Busulfan, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth to treat chronic myelogenous leukemia. Take it exactly as directed. The injection form of this medicine is used to prepare for a stem cell transplant when you have CML.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause lung disease or a second cancer. It may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: busulfan, oral; Myleran; busulfan, injection; Busulfex

What is this medicine used for?

This medicine is taken by mouth to treat chronic myelogenous leukemia (CML). The injection form of this medicine is used to prepare for a stem cell transplant when you have CML.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A severe head injury
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Liver problems
• Lung disease
• Seizures

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Talk with your healthcare provider about effective birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

Males: This medicine may damage your sperm. Use condoms or other effective birth control during treatment with this medicine.

How do I take it?

Oral tablets: This is a strong medicine that must be taken exactly as directed by your healthcare provider. During treatment you must have blood tests regularly to avoid serious side effects. Keep all your appointments, and make dosage changes as directed. Also, stop taking this medicine when your healthcare provider tells you to do so.

Check with your healthcare provider before using this medicine in children. The dose must be carefully calculated based on weight.

Take this medicine at the same time every day, with or without food. Your healthcare provider may have you drink extra fluids every day.

Injection: This medicine is given by IV infusion (slow drip through a needle into a large vein) by healthcare providers experienced in stem cell transplants. You will receive this medicine where you can be carefully monitored.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: mouth sores, nausea, vomiting, diarrhea, seizures.

What should I watch out for?

This medicine may lower the number of certain types of blood cells in your body. You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests. Tell your healthcare provider right away if you have any signs of infection, or unusual bruising or bleeding.

Rarely, this medicine may cause lung disease or a second cancer. Talk to your healthcare provider about this.

This medicine can darken your skin, especially if you have a dark complexion.

Females: This medicine may cause you to stop having periods. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding, fever, sore throat, cough, mouth sores, congestion, shortness of breath, chest pain, fast or irregular heartbeat, seizures, pain in your side, back pain, muscle pain or weakness, joint pain, severe stomach pain, severe nausea or vomiting, unusual tiredness or weakness, loss of appetite, weight loss, unexplained loss of appetite, dark-colored urine, light-colored bowel movements, darkened skin, vision changes, confusion, severe dizziness or fainting, changes in urination, painful urination, increased thirst or hunter, depression or other mood changes; swelling, redness, or pain in arms or legs.

Other: Diarrhea, constipation, hair loss, dizziness, nausea, vomiting, dry mouth, missed menstrual periods, flushing, irritation or swelling around the injection site.

What products might interact with this medicine?

Do not take any other medicines unless they are approved by the healthcare provider who prescribed this medicine.

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Aspirin and other salicylates
• Clozapine (Clozaril, FazaClo)
• Cyclophosphamide (Cytoxan) and other cancer medicines
• Live vaccines
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), lepirudin (Refludan), tirofiban (Aggrastat), and warfarin (Coumadin)
• Metronidazole
• Natural remedies such as echinacea and St. John's wort
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Thioguanine (Tabloid)

Do not drink alcohol while taking this medicine. Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

Do not take any other medicines unless they are approved by the healthcare provider who prescribed this medicine.

How should I store this medicine?

Store this medicine at room temperature Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.