Clolar 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. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
Warnings and Precautions:Clolar® should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
InfectionsThe use of Clolar is likely to increase the risk of infection, including severe sepsis, as a result of bone marrow suppression. Monitor patients for signs and symptoms of infection and treat promptly.
Hyperuricemia (Tumor Lysis)Administration of Clolar may result in a rapid reduction in peripheral leukemia cells. Evaluate and monitor patients undergoing treatment for signs and symptoms of tumor lysis syndrome. Provide intravenous infusion fluids throughout the five days of Clolar administration to reduce the effects of tumor lysis and other adverse events. Administer allopurinol if hyperuricemia (tumor lysis) is expected.
Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome
Hepatic EnzymesHepato-biliary enzyme elevations were frequently observed in pediatric patients during treatment with Clolar. Some patients discontinued treatment due to hepatic enzyme abnormalities.
Hepatic and Renal Impairment
Use in PregnancyClolar can cause fetal harm when administered to a pregnant woman. Intravenous doses of clofarabine in rats and rabbits administered during organogenesis caused an increase in resorptions, malformations, and variations. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Clolar.
Nursing MothersFemale patients should be advised to avoid breast-feeding during treatment with Clolar.
Incidence of Treatment Emergent Laboratory Abnormalities (All Grades)
|Parameter||Any grade||Grade 3 or higher|
|Elevated total bilirubin||45%||13%|
Adverse Reactions:Most common adverse reactions with Clolar were nausea (73%), vomiting (78%), diarrhea (56%), febrile neutropenia (55%), headache (43%), rash (38%), pruritus (43%), pyrexia (39%), fatigue (34%), palmar-plantar erythrodysesthesia syndrome (16%), anxiety (21%), flushing (19%), and mucosal inflammation (16%).