Clolar

Relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients 1 to 21 years of age, after at least two prior regimens.

52 mg/m² IV over 2 hours daily for 5 consecutive days
Repeated every 2-6 weeks following recovery of hematologic counts
Premedication: Prophylactic steroids (e.g., hydrocortisone 100 mg/m² on Days 1-3) to mitigate SIRS/capillary leak
Hydration: Continuous IV fluids throughout treatment days to reduce tumor lysis and maintain renal perfusion

Injection: 1 mg/mL (20 mg/20 mL) in single-dose vial

None listed.

• Myelosuppression: Severe and prolonged. Febrile neutropenia in 57%. Recovery may take 2-6 weeks.
• Systemic Inflammatory Response Syndrome (SIRS) / Capillary Leak Syndrome: Signs include tachypnea, tachycardia, hypotension, pulmonary edema. Can be fatal. D/C immediately if suspected. Give prophylactic steroids.
• Tumor Lysis Syndrome: Monitor and provide aggressive hydration. May require dialysis.
• Hepatotoxicity: Including hepatic VOD/SOS, which has been fatal. Monitor LFTs frequently. D/C if significant hepatotoxicity.
• Nephrotoxicity: Elevations in creatinine reported. Maintain hydration.
• Enterocolitis: Including neutropenic colitis, cecitis, and C. difficile colitis.

Vomiting (83%), nausea (75%), febrile neutropenia (57%), diarrhea (56%), pruritus (47%), headache (46%), pyrexia (41%), dermatitis (41%), rigors (38%), abdominal pain (36%), fatigue (36%), tachycardia (35%), epistaxis (31%), anorexia (30%), petechiae (29%), hepatomegaly (25%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Clofarabine is a purine nucleoside antimetabolite. It is phosphorylated intracellularly to the active triphosphate (clofarabine-5'-triphosphate), which inhibits DNA polymerases and ribonucleotide reductase. Inhibition of ribonucleotide reductase depletes deoxyribonucleotide pools needed for DNA synthesis. Incorporation into DNA causes chain termination and induces apoptosis. The 2'-fluoro and 2'-chloro substitutions provide resistance to deamination by adenosine deaminase and phosphorolysis by purine nucleoside phosphorylase.

Half-life: approximately 5.2 hours. Vd: 172 L/m². Protein binding: 47%. Not appreciably metabolized; 49-60% excreted unchanged in urine. CrCl-dependent clearance.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• CLO-212 — Clofarabine in pediatric relapsed/refractory ALL. Phase II, n=61.
  🔬 NCT00063596 ↗ 📄 Primary Publication ↗

Clolar has FDA-approved indications across the following cancer types covered on PipelineEvidence: