Clolar Generic Name & Formulations
Clofarabine 1mg/mL; soln for IV infusion after dilution; preservative-free.
Purine nucleoside antimetabolite.
Single-dose vial (20mL)—1
Acute lymphoblastic leukemia (ALL) in patients 1–21 years of age after relapses from, and/or refractoriness to, at least two prior regimens.
Clolar Dosage and Administration
Monitor blood pressure, cardiac, renal, and hepatic function before and during therapy. Give by IV infusion over 2 hours. 1–21yrs: 52mg/m2 daily for 5 consecutive days; repeat approximately every 2–6 weeks following recovery or return to baseline organ function. Provide supportive care (eg, IV fluids, antihyperuricemics, alkalinize urine, steroids, antiemetics, diuretics, albumin) throughout treatment. Renal impairment (CrCl 30–60mL/min): reduce dose by 50%. Dose modifications: see full labeling.
Clolar Boxed Warnings
Obtain CBCs, platelets, and coagulation parameters during the 5 days of therapy. Discontinue if hypotension develops during administration. Monitor for signs/symptoms of infection; discontinue and treat if occurs. Monitor for tumor lysis syndrome, cytokine release (eg, tachypnea, hypotension); if cytokine release progresses to systemic inflammatory response syndrome (SIRS)/capillary leak syndrome and/or if organ dysfunction occurs, discontinue and treat; may restart at lower dose if organ function recovers and patient is stable. Monitor for venous occlusive disease of the liver in patients who previously received hematopoietic stem cell transplant; discontinue if suspected. Monitor hepatic function; discontinue immediately if Grade ≥3 liver enzyme and/or bilirubin elevation occurs. Monitor for renal toxicity; interrupt or discontinue if Grade ≥3 creatinine elevation occurs. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥6 months (females) and ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Minimize exposure to drugs with known renal toxicity during treatment. Consider avoiding concomitant drugs known to induce hepatic toxicity. Caution with drugs that affect BP or cardiac function; monitor.
Clolar Adverse Reactions
Vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, extremity pain, hypotension, epistaxis, petechiae; bone marrow suppression, infections, hyperuricemia, SIRS/capillary leak syndrome, hemorrhage (may be fatal), enterocolitis (monitor), serious skin reactions (discontinue for exfoliative or bullous rash or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected), hepatotoxicity (may be fatal), acute renal failure.
Clolar Clinical Trials
Clolar Patient Counseling