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|Myleran

BUSULFAN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Myleran
• Busulfex

In Canada—

• Myleran

Category

• Antineoplastic

Description

Busulfan (byoo-SUL-fan) belongs to the group of medicines known as alkylating agents. It is used to treat some kinds of cancer of the blood. It may also be used as a conditioning regimen prior to progenitor cell transplantation for treatment of chronic myelogenous leukemia.

Busulfan seems to act by interfering with the function of the bone marrow. Since the growth of normal body cells may also be affected by busulfan, 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 busulfan, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Busulfan is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

• Parenteral
• Injection (U.S.)

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 busulfan, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to busulfan.

Pregnancy—Although only one case has been reported, there is a chance that this medicine may cause birth defects if either the male or the female is taking it at the time of conception or if it is taken during pregnancy. In addition, many cancer medicines may cause sterility which could be permanent. Sterility may occur with busulfan and the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are taking busulfan. Tell your doctor right away if you think you have become pregnant while taking busulfan.

Breast-feeding—It is not known whether busulfan passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are taking it.

Children—Although there is no specific information comparing use of busulfan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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. Although there is no specific information comparing use of busulfan in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 taking busulfan it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) or
• Acyclovir (e.g., Zovirax) or
• Amphotericin B by injection (e.g., Fungizone) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine you take by mouth) or
• Anti-infectives by mouth or by injection ( medicine for infection) or
• Antineoplastics (cancer medicine) or
• Antipsychotics (medicine for mental illness) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Captopril (e.g., Capoten) or
• Carbamazepine (e.g., Tegretol) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan)
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Gold salts (medicine for arthritis) or
• Imipenem and Cilastatin (e.g., Primaxin) or
• Inflammation or pain medicine, except narcotics or
• Interferon (e.g., Intron A, Roferon-A) or
• Itraconazole (e.g., Sporanox) or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Rheumatrex) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Plicamycin (e.g., Mithracin) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Busulfan may increase the effects of these medicines or radiation therapy on the blood

• Medicines that may increase your chance of having a seizure—Busulfan may increase the effect of these medicines.

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Busulfan may raise the amount of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not be as effective in patients taking busulfan

Other medical problems—The presence of other medical problems may affect the use of busulfan. 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

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

• Head injury or
• Convulsions (seizures, history of)—Busulfan injection and very high doses of oral busulfan can cause convulsions (seizures)

• Infection—Busulfan may decrease your body"s ability to fight infection
• Thalassemia—Busulfan may cause increased pressure within the heart in children

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.

Take each dose at the same time each day to make sure it has the best effect.

While you are taking this medicine, 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 taking 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 busulfan, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Handle and dispose of this medicine with care as directed by your doctor.

Dosing—The dose of busulfan will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient"s weight, and whether or not other medicines are also being taken. If you are taking busulfan at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of busulfan, ask your doctor.

Missed dose—If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with busulfan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Busulfan 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.

Busulfan 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some body tissue studies may be affected by this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may have 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 or nurse immediately if any of the following side effects occur:

Other 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:

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

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; shortness of breath; unusual bleeding or bruising

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

Revised: 08/29/2005

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