Busulfex Warnings and Precautions

If you have problems with your liver, kidneys, or lungs, it may not be safe for you to start treatment with Busulfex. Having certain medical conditions during chemotherapy treatment with this drug may increase your risk for complications, such as lung disease, bleeding, and other serious problems. Other precautions for using Busulfex safely include warnings for women who are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to receiving Busulfex® (busulfan injection) if you have:
 
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure
  • Lung disease
  • A seizure disorder
  • Ever had head trauma (such as a head injury)
  • Had prior radiation treatment, chemotherapy, or stem cell or bone marrow transplant
  • Thalassemia (an inherited blood disorder)
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings for Busulfex

Some warnings and precautions to be aware of prior to using this drug include the following:
 
  • Busulfex can cause significant side effects. It should only be given under the supervision of a healthcare provider who has experience in stem cell transplants. It should also only be used in a healthcare setting that is equipped to treat any complications or side effects that occur during treatment.
 
  • Like other chemotherapy medicines, Busulfex can cause significant bone marrow depression (when the bone marrow is unable to make normal amounts of red blood cells, white blood cells, and platelets). This can lead to serious problems, such as:
     
Your healthcare provider will monitor your blood cell counts regularly during treatment, and possibly give you other treatment, such as a blood transfusion or antibiotics, if your blood cell counts drop too low.
  • Let your healthcare provider know if you experience signs of bone marrow depression, such as:
 
    • Abnormal bleeding or bruising
    • A fever
    • Chills
    • Body aches and pains
    • Sore throat or cough
    • Fatigue and weakness
    • Shortness of breath
    • Pale skin.
 
  • People who are treated with Busulfex may develop serious lung disease after treatment has ended. Lung disease has been reported to occur anywhere from 4 months to 10 years after treatment. Let your healthcare provider know right away if you develop any symptoms of lung disease, such as:
 
    • Cough
    • Fever
    • Shortness of breath.
 
  • Busulfex may cause seizures, even in people who have never had a seizure before. You will likely be given an anti-seizure medicine known as phenytoin (Phenytek®, Dilantin®) to help prevent seizures from occurring during treatment.
 
  • This medicine may increase your risk for developing other types of cancer, including cancerous tumors and leukemia. These other cancers may occur years after treatment has ended.
 
  • Busulfex may cause infertility, which could be irreversible. Women may stop having menstrual periods during treatment, and men may experience a reduction in the size of their testicles.
 
  • This medicine may cause a life-threatening liver problem known as veno-occlusive liver disease, which occurs when the tiny blood vessels in the liver become blocked. People who have had prior radiation treatment, chemotherapy, or stem cell transplant may have a greater risk for developing this problem. Let your healthcare provider know if you develop signs of liver damage, such as abdominal (stomach) pain or a yellowish color to your skin or the whites of your eyes.
 
  • There have been reports of a life-threatening heart problem called cardiac tamponade occurring in children with a condition known as thalassemia who receive Busulfex before a stem cell transplant. Cardiac tamponade occurs when blood or fluid collects in the sac that surrounds the heart. The blood and fluid places pressure on the heart, preventing it from functioning properly. Most children had abdominal (stomach) pain and vomiting just prior to developing this heart problem. If your child receives Busulfex, let his or her healthcare provider know if stomach pain or vomiting occurs.
 
 
  • It is unknown if Busulfex passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Busulfex and Breastfeeding).
 
  • Busulfex is a pregnancy Category D medication, which means it may cause fetal harm when used during pregnancy (see Busulfex and Pregnancy).
 
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