Class: Chemotherapy

Generic Name: Clofarabine (kloe-FARE-eh-been)
Trade Name: Clolar™

For which conditions is this drug approved? Clofarabine is FDA-approved for the treatment of acute lymphoblastic leukemia in pediatric patients (ages 1 to 21 years), that has recurred or stopped responding to at least two prior therapies. 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? Clofarabine belongs to a group of drugs called antimetabolites. Clofarabine 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, clofarabine suppresses the ability of a cell to replicate or repair itself, ultimately causing cellular death.

How is clofarabine typically given (administered)? Clofarabine may be administered intravenously (into a vein). The dose and schedule for the administration of clofarabine is dependent upon many factors, including the particular treatment regimen being utilized, the patient’s height and weight, 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 clofarabine. Typically, blood may be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Physical examinations, scans, or other measures may also be utilized to assess side effects and response to therapy.

In addition, some patients are susceptible to developing a condition called tumor lysis syndrome, in which electrolyte and metabolic disturbances occur. Tumor lysis syndrome can be prevented if managed aggressively at the beginning of treatment. Blood tests will measures levels of electrolyte and metabolic products. Patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort. Capillary leak syndrome or systemic inflammatory response syndrome may also occur. Patients should immediately report signs of this, including difficulty in breathing, rapid breathing, reduced heart rate, and/or dizziness upon standing or sitting from a supine position.

What are the common (occur in 30% or more of patients) side effects of treatment with clofarabine?

• Headache
• Extreme weight loss
• Bloody nose
• Low levels of white blood cells – increases risk of infection
• Low levels of red blood cells – increases risk of anemia
• Low levels of platelets – increases risk of bleeding
• Vomiting
• Nausea
• Diarrhea
• Low white blood cells accompanied by fever
• Increased heart rate
• Abdominal pain
• Fatigue
• Fever
• Shaking
• Skin abnormalities

What are the less common (occur in 10% to 29% of patients) side effects of treatment with clofarabine?

• Constipation
• Bleeding gums
• Sore throat
• Fluid retention
• Pain at injection site
• Weakness, fatigue
• Swelling of mucosa (lining of mouth and alimentary tract)
• Pain
• Enlargement of liver
• Yellowing of skin or eyes
• Infection
• Weight loss
• Decreased appetite
• Muscle pain
• Joint pain
• Limb pain
• Back pain
• Dizziness
• Tremors
• Anxiety
• Depression
• Irritability
• Blood in the urine
• Cough
• Shortness of breath
• Difficulty breathing
• Bruises
• Dry skin
• Hand-foot syndrome: redness, peeling and pain of the skin of hands or soles of feet
• High blood pressure
• Low blood pressure
• Sudden feeling of heat, redness of skin particularly the face

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.
• Keep hands and feet moisturized to help prevent hand-foot syndrome. (Patients should speak with their physician regarding the best products to use for this side effect.)
• Minimize friction, excessive heat and cold to the palms of the hands and soles of the feet to help reduce the incidence and severity of hand-foot syndrome.
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
• 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.)
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.

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?

• Fever
• Chills
• Sore throat
• Cough
• Flu or cold-like symptoms
• Signs of infection (redness, swelling, tenderness, drainage, painful or frequent urination)
• Excessive and persistent fatigue
• Unexplained bleeding (nosebleeds, bruising, blood in urine, black tarry stools, etc.)
• Symptoms that may be indicative of tumor lysis syndrome – nausea, joint pain, lethargy, irregular heartbeat, shortness of breath and/or cloudy urine
• Yellowing of skin or eyes
• Shortness of breath, difficulty breathing
• Signs of capillary leak syndrome or systemic inflammatory response syndrome: difficulty breathing, rapid breathing, dizziness upon standing or sitting, low heart rate
• Abdominal pain
• Loss of balance and coordination, dizziness, extreme lethargy, confusion, headache, mood swings
• Severe or persistent diarrhea
• Severe or persistent nausea or vomiting
• Excessive sleepiness or confusion
• Swelling, redness and pain in one leg or arm and not the other
• Slurred speech
• Numbness, tingling or pain in fingers, toes
• Severe or persistent pain
• Change in heart rate or rhythm
• Swelling of feet or lower legs
• Skin rash or itching
• Severe anxiety
• Yellowing of skin or eyes
• Chest pain
• Extreme weight loss
• Sudden, severe headache

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.

Copyright © 2010 CancerConnect Last updated 07/10.

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Tags: C, Chemotherapy