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chlorambucil

Generic Name: chlorambucil (klor AM bue sil)
Brand Name: Leukeran

What is chlorambucil?

Chlorambucil is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Chlorambucil is used to treat several types of cancer, including Hodgkin's disease and certain types of leukemia or lymphoma.

Chlorambucil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about chlorambucil?

Chlorambucil is a cancer medication used to treat several types of cancer.

Chlorambucil can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

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What should I discuss with my healthcare provider before taking chlorambucil?

You should not use this medication if you are allergic to chlorambucil, or if you have received this medication in the past without successful treatment of your condition.

To make sure you chlorambucil is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • a history of seizures;

  • a history of head injury or brain tumor; or

  • if you have received radiation or chemotherapy within the past 4 weeks.

Taking chlorambucil may increase your risk of developing other types of cancer. Talk to your doctor about your specific risk.

FDA pregnancy category D. Do not use chlorambucil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether chlorambucil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take chlorambucil?

You must remain under the care of a doctor while you are using chlorambucil.

Chlorambucil is usually taken for 3 to 6 weeks. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Chlorambucil can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Store chlorambucil tablets in the refrigerator, do not freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking chlorambucil?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Do not receive a "live" vaccine while using chlorambucil. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Chlorambucil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking chlorambucil and call your doctor at once if you have:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat, ongoing cough;

  • pale skin, easy bruising, unusual bleeding, blood in your urine or stools;

  • feeling weak or tired, loss of appetite, rapid weight loss;

  • nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • an unusual mass or lump;

  • chest discomfort, feeling short of breath on exertion, dry cough or hack;

  • severe vomiting or diarrhea;

  • seizure (convulsions); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • mild nausea or diarrhea;

  • tremors or shaking; or

  • numbness, burning pain, or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Chlorambucil Dosing Information

Usual Adult Dose for Hodgkin's Disease:

For initiation of therapy or for short courses of treatment:
Usual Dosage: 0.1 to 0.2 mg/kg orally daily for 3 to 6 weeks as required. (This usually amounts to 4 to 10 mg per day for the average patient.) The entire daily dose may be given at one time. The dosage must be carefully adjusted according to the response of the patient and must be reduced as soon as there is an abrupt fall in the white blood cell count. Patients with Hodgkin's disease usually require 0.2 mg/kg daily. Patients with other lymphomas or chronic lymphocytic leukemia usually require only 0.1 mg/kg daily. When lymphocytic infiltration of the bone marrow is present, or when the bone marrow is hypoplastic, the daily dose should not exceed 0.1 mg/kg (about 6 mg for the average patient).

Alternatively the initial dosage of chlorambucil for the treatment of Hodgkin's disease is 10 mg orally once a day for seven days out of twenty one. This regimen also includes vinblastine, procarbazine, prednisolone, etoposide, vincristine, and doxorubicin.

Alternate schedules for the treatment of chronic lymphocytic leukemia employing intermittent, biweekly, or once-monthly pulse doses of chlorambucil have been reported. Intermittent schedules of chlorambucil begin with an initial single dose of 0.4 mg/kg. Doses are generally increased by 0.1 mg/kg until control of lymphocytosis or toxicity is observed. Subsequent doses are modified to produce mild hematologic toxicity. It is felt that the response rate of chronic lymphocytic leukemia to the biweekly or once-monthly schedule of chlorambucil administration is similar or better to that previously reported with daily administration and that hematologic toxicity was less than or equal to that encountered in studies using daily chlorambucil.

Radiation and cytotoxic drugs render the bone marrow more vulnerable to damage, and chlorambucil should be used with particular caution within 4 weeks of a full course of radiation therapy or chemotherapy. However, small doses of palliative radiation over isolated foci remote from the bone marrow will not usually depress the neutrophil and platelet count. In these cases chlorambucil may be given in the customary dosage.

It is presently felt that short courses of treatment are safer than continuous maintenance therapy, although both methods have been effective. It must be recognized that continuous therapy may give the appearance of "maintenance" in patients who are actually in remission and have no immediate need for further drug. If maintenance dosage is used, it should not exceed 0.1 mg/kg daily and may well be as low as 0.03 mg/kg daily.

Typical maintenance dose is 2 mg to 4 mg daily, or less, depending on the status of the blood counts. It may, therefore, be desirable to withdraw the drug after maximal control has been achieved, since intermittent therapy reinstituted at time of relapse may be as effective as continuous treatment.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

For initiation of therapy or for short courses of treatment:
Usual Dosage: 0.1 to 0.2 mg/kg orally daily for 3 to 6 weeks as required. (This usually amounts to 4 to 10 mg per day for the average patient.) The entire daily dose may be given at one time. The dosage must be carefully adjusted according to the response of the patient and must be reduced as soon as there is an abrupt fall in the white blood cell count. Patients with Hodgkin's disease usually require 0.2 mg/kg daily. Patients with other lymphomas or chronic lymphocytic leukemia usually require only 0.1 mg/kg daily. When lymphocytic infiltration of the bone marrow is present, or when the bone marrow is hypoplastic, the daily dose should not exceed 0.1 mg/kg (about 6 mg for the average patient).

Alternatively the initial dosage of chlorambucil for the treatment of Hodgkin's disease is 10 mg orally once a day for seven days out of twenty one. This regimen also includes vinblastine, procarbazine, prednisolone, etoposide, vincristine, and doxorubicin.

Alternate schedules for the treatment of chronic lymphocytic leukemia employing intermittent, biweekly, or once-monthly pulse doses of chlorambucil have been reported. Intermittent schedules of chlorambucil begin with an initial single dose of 0.4 mg/kg. Doses are generally increased by 0.1 mg/kg until control of lymphocytosis or toxicity is observed. Subsequent doses are modified to produce mild hematologic toxicity. It is felt that the response rate of chronic lymphocytic leukemia to the biweekly or once-monthly schedule of chlorambucil administration is similar or better to that previously reported with daily administration and that hematologic toxicity was less than or equal to that encountered in studies using daily chlorambucil.

Radiation and cytotoxic drugs render the bone marrow more vulnerable to damage, and chlorambucil should be used with particular caution within 4 weeks of a full course of radiation therapy or chemotherapy. However, small doses of palliative radiation over isolated foci remote from the bone marrow will not usually depress the neutrophil and platelet count. In these cases chlorambucil may be given in the customary dosage.

It is presently felt that short courses of treatment are safer than continuous maintenance therapy, although both methods have been effective. It must be recognized that continuous therapy may give the appearance of "maintenance" in patients who are actually in remission and have no immediate need for further drug. If maintenance dosage is used, it should not exceed 0.1 mg/kg daily and may well be as low as 0.03 mg/kg daily.

Typical maintenance dose is 2 mg to 4 mg daily, or less, depending on the status of the blood counts. It may, therefore, be desirable to withdraw the drug after maximal control has been achieved, since intermittent therapy reinstituted at time of relapse may be as effective as continuous treatment.

Usual Adult Dose for Lymphoma:

For initiation of therapy or for short courses of treatment:
Usual Dosage: 0.1 to 0.2 mg/kg orally daily for 3 to 6 weeks as required. (This usually amounts to 4 to 10 mg per day for the average patient.) The entire daily dose may be given at one time. The dosage must be carefully adjusted according to the response of the patient and must be reduced as soon as there is an abrupt fall in the white blood cell count. Patients with Hodgkin's disease usually require 0.2 mg/kg daily. Patients with other lymphomas or chronic lymphocytic leukemia usually require only 0.1 mg/kg daily. When lymphocytic infiltration of the bone marrow is present, or when the bone marrow is hypoplastic, the daily dose should not exceed 0.1 mg/kg (about 6 mg for the average patient).

Alternatively the initial dosage of chlorambucil for the treatment of Hodgkin's disease is 10 mg orally once a day for seven days out of twenty one. This regimen also includes vinblastine, procarbazine, prednisolone, etoposide, vincristine, and doxorubicin.

Alternate schedules for the treatment of chronic lymphocytic leukemia employing intermittent, biweekly, or once-monthly pulse doses of chlorambucil have been reported. Intermittent schedules of chlorambucil begin with an initial single dose of 0.4 mg/kg. Doses are generally increased by 0.1 mg/kg until control of lymphocytosis or toxicity is observed. Subsequent doses are modified to produce mild hematologic toxicity. It is felt that the response rate of chronic lymphocytic leukemia to the biweekly or once-monthly schedule of chlorambucil administration is similar or better to that previously reported with daily administration and that hematologic toxicity was less than or equal to that encountered in studies using daily chlorambucil.

Radiation and cytotoxic drugs render the bone marrow more vulnerable to damage, and chlorambucil should be used with particular caution within 4 weeks of a full course of radiation therapy or chemotherapy. However, small doses of palliative radiation over isolated foci remote from the bone marrow will not usually depress the neutrophil and platelet count. In these cases chlorambucil may be given in the customary dosage.

It is presently felt that short courses of treatment are safer than continuous maintenance therapy, although both methods have been effective. It must be recognized that continuous therapy may give the appearance of "maintenance" in patients who are actually in remission and have no immediate need for further drug. If maintenance dosage is used, it should not exceed 0.1 mg/kg daily and may well be as low as 0.03 mg/kg daily.

Typical maintenance dose is 2 mg to 4 mg daily, or less, depending on the status of the blood counts. It may, therefore, be desirable to withdraw the drug after maximal control has been achieved, since intermittent therapy reinstituted at time of relapse may be as effective as continuous treatment.

Usual Pediatric Dose for Malignant Disease:

Remission Induction: 0.1 to 0.2 mg/kg/day or 4.5 mg/m2/day once daily for 3 to 6 weeks
Maintenance Therapy: 0.03 to 0.1 mg/kg/day

Nephrotic Syndrome: 0.1 to 0.2 mg/kg/day every day for 5 to 12 weeks with low dose prednisone.

Chronic Lymphocytic Leukemia:
Initial Dose: 0.4 mg/kg every 2 weeks. Increase dose by 0.1 mg/kg every 2 weeks until a response occurs and/or myelosuppression occurs.
Alternate Initial Dose: 0.4 mg/kg every 4 weeks. Increase dose by 0.2 mg/kg every 2 weeks until a response occurs and/or myelosuppression occurs.

Non-Hodgkin's Lymphoma: 0.1 mg/kg/day

Hodgkin's Lymphoma: 0.2 mg/kg/day

What other drugs will affect chlorambucil?

Other drugs may interact with chlorambucil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about chlorambucil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2013-07-01, 12:41:40 PM.

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