Pronunciation:

klor-AM-byoo-sil

Brand Names:

• Leukeran

Dosage Forms:

• Tablet

Warnings:

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

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 cancer of the blood and lymph system. It may also be used to treat other kinds of cancer, as determined by your doctor.

Chlorambucil interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by chlorambucil, other effects will 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 not occur for months or years after the medicine is used.

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

Chlorambucil may also be used for other conditions as determined by your doctor.

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

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—

In general, this medicine has not been shown to cause different side effects or problems in children than it does in adults. However, some children with nephrotic syndrome (a kidney disease) may be more likely to have convulsions (seizures).

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of chlorambucil in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies 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—

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

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:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Convulsions (seizures) (history of) or
• Head injury—Increased risk of seizures

• Gout or
• Kidney stones (history of)—Chlorambucil may increase levels of uric acid in the body, which can cause gout or kidney stones

• Bone marrow depression or
• Infection—Chlorambucil decreases your body's ability to fight infection
• Previous failure of chlorambucil therapy—Repeat treatment with chlorambucil not recommended

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 health care professional 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 health care professional 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.

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.

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 and to check for unwanted effects.

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 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.

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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

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

More Common

Black, tarry stools

blood in urine or stools

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 skin

unusual bleeding or bruising

Less common

Large, swollen hives

itching

skin rash

sores in mouth and on lips

Rare

Cough

blisters on skin

muscle twitching or jerking

shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Joint pain

swelling of feet or lower legs

Rare

Agitation

confusion

convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

tremors

trouble in walking

weakness (severe) or paralysis

yellow eyes or skin

Symptoms of overdose (in the order of frequency)

Black, tarry stools

blood in urine or stools

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 skin

unusual bleeding or bruising

agitation

convulsions (seizures)

trouble in walking

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

itching of skin

nausea and vomiting

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Black, tarry stools

blood in urine or stools

cough or hoarseness (may be 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 skin

shortness of breath

unusual bleeding or bruising

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