Myleran Tablet

Busulphan

2mg

Excella, Germany

Pack size	100's pack
Dispensing mode
Source
Agent
Retail Price	10.30 AED

Indications

Myleran Tablet is used for: Chronic myeloid leukaemia, Bone marrow transplantation, Polycythemia vera, Essential thrombocythemia,

Adult Dose

Oral Palliative treatment of chronic myeloid leukemia Adult: 60 mcg/kg daily. Maintenance: 0.5-2 mg daily. Max: 4 mg daily. Polycythemia vera Adult: 4-6 mg daily continued for 4-6 wk with blood counts monitoring. Essential thrombocythemia Adult: 2-4 mg daily. Conditioning regimens for bone marrow transplantation Adult: 3.5-4 mg/kg daily in divided doses for 4 days up to a total dose of 14-16 mg/kg. Usually used with cyclophosphamide for ablation of recipient's bone marrow.

Child Dose

Renal Dose

Administration

May be taken with or without food. Take w/ chilled liquid, ensure adequate fluid intake.

Contra Indications

Pregnancy and lactation. Hypersensitivity. Patients without definitive diagnosis of CML

Precautions

Bone marrow suppression is a common occurrence; reduce dose or discontinue oral administration for unusual suppression (bond marrow biopsy may be necessary); hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of prolonged myelosuppression Monitoring is very important after administering these doses This drug should be administered under the supervision of an experienced cancer chemotherapy physician Prior treatment with other myelosuppressive drugs, patients predisposed to seizures. May cause secondary malignancies (tumors, acute leukaemias, ovarian failure). Previous irradiation/therapy. Discontinue if lung toxicity develops. Bone marrow depression may occur Seizures reported with use; initiate anticonvulsant prophylactic therapy prior to treatment with busulfan; monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs Cardiac temponade reported in children with thalassemia in combination with cyclophosphamide Ovarian failure may occur Secondary malignancies reported Antiemetics may be recommended to prevent nausea and vomiting Increased risk of developing hepatic veno-occlusive disease (HVOD) at AUC greater than 1,500 μM•min; monitor serum transaminases, alkaline phosphatase and bilirubin daily Bronchopulmonary dysplasia with pulmonary fibrosis reported and can be fatal; toxicity may be additive if used with other agents that cause pulmonary toxicity; discontinue therapy if busulfan toxicity develops Monitor: CBC, Hgb, LFTs

Pregnancy-Lactation

Pregnancy Can cause fetal harm when administered to a pregnant woman based on animal data; drug shown to be teratogenic in mice, rats, and rabbits following administration during organogenesis; the solvent, DMA, may also cause fetal harm when administered to a pregnant woman; in rats, DMA doses of approximately 40% of daily dose of DMA in dose on a mg/m² basis given during organogenesis caused significant developmental anomalies; there are no available human data informing drug-associated risk; advise pregnant women of potential risk to a fetus Advise females of reproductive potential to use effective contraception during treatment and for 6 months following cessation of therapy May damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; males with female sexual partners of reproductive potential should use effective contraception during treatment and for 3 months after cessation of therapy Infertility Females: Ovarian suppression and amenorrhea commonly occur in premenopausal women undergoing chronic, low-dose busulfan therapy for chronic myelogenous leukemia; therapy may also cause temporary or permanent infertility in prepubertal girls or in females of child-bearing potential treated with high-dose busulfan in the conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation Males: Sterility, azoospermia, and testicular atrophy reported in male patients

Interactions

Decreased clearance when used with cyclophosphamide and itraconazole. Increased clearance by phenytoin. May reduce response to vaccines, possibility of generalized infections with live vaccines. Combination with thioguanine results in oesophageal varices and abdominal liver function tests. Potentially Fatal: Cytotoxic agents may increase risk of pulmonary toxicity. Serious (21) adenovirus types 4 and 7 live, oral apalutamide axicabtagene ciloleucel brexucabtagene autoleucel ciltacabtagene autoleucel didanosine etrasimod fexinidazole idecabtagene vicleucel idelalisib influenza virus vaccine quadrivalent, adjuvanted influenza virus vaccine trivalent, adjuvanted lisocabtagene maraleucel lonafarnib palifermin pexidartinib pretomanid ropeginterferon alfa 2b tisagenlecleucel tofacitinib tucatinib

Adverse Effects

Side effects of Busulphan : >10% Neutropenia (nearly 100%) Myelosuppression (nearly 100%) Thrombocytopenia (98%) Nausea (97%) Stomatitis (96%) Anorexia (80%) Diarrhea (80%) Fever (80%) Insomnia (80%) Lymphopenia (79%) Hypomagnesemia (77%) Headache (69%) Hyperglycemia (66%) Hypokalemia (64%) Abdominal pain (62%) Anemia (62%) Asthenia (52%) Hypocalcemia (49%) Chills (47%) Dyspepsia (44%) Tachycardia (44%) Pain (41%) Constipation (38%) Hypertension (36%) Hypersensitivity (32%) Edema (27%) Thrombosis (27%) Dry mouth (26%) Vasodilation (25%) Mild epistaxis (25%) Inflammation at injection site (25%) Rectal disorder (25%) Abdominal enlargement (23%) Back pain (23%) Chest pain (22%) 1-10% Grade 3/4 Hypertension (7%, IV) Hypotension (3%, IV) Cardiac tamponade (2%, oral) Third degree AV block (2%, IV) Left heart failure (2%, IV) Frequency Not Defined Dizziness Anxiety Depression Seizure Cough Dyspnea Rhinitis Bronchopulmonary dysplasia with pulmonary fibrosis (rare) Aplastic anemia (rare) Leukemia (rare) Graft versus host disease Adrenal gland disorder Pruritis Rash Cataract Hemorrhagic cystitis Amenorrhea Male infertility Ovarian dysfunction Potentially Fatal: Bone marrow depression manifesting as thrombocytopaenia, leucopaenia, anaemia. Interstitial pulmonary fibrosis (known as "busulfan lung" on prolonged treatment).

Mechanism of Action

Busulfan reacts with N-7 position of guanosine and interferes with DNA replication and RNA transcription by alkylating and cross-linking the DNA strands.

Note

Myleran 2mg Tablet manufactured by Excella, Germany. Its generic name is Busulphan. Myleran is availble in Bangladesh. Farmaco BD drug index information on Myleran Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.