Busulfex

Inform patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if fever develops [see WARNINGS AND PRECAUTIONS].

Inform patients of the risks associated with the use of BUSULFEX as well as the plan for regular blood monitoring during therapy. Specifically inform patients of the following: The risk of venoocclusive liver disease [see WARNINGS AND PRECAUTIONS].

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Advise females and males of reproductive potential to use effective contraception during and after treatment with BUSULFEX [see Use in Specific Populations].

Advise females to discontinue breastfeeding during treatment with BUSULFEX [see Use in Specific Populations].

Advise females and males of reproductive potential that BUSULFEX may cause temporary or permanent infertility [see Use in Specific Populations].

Oral:

Busulfan is a prescription medication used to treat a certain type of chronic myelogenous leukemia, or CML. CML is a type of cancer of the white blood cells.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Injectable: 

Busulfan is a prescription medication used in combination with other medications to destroy bone marrow and cancer cells in preparation for a bone marrow transplant in patients with chronic myelogenous leukemia, or CML. CML is a type of cancer of the white blood cells.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Common side effects of busulfan include:

• nausea
• diarrhea
• loss of appetite
• weight loss
• constipation
• sores in the mouth and throat
• dry mouth
• headache
• difficulty falling asleep or staying asleep
• feeling unusually anxious or worried
• dizziness
• swelling of the face, arms, hands, feet, ankles or lower legs
• chest pain
• joint, muscle or back pain
• rash
• itching and dry skin
• darkened skin
• hair loss
• black, tarry stools
• red urine
• vomiting

This is not a complete list of busulfan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking busulfan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to busulfan or to any of its ingredients
• have previously received radiation therapy or treatment with other chemotherapy medications or if you have or have ever had seizures or a head injury
• have taken busulfan before, but your cancer did not respond to the medication
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Busulfan is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Busulfan taken by mouth is used to treat the symptoms of chronic myelogenous leukemia (a type of blood cancer). Busulfan injection is used together with a medicine called cyclophosphamide, to prepare your body to receive a stem cell transplant from a donor's bone marrow.

Busulfan is not a cure for leukemia.

Busulfan may also be used for purposes not listed in this medication guide.

You should not use busulfan if you are allergic to it.

To make sure you can safely take busulfan, tell your doctor if you have:

• a weak immune system (bone marrow depression) caused by other cancer medications or radiation treatment;

• epilepsy or other seizure disorder;

• history of head injury; or

• a history of lung or breathing problems.

Some people treated with busulfan have developed new forms of cancer. Talk to your doctor about your specific risks and benefits of using this medicine.

Do not use busulfan if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Busulfan may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether busulfan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Busulfan injection is used in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for treatment of chronic myelogenous leukemia.

Busulfan belongs to the group of medicines known as alkylating agents. It 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 benefits this medicine will do as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

• Tell all of your health care providers that you take Busulfex. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Other types of cancer may rarely happen later in life.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Chance of seizures may be higher. Talk with the doctor.
• Cataracts may rarely happen.
• A very bad and sometimes deadly heart problem has happened with some people taking Busulfex. Most of the time, stomach pain and throwing up happened before the heart problem. Talk with the doctor.
• Very bad and sometimes deadly lung problems have happened with this medicine. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• Very bad and sometimes deadly liver problems have happened with Busulfex. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. In both men and women, this may go back to normal but sometimes it may not. Talk with your doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for some time after care ends. Use birth control that you can trust. Talk with your doctor to see how long to use birth control after you stop this medicine.
• If you are a man and your sex partner gets pregnant while you take Busulfex or within several months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy during care and for some time after care ends. Talk with your doctor to see how long to use birth control after you stop this medicine.
• If you get pregnant while taking Busulfex or within several months after the last dose, call your doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry mouth.
• Anxiety.
• Back pain.
• Hard stools (constipation).
• Flushing.
• Headache.
• Runny nose.
• Feeling tired or weak.
• Not able to sleep.
• Upset stomach or throwing up.
• Mouth irritation or mouth sores.
• Not hungry.
• Belly pain or heartburn.
• Loose stools (diarrhea).
• Dizziness.
• Irritation or swelling where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Since busulfan injection is given by a healthcare professional, you are not likely to miss a dose.

Applies to busulfan: intravenous solution

Along with its needed effects, busulfan (the active ingredient contained in Busulfex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking busulfan:

• Black, tarry stools
• bloated abdomen or stomach
• blood in the urine or stools
• blurred vision
• chest pain
• cough or hoarseness
• dizziness
• fast or irregular breathing
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• headache
• lower back or side pain
• nervousness
• pain and fullness in the upper abdominal or stomach
• painful or difficult urination
• pinpoint red spots on the skin
• pounding in the ears
• skin rash or itching
• slow heartbeat
• swelling of the eyes or eyelids
• tightness in the chest
• trouble breathing
• unusual bleeding or bruising
• weight gain
• yellow eyes and skin

• seizures

Some side effects of busulfan 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:

• Acid or sour stomach
• back pain
• belching
• bloody nose
• depression
• diarrhea
• difficulty having a bowel movement (stool)
• fear
• heartburn
• indigestion
• loss of appetite
• lack or loss of strength
• sneezing
• stomach discomfort or upset
• stuffy nose or runny nose
• swelling or inflammation of the mouth
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• trouble sleeping