Cytarabine

What is Cytarabine?

• Cytarabine Injection, an antineoplastic used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma.

Cytarabine

Cytarabine active

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Cytarabine ball-and-stick

What are the uses of this medicine?

Cytarabine is used with other drugs to treat:

• Acute non-lymphocytic leukemia in adults and children.

Cytarabine is also approved to prevent and treat:

• Meningeal leukemia (leukemia that has spread to the meninges). It is given as intrathecal therapy.

Cytarabine may also be used to treat:

• Acute lymphoblastic leukemia (ALL).
• Chronic myelogenous leukemia (CML) in blastic phase.

How does this medicine work?

• Cytarabine is a pyrimidine analog and is also known as arabinosylcytosine (ARA-C).
• It is converted into the triphosphate form within the cell and competes with cytidine to incorporate itself in the DNA.
• The sugar moiety of cytarabine hinders the rotation of the molecule within the DNA.
• The DNA replication ceases, specifically during the S phase of the cell cycle, making it a specific drug for rapidly dividing cells, such as those seen in cancer.
• DNA replication and repair also halts due to the inhibition of DNA polymerase by cytarabine.
• This drug must act for a time equivalent to one cell cycle to effectively inhibit the replication of tumor cells.
• Hence the bolus dose of cytarabine is given every 8 to 12 hours to maintain optimum intracellular levels.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are hypersensitive to the drug

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• digoxin (Lanoxin), flucytosine (Ancobon), or gentamicin.
• Other medications may also interact with cytarabine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

Is this medicine FDA approved?

• Cytarabine was patented in 1960 and approved for medical use in 1969.

How should this medicine be used?

Recommended dosage: Acute non-lymphocytic leukemia:

• In the induction therapy of acute non-lymphocytic leukemia, the usual cytarabine dose in combination with other anti-cancer drugs is 100 mg/m2/day by continuous intravenous infusion (Days 1–7) or 100 mg/m2 intravenous every 12 hours (Days 1–7).

Meningeal leukemia:

• Cytarabine injection has been used intrathecally in acute leukemia in doses ranging from 5 mg/m2 to 75 mg/m2 of body surface area.
• The frequency of administration varied from once a day for 4 days to once every 4 days.

Acute lymphoblastic leukemia (ALL):

• Administer 3,000 mg/sq.meter of cytarabine over 3 hours by intravenous infusion daily for five days in combination with idarubicin for three days.

Administration:

• Cytarabine comes as a powder to mixed with liquid to be injected intravenously (into a vein), subcutaneously (under the skin), or intrathecally (into the fluid-filled space of the spinal canal) by a doctor or nurse in a medical facility.
• Your doctor will tell you how often you will receive cytarabine.
• The schedule depends on the condition you have and on how your body responds to the medication.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Solution, Injection: 10 mg/ml, 20 mg/mL (25 mL), 100 mg/ml
• Intrathecal injection, liposomal: 50 mg/5ml

This medicine is available in fallowing brand namesː

• Cytosar-U

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• stomach pain
• loss of appetite
• sores in the mouth and throat
• hair loss
• muscle or joint pain
• tiredness
• sore or red eyes

Cytarabine may cause some serious side effects:

• ongoing pain that begins in the stomach area but may spread to the back
• redness, pain, swelling, or burning at the site where the injection was given
• pale skin
• fainting
• dizziness
• fast or irregular heartbeat
• rash
• hives
• itching
• difficulty breathing or swallowing
• chest pain
• yellowing of the skin or eyes
• dark-colored urine or decreased urination
• shortness of breath
• sudden change or loss of vision
• seizures
• confusion
• numbness, burning, or tingling in the hands, arms, feet, or legs

What special precautions should I follow?

• The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
• Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine injection) has been reported following some experimental dose schedules for cytarabine injection.
• Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation.
• Complete alopecia is more commonly seen with experimental high dose therapy than with standard treatment programs using cytarabine injection.
• Patients receiving Cytarabine Injection must be monitored closely. Frequent platelet and leucocyte counts and bone marrow examinations are mandatory.
• Like other cytotoxic drugs, Cytarabine Injection may induce hyperuricemia secondary to rapid lysis of neoplastic cells.
• Acute pancreatitis has been reported to occur in a patient receiving Cytarabine Injection by continuous infusion and in patients being treated with Cytarabine Injection who have had prior treatment with L-asparaginase.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Cytarabine Injection can cause fetal harm when administered to a pregnant woman.
• Women of childbearing potential should be advised to avoid becoming pregnant.

Can this medicine be used in children?

• Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• cytarabine

Inactive ingredients include:

• sodium chloride
• water
• hydrochloric acid
• sodium hydroxide

Who manufactures and distributes this medicine?

• Distributed by Hospira, Inc., Lake Forest, IL USA

What should I know about storage and disposal of this medication?

• Protect from light.
• Retain in carton until time of use.
• Store at 20°C to 25°C (68°F to 77°F).

• Dailymed label info on Cytarabine
• FDA Cytarabine

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