Depocyt

Depocyt is a prescription medication used to treat a certain types of cancers that affects the spinal cord and brain.

Depocyt belongs to a group of drugs called antimetabolites, which work by slowing or stopping the growth of cancer cells.

This medication is available in a liposome injectable form to be given directly into the spine or into the brain by a healthcare professional.

Common side effects of Depocyt include nausea, vomiting, headache, and fever. Depocyt can also cause blurry vision and dizziness. Do not drive or operate heavy machinery until you know how Depocyt affects you.

Depocyt liposome injection is a prescription medication used to treat a specific type of cancers that affects the spinal cord and brain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pacira Pharmaceuticals, Inc.

Common side effects of Depocyt include the following:

• headache
• confusion
• memory loss
• dizziness
• general weakness
• fatigue
• nausea
• vomiting
• constipation
• stomach pain
• muscle aches
• insomnia
• agitation
• anxiety
• depression
• dehydration
• loss of appetite
• cough
• blurry vision
• bleeding

This is not a complete list of Depocyt side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Depocyt. See the “Drug Precautions” section.

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

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

• gentamicin (Gentak, Genoptic)
• digoxin (Lanoxin)
• flucytosine (Ancobon)

This is not a complete list of Depocyt drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Depocyt including the following:

• neurotoxicity. This occurs when the exposure to Depocyt disrupts or even kills neurons, cells that send signals in the brain and other parts of the nervous system. If patients develop neurotoxicity, future doses of Depocyt should be decreased, and Depocyt should be stopped if toxicity persists. Tell your healthcare provider right away if you experience any signs or symptoms of neurotoxicity:
  • limb weakness or numbness
  • memory loss
  • vision loss
  • loss of thinking capacity
  • headache
  • changes in behavior
• lowered blood counts. This is medically known as bone marrow suppression. Your doctor will want to monitor for this, as bone marrow suppression can lead to thrombocytopenia, anemia, and leukopenia.
  • thromobocytopenia. This is a condition in which your blood has a lower than normal number of blood cell fragments called platelets. Tell your healthcare provider right away if you have the following signs and symptoms of thrombocytopenia:
    • mild to serious bleeding
    • purple, brown, and red bruises (purpura)
    • small red or purple dots on your skin (petechiae)
    • prolonged bleeding, even from minor cuts
    • bleeding or oozing from the mouth or nose, especially nosebleeds or bleeding from brushing your teeth
    • abnormal vaginal bleeding (especially heavy menstrual flow)
    • blood in the urine or stool or bleeding from the rectum. Blood in the stool can appear as red blood or as a dark, tarry color. Taking iron supplements also can cause dark, tarry stools.
    • headaches and other neurological symptoms. These problems are very rare, but you should discuss them with your doctor.
  • anemia. This is a condition in which your blood has a lower than normal number of red blood cells. Tell your healthcare provider right away if you have the following signs and symptoms of anemia:
    • shortness of breath
    • dizziness
    • headache
    • coldness in the hands and feet
    • pale skin
    • chest pain
  • leukopenia. This is a condition when there are a low number of white blood cells in your body. These cells help fight infections. You may become more susceptible to infections and even to negative reactions of live vaccines if you are taking Depocyt. Tell your healthcare provider if you are feeling “under the weather” or are running a fever. Also, let your healthcare provider know if you are scheduled to receive a vaccination, as live vaccinations can make you sick.
  • Benzyl alcohol is contained in the non-liposome formulation. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

Do not take cytarabine if you:

• are allergic to any of its ingredients
• have a meningeal infection

DO NOT USE CYTARABINE INJECTION (which contains benzyl alcohol) INTRATHECALLY (into the brain or spinal cord). Only Depocyt liposome formulation may be given intrathecally.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Depocyt, there are no specific foods that you must exclude from your diet when 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Depocyt falls into category D. It has been shown that use of Depocyt in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Avoiding pregnancy while taking Depocyt is recommended in women of childbearing potential.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is known that Depocyt can cross into human milk. Because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Depocyt.

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.

Since Depocyt is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

LIPISOME INJECTION FORMULATION:

This medication 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. Patients receiving this medication should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis.