Generic Medicine Info
May be taken with or without food. Take w/ chilled liqd, ensure adequate fluid intake.
Oral: Disease that demonstrated resistance to busulfan; patients without definitive diagnosis of chronic myeloid leukaemia. Lactation.
Special Precautions
Patient with compromised bone marrow reserve due to previous radiation therapy, prior chemotherapy of ≥3 cycles, prior stem cell transplantation; history of seizures, predisposition to seizures, head trauma, receiving epileptogenic drugs; hyperuricaemia or hyperuricosuria, acute porphyria, thalassaemia, Fanconi's anaemia. Obese patient. Considered ineffective once in blast crisis phase. Premedicate with prophylactic anticonvulsants (e.g. benzodiazepines, levetiracetam) and antiemetics if high-dose treatment for haematopoietic stem cell transplantation (HSCT) is prescribed. Patient with chronic myeloid leukaemia who lacks Philadelphia (Ph1) chromosome. Renal and hepatic impairment. Children and elderly. Pregnancy. Concomitant immunisation using live vaccines during therapy is not recommended. Monitoring Parameters Determine pregnancy status before treatment initiation. Monitor CBC with differential and platelet count daily until engraftment for HSCT or weekly for palliative therapy; LFTs (transaminases, alkaline phosphatase, bilirubin) daily for at least 28 days after transplant; cardiac and renal function regularly. Assess for signs and symptoms of sinusoidal obstruction syndrome, cardiac tamponade, adverse haematologic and pulmonary effects during and for several months after treatment. Monitoring of drug levels during conditioning treatment prior to haematopoietic progenitor cell transplantation is recommended.
Adverse Reactions
Significant: Secondary malignancies (e.g. malignant tumours, acute leukaemia, chromosomal alterations); cellular dysplasia in some organs (e.g. giant hyperchromatic nuclei in lymph nodes, adrenal glands, thyroid gland, liver, pancreas, bone marrow); infertility (temporary or permanent), ovarian suppression and amenorrhoea with menopausal symptoms in premenopausal patient; ovarian failure, including failure to achieve puberty in young females; impotence, sterility, azoospermia, and testicular atrophy in males; gastrointestinal toxicity (e.g. nausea, vomiting), seizures (high dose), hyperpigmentation. Cardiac disorders: Tachycardia, atrial fibrillation, pericarditis, cardiomegaly, arrhythmia, pericardial effusion, chest pain. Eye disorders: Rarely, cataract, lens disorder, corneal thinning. Gastrointestinal disorders: Diarrhoea, stomatitis, haematemesis, oesophagitis, dyspepsia, hiccup, constipation, ileus, anorectal discomfort, abdominal pain. General disorders and administration site conditions: Chills, pyrexia, asthenia, pain or inflammation at inj site, mucositis. Hepatobiliary disorders: Biliary fibrosis with hepatic atrophy and necrosis; jaundice, ascites, hepatomegaly. Immune system disorders: Hypersensitivity. Investigations: Increased transaminases, bilirubin, blood creatinine, BUN and weight; decreased ejection fraction, abnormal breath sounds. Metabolism and nutrition disorders: Anorexia, hypocalcaemia, hyperglycaemia, hypokalaemia, hypophosphataemia, hyponatraemia, hypomagnesaemia, oedema. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, back pain. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Depression, anxiety, insomnia, confusional state. Renal and urinary disorders: Haemorrhagic cystitis, dysuria, oliguria, haematuria, moderate renal insufficiency. Respiratory, thoracic and mediastinal disorders: Idiopathic pneumonia syndrome, dyspnoea, cough, epistaxis, rhinitis, pharyngitis, hyperventilation, asthma, atelectasis, pleural effusion. Skin and subcutaneous tissue disorders: Alopecia, rash, pruritus, desquamation. Vascular disorders: Hypertension, hypotension, vasodilatation, thrombosis.
Potentially Fatal: Severe and prolonged bone marrow suppression (e.g. leucopenia, thrombocytopenia, neutropenia, anaemia, bone marrow failure, pancytopenia); hyperbilirubinaemia, hepatic sinusoidal obstruction syndrome (formerly hepatic veno-occlusive disease), cardiac tamponade in patient with thalassaemia (high oral dose); thrombotic microangiopathy (high IV dose). Rarely, bronchopulmonary dysplasia with pulmonary fibrosis or "busulfan lung" (prolonged use).
Drug Interactions
Concomitant immunisation with live vaccines may cause infections in immunocompromised patients. Reduced clearance resulting in increased plasma levels and risk of toxicity with itraconazole and metronidazole. Clearance may be decreased by paracetamol and cyclophosphamide. Additive myelosuppression and pulmonary toxicity with other myelosuppressive and cytotoxic agents, respectively. Increased clearance resulting in decreased serum levels with phenytoin. May cause oesophageal varices with tioguanine.
ATC Classification
L01AB01 - busulfan ; Belongs to the class of alkylating agents, alkyl sulfonates. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on busulfan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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