When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to busulfan, or if you are pregnant.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not crush, break, or chew it. Drink plenty of fluids while you are taking this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how busulfan works. Tell your doctor if you are taking itraconazole or thioguanine.

Warnings While Using This Medicine:

• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have thalassemia, myasthenia gravis, a history of seizures or head injury, or if you ever had chemotherapy or radiation treatments.
• This medicine may cause the following problems:
  
  • A rare but serious lung problem, which may develop months or years after you stop taking the medicine
  • An increased risk for other kinds of cancer, or for a recurrence of leukemia
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Chest pain or pressure, trouble breathing
• Coughing up blood
• Loss of appetite, nausea, vomiting, weight loss, darkening of your skin
• Seizures
• Unusual bleeding, bruising, or weakness, pale skin

If you notice these less serious side effects, talk with your doctor:

• Change in your menstrual periods, or breast swelling
• Dry mouth, nose, or eyes, decreased sweating
• Hair loss
• Skin rash
• Vision problems

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088