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.
This product is available in the following dosage forms: 10 mL single-use clear glass vials each containing 60 mg of busulfan at a concentration of 6 mg per mL for intravenous use.
2 What to Know Before Using
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population
Appropriate studies have not been performed on the relationship of age to the effects of busulfan injection in the pediatric population. Safety and efficacy have not been established.
Geriatric Population
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of busulfan injection in the elderly.
Pregnancy and Lactation
Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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 you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Fosphenytoin
Itraconazole
Ketobemidone
Phenytoin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:
Anemia or Bone marrow problems or Head injury or Seizures, history of or Thrombocytopenia (low number of platelets): Use with caution. May make these conditions worse.
Infections : May decrease your body's ability to fight infection.
Thalassemia: Busulfan may cause increased pressure within the heart in children.
3 Proper Usage
A nurse or other trained health professional will give you this medicine in a hospital.
This medicine is given through a needle placed in one of your veins.
Busulfan must be given slowly, so the needle will remain in place for 2 hours.
You may also receive medicines to help prevent seizures after using busulfan.
4 Precautions to Take
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep you or your sexual partner from getting pregnant during or after treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.
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 the 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.
This medicine may cause hepatic veno-occlusive disease (HVOD). This usually occurs if you receive too much busulfan, or receive this medicine before radiation treatment, or have a prior progenitor cell transplant. Call your doctor right away if you have a bloated abdomen or stomach, upper right abdominal or stomach pain, weight gain, or yellow eyes or skin. 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.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some body tissue studies may be affected by this medicine. Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children). Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
5 Potential Side 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:
More common:
Black, tarry stools bloated abdomen or stomach blood in the urine or stools
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
Incidence not known:
Seizures
Some 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:
Tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
Trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.
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