BUSULFAN INJECTION Highlights

(busulfan injection)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BUSULFAN INJECTION safely and effectively. See full prescribing information for BUSULFAN INJECTION.

BUSULFAN INJECTION, for intravenous use
Initial U.S. Approval: 1999

WARNING: MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

  • Causes severe and prolonged myelosuppression. (5.1)
  • Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. (5.1)

INDICATIONS AND USAGE

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). (1)

DOSAGE AND ADMINISTRATION

  • Pre-medicate with anticonvulsants (e.g. benzodiazepines, phenytoin, valproic acid or levetiracetam) and antiemetic. (2.1, 5.2)
  • Dilute and administer as intravenous infusion. Do not administer as intravenous push or bolus. (2.1, 2.3)
  • 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. (2.1)

DOSAGE FORMS AND STRENGTHS

  • Injection: 60 mg/10 mL (6 mg/mL) single-dose vial. (3)

CONTRAINDICATIONS

Busulfan Injection is contraindicated in patients with a history of hypersensitivity to any of its components. (4)

WARNINGS AND PRECAUTIONS

  • Seizures: Initiate anticonvulsant prophylactic therapy prior to treatment with Busulfan Injection. Monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs. (5.2)
  • Hepatic Veno-Occlusive Disease (HVOD): Increased risk of developing HVOD at AUC greater than 1,500 µM∙min. Monitor serum transaminases, alkaline phosphatase and bilirubin daily. (5.3)
  • Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.4, 8.1, 8.3)
  • 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. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Drugs that Decrease Busulfan Injection Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. (7.1)
  • Drugs that Increase Busulfan Injection Clearance: Phenytoin. (7.2)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BUSULFAN INJECTION safely and effectively. See full prescribing information for BUSULFAN INJECTION.

BUSULFAN INJECTION, for intravenous use
Initial U.S. Approval: 1999

WARNING: MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

  • Causes severe and prolonged myelosuppression. (5.1)
  • Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. (5.1)

INDICATIONS AND USAGE

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). (1)

DOSAGE AND ADMINISTRATION

  • Pre-medicate with anticonvulsants (e.g. benzodiazepines, phenytoin, valproic acid or levetiracetam) and antiemetic. (2.1, 5.2)
  • Dilute and administer as intravenous infusion. Do not administer as intravenous push or bolus. (2.1, 2.3)
  • 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. (2.1)

DOSAGE FORMS AND STRENGTHS

  • Injection: 60 mg/10 mL (6 mg/mL) single-dose vial. (3)

CONTRAINDICATIONS

Busulfan Injection is contraindicated in patients with a history of hypersensitivity to any of its components. (4)

WARNINGS AND PRECAUTIONS

  • Seizures: Initiate anticonvulsant prophylactic therapy prior to treatment with Busulfan Injection. Monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs. (5.2)
  • Hepatic Veno-Occlusive Disease (HVOD): Increased risk of developing HVOD at AUC greater than 1,500 µM∙min. Monitor serum transaminases, alkaline phosphatase and bilirubin daily. (5.3)
  • Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.4, 8.1, 8.3)
  • 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. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Drugs that Decrease Busulfan Injection Clearance: Metronidazole, itraconazole, iron chelating agents, acetaminophen. (7.1)
  • Drugs that Increase Busulfan Injection Clearance: Phenytoin. (7.2)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2020

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