Composition
Per Vial: Busulfan 60 mg/10 ml concentrated solution for IV infusion
Indications & Dosage
Chronic myeloid leukaemia, induction of remission: BY IV INF OR ORAL: Adult: (consult local protocol). Conditioning treatment before haematopoietic progenitor cell transplantation: BY IV INF OR ORAL: Adult: (consult local protocol). Conditioning treatment before haematopoietic progenitor cell transplantation in patients who are candidates for a reduced-intensity conditioning (RIC) regimen: BY IV INF: Adult: (consult local protocol).
Administration
Administered as central IV infusion after dilution of each vial. Each infusion will last for 2 hrs. Busulfan will be administered every 6 hours during for conscutive days prior to transplant.
Compatibility
Dilution in Dextrose 5, NS 9mg/ml
Stability
Store unopened vials in 2C-8C
Precautions
Avoid in Acute porphyrias, history of seizures and high dose; antiepileptic prophylaxis required, use anticulsant and antiemetic before starting treatment. ineffective once in blast crisis phase, previous progenitor cell transplant, previous radiation therapy, risk of second malignancy. three or more cycles of chemotherapy. Use effective contraception during and for 6 months after treatment in men or women. Caution in hepatic impairment; monitor hepatic function, especially following transplant, renal impairment. Monitor cardiac and liver function, frequent blood tests are necessary because excessive myelosuppression may result in irreversible bone-marrow aplasia.
Interactions
Itraconazole, Metronidazole, Ketobemidone, Deferasiroks, Paracetamol.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Alopecia, diarrhoea, hepatic disorders, nausea, respiratory disorders, sinusoidal obstruction syndrome, skin reactions, thrombocytopenia, vomiting, anaemia, anxiety, arrhythmias, arthralgia, ascites, asthenia, asthma, cardiomegaly, confusion, depression, dizziness, dyspnoea, dysuria, embolism and thrombosis, GI disorders, haemorrhage, headache, hiccups, hyperglycaemia, hypersensitivity, hypertension, hypoalbuminaemia, hypotension, increased risk of infection, insomnia, mucositis, myalgia, nervous system disorder, neutropenia, oedema, pain, pancytopenia, pericardial effusion, pericarditis, reactivation of infections, renal disorder, renal impairment, stomatitis, vasodilation, ovarian failure. premature menopause, sepsis. Rare: Dry mouth, seizure, eye disorders, erythema nodosum, gynaecomastia, myasthenia gravis, Sjogren’s syndrome, hypogonadism.