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Myleran Warnings and Precautions

Before beginning chemotherapy treatment with Myleran, you should understand that this drug may cause potentially dangerous lung problems, seizures, and other complications. Other warnings and precautions with Myleran involve being aware of drug interactions, allergic reactions, and possible risks for women who are pregnant or nursing.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to taking Myleran® (busulfan) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Lung disease
  • A seizure disorder
  • A history of head trauma
  • Had radiation treatment or previous chemotherapy
  • 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 With Myleran

Some warnings and precautions to be aware of prior to using this medication include the following:

  • Myleran can cause significant side effects. It should only be given under the supervision of a healthcare provider who has experience using chemotherapy medicines. Your healthcare provider will weigh the risks and benefits of using this medicine before recommending treatment for your particular situation.
  • Like other chemotherapy medicines, Myleran 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, including:
  • Your healthcare provider will monitor your blood cell counts regularly during treatment. Let him or her know if you experience signs of bone marrow suppression, such as:
    • Abnormal bleeding or bruising
    • Fever
    • Chills
    • Body aches and pains
    • Sore throat or cough
    • Fatigue and weakness
    • Shortness of breath
    • Pale skin.
  • Myleran can cause a rare but life-threatening lung problem referred to as "busulfan lung." Busulfan is the active ingredient in Myleran. This lung problem has been reported to occur anywhere from 8 months to 10 years after Myleran treatment. Let your healthcare provider know if you develop any symptoms of busulfan lung, such as:
    • Cough
    • Fever
    • Shortness of breath.
  • There have been reports of seizures occurring in people taking this medication. People who have a seizure disorder or who have had a head trauma may be at a greater risk for seizures during Myleran treatment. Your healthcare provider may give you anti-seizure medicines to prevent seizures from occurring.
  • This medicine may increase your risk for developing other types of cancer, including cancerous tumors and leukemia, especially when used for long periods of time.
  • Myleran can cause the ovaries to stop functioning properly in females, and the testicles to stop functioning in males, possibly leading to infertility (the inability to have children). Women who take the medicine may stop having menstrual periods, and men may experience a reduction in the size of their testicles. There is also the risk that young girls who take this medicine may not go through puberty.
  • This medicine may cause a liver problem known as veno-occlusive liver disease, which occurs when the tiny blood vessels in the liver become blocked. This problem is more likely to occur when Myleran is used in high doses, such as doses used for bone marrow transplant. Veno-occlusive liver disease can be life-threatening. Let your healthcare provider know if you develop signs of liver problems, such as:


    • Upper-right abdominal (stomach) pain
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
  • When used in high doses, this medicine has been associated with a life-threatening heart problem that 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. Some people may experience abdominal (stomach) pain and vomiting just prior to developing this heart problem.
  • Prolonged use of this medicine may cause adrenal insufficiency, a condition that occurs when the body's adrenal glands do not produce enough steroid hormones. Let your healthcare provider know if you develop symptoms of adrenal insufficiency, such as:
    • Sudden weakness
    • Unusual fatigue
    • Loss of appetite
    • Weight loss
    • Darkening of the skin
    • Nausea
    • Vomiting.
  • It is unknown if Myleran passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Myleran and Breastfeeding).
  • Myleran is a pregnancy Category D medication, which means it may cause fetal harm if used during pregnancy (see Myleran and Pregnancy).
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