#
Busulfan Concentrate Injection
  • Professionals
  • FDA PI

Busulfan Concentrate Injection

Dosage form: injection, solution, concentrate
Drug class:Alkylating agents

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

WARNING: MYELOSUPPRESSION

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[see Warnings and Precautions (5.1)].

Indications and Usage for Busulfan Concentrate Injection

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 Concentrate Injection Dosage and Administration

Initial Dosing Information

  • Administer busulfan injection in combination with cyclophosphamide as a conditioning regimen prior to bone marrow or peripheral blood progenitor cell replacement. For patients weighing more than 12 kg, the recommended doses are:
    • Busulfan 0.8 mg per kg (ideal body weight or actual body weight, whichever is lower) intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses (Days -7, -6, -5 and -4).
    • Cyclophosphamide 60 mg per kg intravenously as a one-hour infusion on each of two days beginning no sooner than six hours following the 16th dose of busulfan injection (Days -3 and -2).
    • Administer hematopoietic progenitor cells on Day 0.
  • Premedicate patients with anticonvulsants (e.g., benzodiazepines, phenytoin, valproic acid or levetiracetam) to prevent seizures reported with the use of high dose busulfan. Administer anticonvul..