Posted on April 28th, 2009 by
Generic Name: Liposomal cytarabine (sigh-TARE-a-been lip-oh-ZOE-mel), liposomal Ara-C
Trade Name: Depocyt™
For which conditions is this drug approved? Liposomal cytarabine is FDA approved for the treatment of lymphomatous meningitis, which is lymphoma that is present in the meninges (lining of the brain and spinal cord). Liposomal cytarabine has been formulated to produce a sustained release of the chemotherapy agent cytarabine. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Liposomal cytarabine belongs to a group of drugs called antimetabolites. Cytarabine produces its anti-cancer effects by inhibiting the ability of a cell to produce DNA or repair DNA. By inhibiting the production and repair of DNA, cytarabine suppresses the ability of a cell to replicate or repair itself, ultimately causing cellular death.
How is liposomal cytarabine typically given (administered)? Liposomal cytarabine may be delivered into the spinal fluid through intrathecal or intraventricular administration. Intrathecal administration is the direct placement of the drug into the spinal fluid through a spinal tap procedure. Intraventricular administration involves the placement of a small “reservoir”, called an ommaya reservoir, directly under the skin in the scalp. There is a catheter that runs from the ommaya reservoir to the outer part of the brain. Liposomal cytarabine is placed into the ommaya reservoir, where the agent travels through the catheter to the outer part of the brain. Patients typically receive steroids prior to and following liposomal cytarabine to reduce inflammation of the meninges that can be caused by treatment. The route, dose and scheduling in which liposomal cytarabine is administered is dependent upon many factors, including the condition being treated, the particular treatment regimen being utilized, overall health, and the patient’s tolerance of therapy.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with liposomal cytarabine. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, as well as electrolyte and metabolic product levels. Physical examinations, scans, or other measures may also be utilized to assess side effects and response to therapy. Patients will be monitored for inflammation of the meninges, including pain or rigidity of the neck, nausea and vomiting, fever, headache and back pain. If patients experience these symptoms, they should contact their healthcare provider.
What are the common (occur in 30% or more of patients) side effects of treatment with liposomal cytarabine?
• Inflammation of the meninges, which can cause pain or rigidity of the neck, nausea and vomiting, fever, headache and back pain
What are the less common (occur in 10% to 29% of patients) side effects of treatment with liposomal cytarabine?
• Excessive lethargy
• Loss of balance or coordination
• Nausea and vomiting
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Signs of inflammation of the meninges: pain or rigidity of the neck, headache, backache, nausea and vomiting, fever
• Swelling of the feet, ankles or face
• Loss of balance or coordination
• Excessive lethargy or weakness
• Numbness or tingling in the arms, hands, legs or feet
• Muscle stiffness of body movements that are hard to control
• Persistent nausea or vomiting
• Bleeding or bruising
• Signs of infection
• Sore throat, fever, chills, cough, flu or cold-like symptoms
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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