DepoCyt

Cytarabine liposomal is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Cytarabine liposomal is used to treat lymphoma associated with meningitis.

Cytarabine liposomal may also be used for purposes not listed in this medication guide.

Cytarabine liposomal is a cancer medication that interferes with the growth and spread of cancer cells in the body.

You should not receive this medication if you have an active meningitis infection.

Call your doctor at once if you have nausea and vomiting with headache and fever. These may be early signs of central nervous system damage.

You should not receive this medication if you are allergic to cytarabine liposomal or if you have an active meningitis infection.

Before you use cytarabine liposomal, tell your doctor about all your medical conditions.

Do not use cytarabine liposomal if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether cytarabine liposomal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving this medication.

Before taking Depocyt, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any of its ingredients
• have a meningeal infection
• have blood problems
• are scheduled to receive a vaccine
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Depocyt is administered by a healthcare provider in a medical setting.

Patients receiving Depocyt liposome formulation should be treated also with dexamethasone to reduce the symptoms of chemical arachnoiditis (inflammation of the covering of the spinal cord and brain).

Depocyt is administered by a healthcare provider in a medical setting. The Depocyt dose your doctor recommends will be based on the following:

• the condition being treated
• how you respond to this medication

Depocyt (cytarabine) dosing is as follows:

• For the treatment of lymphomatous meningitis
  • Induction therapy: Depocyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 2 doses (weeks 1 and 3).
  • Consolidation therapy: Depocyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 3 doses (weeks 5, 7 and 9) followed by 1 additional dose at week 13.
  • Maintenance therapy: Depocyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 28 days for 4 doses (weeks 17, 21, 25 and 29).
  • If drug related neurotoxicity develops, the dose should be reduced to 25 mg. If it persists, treatment with Depocyt should be discontinued.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Other drugs may interact with cytarabine liposomal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In the U.S.

• Depocyt

Available Dosage Forms:

• Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Back pain
• fever
• headache
• nausea
• neck pain or rigidity
• sleepiness
• vomiting
• weakness

• Black, tarry stools
• blood in urine or stools
• chills
• cough or hoarseness
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• sore throat
• swelling of fingers, hands, arms, lower legs, or feet
• unusual bleeding or bruising

• Fast or irregular breathing
• puffiness or swelling around the face
• shortness of breath
• sudden, severe decrease in blood pressure
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• urinary incontinence

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No overdosages with DepoCyt® (cytarabine liposome injection) have been reported. An overdose with DepoCyt may be associated with severe chemical arachnoiditis including encephalopathy. In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered. There is no antidote for overdose of intrathecal DepoCyt or unencapsulated cytarabine released from DepoCyt. Exchange of CSF with isotonic saline has been carried out in a case of intrathecal overdose of free cytarabine, and such a procedure may be considered in the case of DepoCyt overdose. Management of overdose should be directed at maintaining vital functions.

DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, for intrathecal administration. The chemical name of cytarabine is 4-amino-1 -β-D-arabinofuranosyl-2(1H)-pyrimidinone, and is also known as cytosine arabinoside . It has a molecular formula of C9H13N3O5, and a molecular weight 243.22 g/mol. Cytarabine has the following structural formula:

DepoCyt is available as a single-dose vial containing 50 mg/5 mL (10 mg/mL) of cytarabine. DepoCyt is formulated as a sterile, non-pyrogenic, white to off-white suspension of cytarabine liposomes in 0.9% w/v sodium chloride in water for injection. Each mL contains 10 mg cytarabine, 4.4 mg cholesterol, 1.2 mg triolein, 5.7 mg dioleoylphosphatidylcholine (DOPC), and 1.0 mg dipalmitoylphosphatidylglycerol (DPPG). DepoCyt is preservative-free. The pH of the product falls within the range from 5.5 to 8.5.

Liposome drug products may behave differently from nonliposome drug products. DepoCyt (cytarabine liposome injection) is not equivalent to, and cannot be substituted for, other drug products containing cytarabine.

DepoCyt® (cytarabine liposome injection) was studied in 2 controlled clinical studies that enrolled patients with neoplastic meningitis.

Study 1 – Solid Tumors, Lymphoma, or Leukemia

The first study, which was a randomized, multi-center, multi-arm study involving a total of 99 treated patients, compared 50 mg of DepoCyt administered every 2 weeks to standard intrathecal chemotherapy administered twice a week to patients with solid tumors, lymphoma, or leukemia. For patients with lymphoma, standard therapy consisted of 50 mg of unencapsulated cytarabine given twice a week. Thirty-three lymphoma patients (17 DepoCyt, 16 cytarabine) were treated. Patients went off study if they had not achieved a complete response defined as clearing of the CSF from all previously positive sites in the absence of progression of neurological symptoms, after 4 weeks of treatment with study drug.

In the first study, complete response was prospectively defined as (1) conversion, confirmed by a blinded central pathologist, from a positive examination of the CSF for malignant cells to a negative examination on two separate occasions (at least 3 days apart, on day 29 and later) at all initially positive sites, together with (2) an absence of neurological progression during the treatment period.

The complete response rates in the first study of lymphoma are shown in Table 3. Although there was a plan for central pathology review of the data, in 4 of the 7 responding patients on the DepoCyt arm this was not accomplished and these cases were considered to have had a complete response based on the reading of an unblinded pathologist. The median overall survival of all treated patients was 99.5 days in the DepoCyt group and 63 days in the cytarabine group. In both groups the majority of patients died from progressive systemic disease, not neoplastic meningitis.

Study 2 – Lymphoma

The second study was a randomized, multi-center, multi-arm study involving a total of 124 treated patients with either solid tumors or lymphomas. In this study, 24 patients with lymphoma were randomized and treated with DepoCyt or cytarabine. Patients received 6 two-week induction cycles of DepoCyt 50 mg every 2 weeks or cytarabine 50 mg twice weekly. Patients then received four maintenance cycles of DepoCyt 50 mg every 4 weeks, or cytarabine 50 mg weekly for 4 weeks. In both studies, patients received concurrent treatment with dexamethasone to minimize symptoms associated with chemical arachnoiditis [see Warnings and Precautions (5) and Dosage and Administration (2)]. In this study, cytological response was assessed in a blinded fashion utilizing a similar definition as in the first study. The results in patients with lymphomatous meningitis are shown in Table 3.