Generic Name: Chlorambucil (klor-AM-byoo-sil)
Trade Name: Leukeran®
For which conditions is this drug approved? Chlorambucil is FDA approved for the treatment of chronic lymphocytic leukemia and malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. Chlorambucil is not intended to produce a cure in any of these cancers but to produce a clinical benefit. 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? Chlorambucil belongs to a group of drugs referred to as alkylating agents. Chlorambucil produces anti-cancer effects by causing a chemical reaction that damages the DNA in a cell. The DNA damage caused by chlorambucil results in cellular death.
How is chlorambucil typically given (administered)? Chlorambucil is a coated tablet given by mouth. The precise dose and scheduling of chlorambucil depends on the condition being treated, the particular treatment regimen being used, the overall health of the patient and the tolerance of therapy by the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with chlorambucil. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys and liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Patients will also be assessed for skin reactions, such as rash, as this can be indicative of progression to more serious side effects. Patients who experience any skin reactions should contact their healthcare provider immediately. Lung function may also be assessed, as damage to lungs may occur, although this is uncommon. Patients who experience difficulty breathing or shortness of breath should contact their healthcare provider.
What are the common (occur in 30% or more of patients) side effects of treatment with chlorambucil?
• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia and blood transfusions
• Low platelet levels – increases risk of bleeding
What are the less common (occur in 10% to 29% of patients) side effects of treatment with chlorambucil?
• Nausea and vomiting
• Skin reactions, such as a rash, that can lead to more serious side effects if treatment is not discontinued
• Abnormalities in liver function levels as determined by blood tests
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 are the possible late side effects of treatment with chlorambucil? With the use of chlorambucil, there is risk of developing side effects months or years after treatment has been completed. In some instances, a secondary malignancy may occur as a result of receiving chlorambucil. A secondary malignancy is a new cancer that is unrelated the cancer that was initially treated. Secondary malignancies occur as a result of previous treatment with radiation or chemotherapy. Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment. Sterility may also occur as a result of treatment with chlorambucil. Pulmonary (lung) damage is also a uncommon occurrence that may occur late after completing treatment with chlorambucil. Patients should discuss these possible delayed side effects with their physician.
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.)
• 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.
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 if they have had any seizures as they may be more prone to seizures.
• 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.
• If an oral dose is missed, do not double up on doses. Patients should contact their physician in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.
When should patients notify their physician?
• Rash, or any skin abnormalities
• Flu or cold-like symptoms
• Signs of infection – redness, swelling, pus, tenderness
• Difficulty breathing
• Persistant cough
• Unusual lumps or masses
• Yellowing of the skin or eyes
• Unexplained bleedings (nosebleeds, blood in urine, black tarry stools, bruising, etc.)
• Extreme, prolonged fatigue
• Muscle cramping or weakness
• Persistent nausea and vomiting
• Numbness or tingling of fingers or toes
• Swelling of ankles, feet or face
• Menstrual irregularities
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.
Important Limitations of Use
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