Tarabine PFS

Cytarabine is a prescription medication used to treat a certain types of cancers that affects the spinal cord and brain. A different injectable form is used to treat different types of leukemia, or blood cancer that begins in the bone marrow. Cytarabine 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.

This medication is available in an injectable form to be given directly into the vein (IV) or under the skin (subcutaneously) by a healthcare professional.

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

Cytarabine liposome injection is a prescription medication used to treat a specific type of cancers that affects the spinal cord and brain. A different injectable form is used to treat different types of leukemia, or blood cancer that begins in the bone marrow.

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

Common side effects of cytarabine 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 cytarabine side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cytarabine. 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 cytarabine drug interactions. Ask your doctor or pharmacist for more information.

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

• neurotoxicity. This occurs when the exposure to cytarabine 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 cytarabine should be decreased, and cytarabine 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 cytarabine. 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 the 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 cytarabine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking cytarabine, 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.

Cytarabine falls into category D. It has been shown that use of cytarabine 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 cytarabine is recommended in women of childbearing potential.

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

It is known that cytarabine 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 cytarabine.

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

Patients receiving cytarabine 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).

Cytarabine is administered by a healthcare provider in a medical setting. The cytarabine 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.

Cytarabine dosing is as follows:

• For induction therapy of acute non-lymphocytic leukemia, the usual cytarabine dose in combination with other anticancer drugs is 100 mg/m²/day by continuous IV (into the vein) infusion (Days 1 to 7) or 100 mg/m² IV every 12 hours (Days 1 to 7).
• For acute leukemia: doses range from 5 mg/m² to 75 mg/m² of body surface area.
  • The frequency of administration may vary from once a day for 4 days to once every 4 days.
  • The most frequently used dose was 30 mg/m² every 4 days, followed by one additional treatment.

If you take too much cytarabine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If cytarabine 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.

• Protect from freezing and avoid aggressive agitation. Protect from light.
• Available as individual carton containing one ready to use vial.
• Keep this and all medicines out of the reach of children.

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.

INJECTABLE FORMULATION:

Only physicians experienced in cancer chemotherapy should use cytarabine Injection.

For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia.

Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration and hepatic dysfunction.

The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgment or beginning treatment, the physician should be familiar with the following text.