Busulfan Oral tablet

What is this medicine?

BUSULFAN (byoo SUL fan) is a chemotherapy drug. It is used to treat chronic myelogenous leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• head injury

• infection (especially virus infection such as chickenpox or herpes)

• liver disease

• low blood counts like low platelets, red blood cells, white blood cells

• lung or breathing disease, like asthma

• recent or ongoing radiation therapy

• seizures

• thalassemia

• an unusual or allergic reaction to busulfan, other chemotherapy agents, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• acetaminophen

• itraconazole

• medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim other chemotherapy drugs

• phenytoin

• thioguanine

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Do not become pregnant while taking this medicine or for a while after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for a while after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• breathing problems

• changes in vision

• cough

• darker skin color

• fast, irregular heartbeat

• mouth sores

• nausea, vomiting

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• swelling of the ankles, feet, hands, or other areas of the body

• unusually weak or tired

• yellowing of the eyes or skin

• weight loss

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry mouth

• dry skin

• hair loss

• headache

• joint or muscle aches

• missed menstrual periods

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Busulfan Solution for injection

What is this medicine?

BUSULFAN (byoo SUL fan) is a chemotherapy drug. It is used prior to a stem cell transplant in patients with chronic myelogenous leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• head injury

• infection (especially virus infection such as chickenpox or herpes)

• liver disease

• low blood counts like low platelets, red blood cells, white blood cells

• lung or breathing disease, like asthma

• recent or ongoing radiation therapy

• seizures

• thalassemia

• an unusual or allergic reaction to busulfan, other chemotherapy agents, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This medicine may interact with the following medications:

• acetaminophen

• itraconazole

• phenytoin

• live vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for a while after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for a while after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• nausea

• right upper belly pain

• seizures

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• swelling of the ankles, feet, hands or other areas of the body

• weight gain

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• headache

• feeling anxious

• mouth sores

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.