Myleran Generic Name & Formulations
Legal Class
Rx
General Description
Busulfan 2mg; tabs.
Pharmacological Class
Alkylating agent.
How Supplied
Tabs—25
Manufacturer
Myleran Indications
Indications
Palliative treatment of chronic myelogenous leukemia.
Myleran Dosage and Administration
Adult
Remission induction: 4–8mg/day or 60micrograms/kg or 1.8mg/m2, daily. Reserve doses >4mg/day for severe cases. Reduce dose or discontinue at first sign of reduced bone marrow reserve. Discontinue before leukocyte count normalizes; see literature. Normal leukocyte counts usually achieved in 12–20 weeks. If remission <3 months, maintenance therapy of 1–3mg/day may be advisable.
Children
Remission induction: 60micrograms/kg or 1.8mg/m2, daily. Reduce dose or discontinue at first sign of reduced bone marrow reserve. Discontinue before leukocyte count normalizes. Normal leukocyte counts usually achieved in 12–20 weeks. See literature.
Myleran Contraindications
Not Applicable
Myleran Boxed Warnings
Not Applicable
Myleran Warnings/Precautions
Warnings/Precautions
Confirm diagnosis. Monitor hepatic and bone marrow function. Obtain CBCs and differential weekly; monitor for anemia. Previously compromised bone marrow (irradiation, chemotherapy). Seizure disorder or risk. Head trauma. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended.
Myleran Pharmacokinetics
See Literature
Myleran Interactions
Interactions
Myelosuppression increased with other myelosuppressives. Increased pulmonary toxicity with other cytotoxic drugs. Potentiated by itraconazole, cyclophosphamide (see literature). May be antagonized by phenytoin. Hepatotoxicity possible with long-term continuous thioguanine therapy. Caution with drugs that lower seizure threshold.
Myleran Adverse Reactions
Adverse Reactions
See literature. Bone marrow suppression (eg, pancytopenia, anemia, leukopenia, thrombocytopenia, aplastic anemia), pulmonary toxicity, cellular dysplasia, malignant tumors, acute leukemias, cardiac tamponade (esp. in thalassemia), hyperpigmentation, adrenal insufficiency, seizures, hepatic veno-occlusive disease, infection (eg, pneumonia, sepsis), mucositis, myasthenia gravis, gonadal suppression, rash; rare: cataracts, bronchopulmonary dysplasia (discontinue if occurs).
Myleran Clinical Trials
See Literature
Myleran Note
Not Applicable
Myleran Patient Counseling
See Literature