Clofarabine (Clolar)

General information

Class/mechanism: Purine analog, inhibits DNA synthesis and repair by inhibiting ribonucleotide reductase and competitively inhibiting DNA polymerases. It also causes apoptosis by disrupting the integrity of the mitochondrial membrane, triggering the release of cytochrome C and apoptosis-inducing factor, which are pro-apoptotic mitochondrial proteins.
Route: IV, PO
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Acute lymphoblastic leukemia
• Acute myeloid leukemia
• Myelodysplastic syndrome

Patient drug information

• Brief patient counseling information can be found at the bottom of page 2 of the package insert
• Clofarabine (Clolar) patient drug information (UpToDate)

History of changes in FDA indication

• 2004-12-28: Accelerated approval for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. (Based on Jeha et al. 2003 & CLO212)
  • 2022-07-18: Converted to regular approval

History of changes in EMA indication

• 2006-05-29: Initial authorization as Evoltra

History of changes in Health Canada indication

• 2009-07-16: Initial notice of compliance

History of changes in PMDA indication

• 2013-03-25: Initial approval for the treatment of recurrent or refractory acute lymphoblastic leukemia.

Also known as

• Generic name: klofarabin
• Brand names: Clolar, Evoltra, Evorabin, Ivozall