Monograph Details
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Neoplasms
> Alkylating agents
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BUSULFEX |
| Manufacturer |
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Otsuka America Pharmaceutical, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Alkylating agent. |
| Generic Name |
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Busulfan 6mg/mL; soln for IV administration after dilution. |
| Indications |
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In combination with cyclophosphamide, as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. |
| Children |
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See literature. |
| Adults |
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See literature. Premedicate with phenytoin and antiemetics. Give by IV infusion over 2 hours. 0.8mg/kg of ideal body weight or actual body weight, whichever is lower, every 6 hours for 4 days (total of 16 doses). Obese: base dose on adjusted ideal body weight. |
| Precautions |
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Myelosuppression. Seizure disorder. Head trauma. Renal or hepatic impairment. Obtain CBCs with differential, platelet count, liver enzymes, bilirubin during treatment and until recovery. Monitor for infection and bleeding. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended. |
| Interactions |
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Potentiated by itraconazole and acetaminophen. May be antagonized by phenytoin. Caution with potentially epileptogenic drugs. |
| Adverse Reactions |
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Myelosuppression (eg, granulocytopenia, thrombocytopenia, anemia), GI upset, stomatitis, anorexia, abdominal pain, dyspepsia, fever, headache, asthenia, chills, pain, tachycardia, hypertension, edema, dyspnea, dizziness, depression, elevated creatinine, hypomagnesemia, hyperglycemia, hypokalemia, hypocalcemia, hyperbilirubinemia, insomnia, anxiety, rhinitis, rash; seizures (with higher doses), hepatic veno-occlusive disease, cardiac tamponade (in pediatric patients with thalassemia); rare: bronchopulmonary dysplasia with pulmonary fibrosis. |
| How Supplied |
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Single-use vials (10mL)—8 |
| Additional Resources |
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• Related Prescribing Note |
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