Bufatas

Busulfan

Conditioning treatment prior to conventional haematopoietic progenitor cell transportation (HPCT) followed by cyclophosphamide; following fludarabine in adults; followed by cyclophosphamide or melphalan in paed patients.

In combination w/ cyclophosphamide or melphalan Adult 0.8 mg/kg as 2-hr infusion every 6 hr over 4 consecutive days for total of 16 doses followed by cyclophosphamide 60 mg/kg daily over 2 days for at least 24 hr following 16th dose of busulfan. Paed 0-17 yr weighing >34 kg 0.8 mg/kg, >23-34 kg 0.95 mg/kg, 16-23 kg 1.1 mg/kg, 9 to <16 kg 1.2 mg/kg, <9 kg 1 mg/kg. Each dose followed by 4 cycles of 50 mg/kg cyclophosphamide + 140 mg/m² melphalan for at least 24 hr following 16th dose of busulfan. In combination w/ fludarabine Fludarabine 30 mg/m² as single daily 1-hr infusion for 5 consecutive days or 40 mg/m² for 4 consecutive days then immediately administer busulfan 3.2 mg/kg as single daily 3-hr infusion for 2 or 3 consecutive days. Obese patient Use ideal body wt.

Hypersensitivity. Pregnancy.

Not to be given by rapid IV, bolus or peripheral inj. Myelosuppression; severe granulocytopenia, thrombocytopenia, anemia; hepatic veno-occlusive disease; acute resp distress syndrome w/ subsequent resp failure associated w/ pulmonary fibrosis. Increased risk of 2nd malignancy. Leukemogenic. Patients w/ prior history of mediastinal or pulmonary radiation; seizures. Patients who received prior RT, ≥3 chemotherapy cycles or prior progenitor cell transplant. Frequently monitor CBC including differential WBC & platelet counts during treatment & until recovery. Regularly monitor serum transaminases, alkaline phosphatase & bilirubin 28 days following transplant; cardiac function. Periodically monitor renal function. Consider prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) for prevention & management of infections; platelet & RBC support, granulocyte colony stimulating agent. Premed w/ anticonvulsants when used in high doses & administer 12 hr prior to treatment, to 24 hr after last dose. Concurrent or prior use (<72 hr) w/ paracetamol. Not recommended in patients w/ renal impairment. Pre-existing & severe liver impairment. May impair fertility. Men are advised not to father a child during & up to 6 mth after treatment & seek advice on sperm cryo-conservation prior to treatment. Women of childbearing potential should use effective contraception during & up to 6 mth after treatment. Ovarian suppression & amenorrhoea w/ menopausal symptoms in pre-menopausal patients. Discontinue lactation during treatment. Fanconi anaemia in childn. Not recommended in obese childn & adolescents w/ BMI >30 kg/m². Neonates. Childn <9 kg. Prevented onset of puberty in pre-adolescent girl. Elderly >60 yr.

In combination w/ cyclophosphamide or melphalan: Rhinitis, pharyngitis; neutropenia, thrombocytopenia, febrile neutropenia, anaemia, pancytopenia; allergic reaction; anorexia, hyperglycaemia, hypocalcaemia, hypokalaemia, hypomagnesaemia, hypophosphatemia; anxiety, depression, insomnia; headache, dizziness; tachycardia; HTN, hypotension, thrombosis, vasodilatation; dyspnoea, epistaxis, cough, hiccup; stomatitis, diarrhoea, abdominal pain, nausea, vomiting, dyspepsia, ascites, constipation, anal discomfort; hepatomegaly, jaundice; rash, pruritus, alopecia; myalgia, back pain, arthralgia; dysuria, oliguria; asthenia, chills, fever, chest pain, oedema, general pain oedema, inj site pain or inflammation, mucositis; increased transaminases, bilirubin, γ-glutamyl transferase, alkaline phosphatases & wt, abnormal breath sounds, elevated creatinine. Hyponatraemia; confusion; arrhythmia, atrial fibrillation, cardiomegaly, pericardial effusion, pericarditis; hyperventilation, resp failure, alveolar & pulmonary haemorrhages, asthma, atelectasis, pleural effusion; haematemesis, ileus, oesophagitis; veno occlusive liver disease in ped; skin desquamation, erythema, pigmentation; haematuria, moderate renal insufficiency; increased BUN, decreased ejection fraction. In combination w/ fludarabine: Viral & bacterial infection, cytomegalovirus & EBV reactivation; hypoalbuminaemia, electrolyte disturbance, hyperglycaemia; nausea, vomiting, diarrhoea, stomatitis; haemorrhagic cystitis induced by viral infection; mucositis; increased transaminases, bilirubin & alkaline phosphatase. Invasive fungal & pulmonary infection; headache; HTN; pulmonary haemorrhage; rash; renal disorder; elevated creatinine.

Reduced/decreased clearance w/ itraconazole; paracetamol. High plasma levels w/ ketobemidone. Increased clearance w/ phenytoin.

Cytotoxic Chemotherapy

L01AB01 - busulfan ; Belongs to the class of alkylating agents, alkyl sulfonates. Used in the treatment of cancer.

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