9.0 DRUG INFORMATION 
9.1 Busulfan (Myleran®, BU) NDC# 0081-0713-25 
Busulfan is available as Myleran® (Burroughs-Wellcome and Co.) in 2 mg 
scored tablets. It is impossible to prepare a parenteral form of the drug 
because it is insoluble in water. Oral preparations are well tolerated. 
Busulfan for this study will be given four times a day (q 6 hr) at a dose of 4 
mg/kg/day PO; four consecutive days prior to CTX administration. The dose 
is per kg of actual body weight or ideal body weight, whichever is less . Dose 
must be taken all at once and may be given through an NG tube. Please 
consult clinical nutrition (dietitian) for estimates of ideal body weight. 
9.1.1 Toxicity (BU) 
a) Hematologic - aplastic anemia. 
b) Addisonian-like syndrome with hyperpigmentation often 
unassociated with impaired corticosteriod production. 
c) Diffuse interstitial pneumonitis with fibrosis. 
d) Other toxic effects include erythematous skin rash, hepatic 
dysfunction, amenorrhea, testicular atrophy, gynecomastia, 
myasthenia symptoms and cataracts. 
e) , Nausea and vomiting can occur after busulfan but is generally 
mild. 
f) Generalized seizures have been reported after use of high dose 
busulfan. Patients will be treated with dilantin 5 mg/kg/dose (IV 
or PO) q 6 hr beginning on day -10 for 48 hr (8 doses), then 5 
mg/kg daily until day 4. Patients developing seizures should be 
extensively evaluated and treated as clinically indicated. 
9.1.2 Some patients may vomit after administration of busulfan. Since gastric 
absorption is good and fairly complete within 30 to 45 minutes, the 
following guidelines should be used to replace doses after emesis. 
a) Emesis within 30 minutes of the busulfan dose repeat one-half 
of the dose after giving an antiemetic. 
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Recombinant DNA Research, Volume 14 
