution partners Sigma-Tau or Mundipharma.