Clofarabine 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. MedsAcross supplies Clofarabine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Clofarabine is sequentially metabolized intracellularly to the 5’-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5’-triphosphate metabolite. Clofarabine has affinity for the activating phosphorylating enzyme, deoxycytidine kinase, equal to or greater than that of the natural substrate, deoxycytidine. Clofarabine inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through an inhibitory action on ribonucleotide reductase, and by terminating DNA chain elongation and inhibiting repair through incorporation into the DNA chain by competitive inhibition of DNA polymerases. The affinity of clofarabine triphosphate for these enzymes is similar to or greater than that of deoxyadenosine triphosphate.
Source: US FDA prescribing information
Administer the recommended pediatric dose of 52 mg/m 2 as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28-day cycle. Repeat cycles every 2 to 6 weeks. Provide supportive care, such as intravenous infusion fluids, antihyperuricemic treatment, and alkalinization of urine throughout the 5 days of clofarabine injection administration to reduce the risk of tumor lysis and other adverse reactions. Discontinue clofarabine injection if hypotension develops during the 5 days of administration. Reduce the dose in patients with renal impairment. Use dose modification for toxicity.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during clofarabine injection therapy. Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection, discontinue clofarabine injection and treat promptly. Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue clofarabine injection immediately if suspected. Venous Occlusive Disease of the Liver: Monitor for and discontinue clofarabine injection if suspected. Hepatotoxicity: Severe and fatal hepatotoxicity.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Myelosuppression Hemorrhage Serious Infections Hyperuricemia (tumor lysis syndrome) Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome Venous Occlusive Disease of the Liver Hepatotoxicity Renal Toxicity Enterocolitis Skin Reactions Most common adverse reactions ( > 25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae.
Source: US FDA prescribing information
Do not freeze. Vials containing undiluted clofarabine injection should be stored at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Clofarabine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Clofarabine 20 mg/20 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Clofarabine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Clofarabine and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Clofarabine on 28 December 2004, according to Drugs@FDA.
Yes. Clofarabine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Clofarabine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Clofarabine is classified under ATC code L01BB06 (Clofarabine).
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