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Chlorambucil (Oral route)

Pronunciation:

klor-AM-bue-sil

Brand Names:

  • Leukeran

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Chlorambucil can severely suppress bone marrow function. It is a carcinogen in humans, and is probably mutagenic and teratogenic. Chlorambucil produces human infertility .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrogen Mustard

Uses of This Medicine:

Chlorambucil belongs to the group of medicines called alkylating agents. It is used to treat different types of cancer of the blood and lymph system, such as chronic lymphatic leukemia, Hodgkin's disease, and other types of lymphoma.

Chlorambucil interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by this medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may occur after treatment with chlorambucil has been stopped.

Before you begin treatment with chlorambucil, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, chlorambucil is used in certain patients with the following medical conditions:

  • Cancer of the lymph system that affects the skin.
  • Cancer of the ovaries.
  • Hairy cell leukemia (a cancer of the blood and bone marrow).
  • Histiocytosis X (a certain type of cancer found primarily in children).
  • Nephrotic syndrome (a kidney disease).
  • Tumors in the uterus (womb).
  • Waldenström's macroglobulinemia (a certain type of cancer of the blood).

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of chlorambucil in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of chlorambucil in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this chlorambucil.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acrivastine
  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Bupropion
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow depression or
  • Head injury or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Gout or
  • Kidney stones, history of—Chlorambucil may increase levels of uric acid in the body, which can cause gout or kidney stones.
  • Infection—May decrease your body's ability to fight infection.
  • Kidney disease (e.g., nephrotic syndrome)—Use with caution. May increase risk for seizures.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Chlorambucil is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.

While you are using chlorambucil, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine sometimes causes nausea and vomiting. However, it is very important that you continue to use the medicine, even if you begin to feel ill. Do not stop using this medicine without first checking with your doctor. Ask your doctor for ways to lessen these effects.

If you vomit shortly after taking a dose of chlorambucil, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For chronic lymphatic leukemia and other types of lymphoma:
      • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.1 milligram (mg) per kilogram (kg) of body weight per day, taken as a single dose, for 3 to 6 weeks.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of Hodgkin's disease:
      • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.2 milligram (mg) per kilogram (kg) of body weight per day, taken as a single dose, for 3 to 6 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

While you are being treated with chlorambucil, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Chlorambucil may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Chlorambucil can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have the following symptoms while taking this medicine: skin rash, fever, cough that won't go away, irregular monthly period, nausea or vomiting, seizures, unusual lumps, or yellow eyes or skin.

Make sure your doctor knows if you have had any other cancer treatments or radiation therapy within the past 4 weeks.

Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Black, tarry stools
bleeding gums
blood in the urine or stools
chest pain
cough or hoarseness, accompanied by fever or chills
fever or chills
lower back or side pain, accompanied by fever or chills
painful or difficult urination, accompanied by fever or chills
pinpoint red spots on the skin
shortness of breath
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Itching
joint pain
large, swollen hives
skin rash
swelling of the feet or lower legs
Rare
Blistering, peeling, or loosening of the skin
diarrhea
muscle pain
muscle twitching
red skin lesions, often with a purple center
red, irritated eyes
seizures
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
sore throat
sudden jerky movements of the body
unsteadiness, trembling, or other problems with muscle control or coordination
Incidence not known
Abdominal or stomach pain or tenderness
bone pain
clay colored stools
dark urine
decreased appetite
difficult breathing
headache
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
trouble getting pregnant
troubled or quick, shallow breathing
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Changes in menstrual period
nausea and vomiting
Rare
Anxiety
confusion
dry mouth
hyperventilation
irregular heartbeats
irritability
no muscle tone or movement
restlessness
seeing, hearing, or feeling things that are not there
trouble sleeping
Incidence not known
Hives or welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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