Clofarabine
Purine Analogues
Sold as Evoltra · Ivozall · CLOLAR
- Drug class
- Purine Analogues
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 4
- Products on record
- 7
- FDA reports (12 mo)
- 77
Overview
Plain-language summary, compiled from the cited regulatory records
Clofarabine is a medication classified as a purine analogue [1]. It functions as a nucleoside metabolic inhibitor [1].
Clofarabine injection is approved for treating pediatric patients aged 1 to 21 years who have relapsed or refractory acute lymphoblastic leukemia [1]. This indication applies after patients have undergone at least two prior treatment regimens [1].
In the past 12 months, there have been 77 adverse event reports associated with clofarabine [2]. The most frequently reported adverse events include off-label use, cytomegalovirus infection reactivation, drug ineffectiveness, multiple organ dysfunction syndrome, and pyrexia [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 3 | February 27, 2024 |
| GB United Kingdom | MHRA | 2 | September 24, 2021 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| EU European Union | EMA | 1 | July 22, 2024 |
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
(1)
How to take
GBUnited Kingdom· MHRA
2 products
Uses
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
1).
How to take
CACanada· Health Canada
1 product
Uses
CLOLAR® (clofarabine) is indicated for: the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses.
Approval is based on objective response rates. No survival advantage has been demonstrated and palliative benefit was not evaluated. 1 Pediatrics Pediatrics (1 to 21 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of CLOLAR in pediatric patients has been established.
Therefore, Health Canada has authorized an indication for pediatric use (see 1 INDICATIONS). 2 Adults and Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for adult and geriatric use.
EUEuropean Union· EMA
1 product
Uses
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
1).
How to take
Drug interactions
Known interactions involving Clofarabine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 405. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0a273a2d-a1ff-41… · revised August 23, 2022 [PDF]
- [2]MHRA (UK) · PL140480253 · revised August 2, 2019
- [3]Health Canada (DPD) · 02330407 · revised March 22, 2025
- [4]European Medicines Agency · EMEA/H/C/000613 · revised July 22, 2024
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.