Busulfan (Busulfan)

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Trade Name: Busulfan

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 6 mg/mL

Storage and handling

BUSULFAN Alkylating Activity [MoA],Alkylating Drug [EPC]

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These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Busulfan injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression n
WARNING: MYELOSUPPRESSION
Arrayn- See full prescribing information for complete boxed warning.

Causes severe and prolonged myelosuppression. n
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Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Busulfan injection is an alkylating drug indicated for:

Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML). u00a0

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Pre-medicate with anticonvulsants (e.g., benzodiazepines, phenytoin, valproic acid or levetiracetam) and antiemetic. (, ) nn
Dilute and administer as intravenous infusion. Do not administer as intravenous push or bolus. (, ) nn
Recommended adult dose: 0.8 mg per kg of ideal body weight or actual body weight, whichever is lower, administered intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses. ()

Injection: 60 mg/10 mL (6 mg/mL) as a clear, colorless, sterile, solution in a single-dose vial for .

Injection: 60 mg/10 mL (6 mg/mL) single-dose vial.u00a0

u00a0Busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components.

u00a0Busulfan injection is contraindicated in patients with a history of hypersensitivity to any of its components. u00a0

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Seizures: Initiate anticonvulsant prophylactic therapy prior to treatment with busulfan. Monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs. u00a0 nn
Hepatic Veno-Occlusive Disease (HVOD): Increased risk of developing HVOD at AUC greater than 1,500 u03bcMu2022min. Monitor serum transaminases, alkaline phosphatase and bilirubin daily. u00a0 nn
Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (, , ) nn
Cardiac tamponade has been reported in pediatric patients with thalassemia who received high doses of oral busulfan and cyclophosphamide. Abdominal pain and vomiting preceded the tamponade in most patients. ()

u00a0The following adverse reactions are discussed in more detail in other sections of the labeling:
Most common adverse reactions (incidence > 60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia. u00a0
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. ()
Drugs that Increase Busulfan Clearance: Phenytoin. ()

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Lactation: Advise women not to breastfeed. ()

u00a0There is no known antidote to busulfan other than hematopoietic progenitor cell transplantation. In the absence of hematopoietic progenitor cell transplantation, the recommended dosage for busulfan would constitute an overdose of busulfan. The principal toxic effect is profound bone marrow hypoplasia/aplasia and pancytopenia, but the central nervous system, liver, lungs, and gastrointestinal tract may be affected. Monitor hematologic status closely and institute vigorous supportive measures as medically indicated. Survival after a single 140 mg dose of Myleran Tablets in an 18 kg, 4-year old child has been reported. Inadvertent administration of a greater than normal dose of oral busulfan (2.1 mg per kg; total dose of 23.3 mg per kg) occurred in a 2-year old child prior to a scheduled bone marrow transplant without sequelae. An acute dose of 2.4 g was fatal in a 10-year old boy. There is one report that busulfan is dialyzable, thus dialysis should be considered in the case of overdose.

Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CHSOO(CH)OSOCH with a molecular weight of 246.30 g/mole. Busulfan, USP has the following chemical structure:
Busulfan injection is supplied as a clear, colorless, sterile, solution in 10 mL single-dose vials for intravenous administration upon dilution. Each vial contains 60 mg of busulfan in N,N-dimethylacetamide (DMA), 3.3 mL and Polyethylene Glycol 400, 6.7 mL. The solubility of busulfan, USP in water is very slightly soluble in water and the pH of busulfan injection diluted to approximately 0.5 mg per mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9.

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Busulfan is a mutagen and a clastogen. In tests it caused mutations in and . Chromosomal aberrations induced by busulfan have been reported (rats, mice, hamsters, and humans) and (rodent and human cells). The intravenous administration of busulfan (48 mg/kg given as biweekly doses of 12 mg/kg, or 30% of the total busulfan dose on a mg/mbasis) has been shown to increase the incidence of thymic and ovarian tumors in mice.
Busulfan depleted oocytes of female rats and induced sterility in male rats and hamsters. The solvent DMA may also impair fertility. A DMA daily dose of 0.45 g/kg/day given to rats for nine days (equivalent to 44% of the daily dose of DMA contained in the recommended dose of busulfan on a mg/mbasis) significantly decreased spermatogenesis in rats. A single subcutaneous dose of 2.2 g/kg (27% of the total DMA dose contained in busulfan on a mg/mbasis) four days after insemination terminated pregnancy in 100% of tested hamsters n

Documentation of the safety and efficacy of busulfan as a component of a conditioning regimen prior to allogeneic hematopoietic progenitor cell reconstitution is derived from two sources:
i) analysis of a prospective clinical trial of busulfan that involved 61 patients diagnosed with various hematologic malignancies, and
ii) the published reports of randomized, controlled trials that employed high-dose oral busulfan as a component of a conditioning regimen for transplantation, which were identified in a literature review of five established commercial databases.
Prospective Clinical Trial of n- Busulfan:
Patients received 16 busulfan doses of 0.8 mg per kg every 6 hours as a two-hour infusion for 4 days, followed by cyclophosphamide 60 mg per kg once per day for two days (BuCy2 regimen). All patients received 100% of their scheduled busulfan regimen. No dose adjustments were made. After one rest day, allogeneic hematopoietic progenitor cells were infused. The efficacy parameters in this study were myeloablation (defined as one or more of the following: absolute neutrophil count [ANC] less than 0.5x10/L, absolute lymphocyte count [ALC] less than 0.1x10/L, thrombocytopenia defined as a platelet count less than 20,000/mmor a platelet transfusion requirement) and engraftment (ANC greater than or equal to 0.5x10/L).
All patients (61/61) experienced myeloablation. The median time to neutropenia was 4 days. All evaluable patients (60/60) engrafted at a median of 13 days post-transplant (range 9 to 29 days); one patient was considered non-evaluable because he died of a fungal pneumonia 20 days after BMT and before engraftment occurred. All but 13 of the patients were treated with prophylactic G-CSF. Evidence of donor cell engraftment and chimerism was documented in all patients who had a chromosomal sex marker or leukemic marker (43/43), and no patient with chimeric evidence of allogeneic engraftment suffered a later loss of the allogeneic graft. There were no reports of graft failure in the overall study population. The median number of platelet transfusions per patient was 6, and the median number of red blood cell transfusions per patient was 4.
Twenty-three patients (38%) relapsed at a median of 183 days post-transplant (range 36 to 406 days). Sixty-two percent of patients (38/61) were free from disease with a median follow-up of 269 days post-transplant (range 20 to 583 days). Forty-three patients (70%) were alive with a median follow up of 288 days post-transplant (range 51 to 583 days). There were two deaths before BMT Day +28 and six additional patients died by BMT Day +100. Ten patients (16%) died after BMT Day +100, at a median of 199 days post-transplant (range 113 to 275 days).
Oral Busulfan Literature Review:
Table 4 summarizes the efficacy analyses reported from these 4 studies.
Table 4: Summary of efficacy analyses from the randomized, controlled trials utilizing a high dose oral busulfan-containing conditioning regimen identified in a literature review.

1. OSHA Hazardous Drugs. OSHA. [Accessed on June 18, 2014 from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

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Myelosuppression
Advise patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if fever develops .
Seizures
Advise patients of the possibility of seizures and that they will be given medication to prevent them. Patients should be asked to report a history of seizure or head trauma n
Hepatic Veno-Occlusive Disease (HVOD)
Advise patients of the risks associated with the use of busulfan as well as the plan for regular blood monitoring during therapy. Specifically inform patients of the following: The risk of veno-occlusive liver disease n n
Embryo-fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy andn
Females of Reproductive Potential
Advise females of reproductive potential to use effective contraception during treatment with busulfan and for 6 months following cessation of therapy .
Males of Reproductive Potential
Advise males with female sexual partners of reproductive potential to use effective contraception during treatment with busulfan and for 3 months following cessation of therapy see n
Lactation
Advise females to discontinue breastfeeding during treatment with busulfan n
Infertility
Advise females and males of reproductive potential that busulfan may cause temporary or permanent infertility n n n
Cardiac Tamponade
Advise patients of the risk of cardiac tamponade. Instruct patients to report to their healthcare provider symptoms of abdominal pain and vomiting .
Bronchopulmonary Dysplasia
Advise patients of the possibility of bronchopulmonary dysplasia with pulmonary fibrosis with chronic busulfan therapy. Instruct patients to report symptoms of shortness of breath and cough to their healthcare provider. These symptoms could occur several months or years after therapy with busulfan.
All Trademarks listed are the property of their respective owners.
Manufactured by:n Telangana 509301, INDIA
Distributed by:n n Bridgewater, NJ 08807
Rev. 09-2020-03

NDC 70121-1244-1
Strength: n- 60 mg/10 mL (6 mg/mL)
R only
Vial Label
Amneal Pharmaceuticalsu00a0LLC
u00a0
NDC 70121-1244-7
Strength: n- 60 mg/10 mL (6 mg/mL)
R only
Carton Labeln
Amneal Pharmaceuticalsu00a0LLC

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Busulfan (Busulfan) which is also known as Busulfan and Manufactured by Amneal Biosciences LLC. It is available in strength of 6 mg/mL.

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