Indication & Safety Information for MYLERAN® (Busulfan)
Patients should never be allowed to take MYLERAN® without medical supervision and should consult their physician if they experience fever, sore throat, signs of local infection, bleeding from any site, or symptoms suggestive of anemia. Any one of these findings may indicate busulfan toxicity; however, they may also indicate transformation of the disease to an acute “blastic” form. Women of childbearing potential should be advised to avoid becoming pregnant.
WARNING:
MYLERAN® is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy.
MYLERAN® can induce severe bone marrow hypoplasia. Reduce or discontinue the dosage immediately at the first sign of any unusual depression of bone marrow function as reflected by an abnormal decrease in any of the formed elements of the blood. A bone marrow examination should be performed if the bone marrow status is uncertain.
SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED LEUKEMOGENESIS IN HUMANS.
INDICATIONS AND USAGE
MYLERAN® is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
CONTRAINDICATIONS
MYLERAN® is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established.
MYLERAN® is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
Indication & Safety Information for MYLERAN® (Busulfan)
Patients should never be allowed to take MYLERAN® without medical supervision and should consult their physician if they experience fever, sore throat, signs of local infection, bleeding from any site, or symptoms suggestive of anemia. Any one of these findings may indicate busulfan toxicity; however, they may also indicate transformation of the disease to an acute “blastic” form. Women of childbearing potential should be advised to avoid becoming pregnant.
WARNING:
MYLERAN® is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy.
MYLERAN® can induce severe bone marrow hypoplasia. Reduce or discontinue the dosage immediately at the first sign of any unusual depression of bone marrow function as reflected by an abnormal decrease in any of the formed elements of the blood. A bone marrow examination should be performed if the bone marrow status is uncertain.
SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED LEUKEMOGENESIS IN HUMANS.
INDICATIONS AND USAGE
MYLERAN® is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
CONTRAINDICATIONS
MYLERAN® is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established.
MYLERAN® is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.
SIDE EFFECTS
Common Side Effects
- darkening skin
- dry mouth
- headache
- diarrhea
- constipation
- nausea
- vomiting
- upset stomach
- flushing (warmth, redness, or tingly feeling)
- swelling or irritation around the IV needle
- missed menstrual periods
- hair loss
- fatigue
- loss of appetite
- weight loss
- weakness
- dizziness
Serious Side Effects
Contact your doctor immediately if you experience any of the following:
- signs of liver disease (such as persistent nausea or vomiting, severe stomach or abdominal pain, yellowing skin/eyes, dark urine)
- seizures
- unusual or extreme tiredness
- painful urination
- toe or joint pain
- fainting
- fast or pounding heartbeat
- cloudy or blurred vision
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.