Trade Names:Clolar- Solution for injection 1 mg/mL
Inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools by 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.
Plasma protein binding, predominantly to albumin, is 47%. Steady state Vd is 172 L/m 2 .
Systemic CL is 28.8 L/h/m 2 and the terminal t ½ is about 5.2 h. Based on the 24-h urine collection in pediatrics, 49% to 60% of the dose is excreted unchanged in the urine.
Treatment of patients 1 to 21 yr of age with relapsed or refractory acute lymphoblastic leukemia after at least 2 prior regimens.
IV Recommended dose is 52 mg/m 2 infused over 2 h/day for 5 days. Treatment cycles are repeated following recovery or return to baseline organ function, approximately every 2 to 6 wk.
Store unopened vials of solution for injection at controlled room temperature (59° to 86°F). Diluted infusion solution contains no preservative and must be administered within 24 h of preparation if stored at room temperature.
None well documented.
None well documented.
Pericardial effusion (35%); tachycardia (34%); hypotension (29%); left ventricular systolic dysfunction (27%); hypertension (11%).
Headache (46%); pyrexia (41%); fatigue (36%); anxiety (22%); dizziness (16%); depression, irritability (11%); somnolence, tremor (10%).
Pruritus (47%); dermatitis (41%); petechiae (29%); erythema, flushing (18%); palmar-plantar erythrodysethesia syndrome (13%); contusion (11%); dry skin (10%).
Vomiting (83%); nausea (75%); diarrhea (53%); abdominal pain (36%); anorexia (31%); constipation (21%); gingival bleeding (15%); sore throat (14%); oral candidiasis (13%); decreased appetite (11%).
Febrile neutropenia (57%); neutropenia, transfusion reaction (10%).
Hepatomegaly, jaundice (15%).
Elevated ALT (44%); elevated AST (38%); elevated bilirubin (15%); elevated creatinine (6%).
Injection site pain (14%).
Decreased weight (10%).
Rigors (38%); limb pain (29%); myalgia (14%); back pain (13%); arthralgia (11%).
Cough (19%); respiratory distress (14%); dyspnea (13%); pleural effusion, pneumonia (10%).
Edema (20%); pain (19%); mucosal inflammation (18%); sepsis (15%); staphylococcal infections (13%); cellulitis, herpes simplex (11%); bacteremia (10%).
Monitor BP frequently during the 5 days of clofarabine administration. Stop therapy if patient develops hypotension for any reason. If hypotension is transient and resolves without pharmacologic intervention, consider reinstituting therapy at a lower dose.CBC
Ensure CBC with differential and platelet count are evaluated before starting therapy and then at regular intervals during clofarabine. Notify health care provider of any significant cytopenia. Monitor blood and platelet counts more frequently if cytopenia develops.Hyperuricemia
Ensure risk of developing hyperuricemia is evaluated before starting therapy and that hypouricemic therapy, including adequate fluid intake and administration of allopurinol, and monitoring of uric acid, is initiated before starting treatment in patient determined to be at risk for developing hyperuricemia and urate precipitation.Renal/Hepatic function
Ensure renal and hepatic function are monitored closely during the 5 days of clofarabine administration. Discontinue therapy and notify health care provider if substantial increases in creatinine or bilirubin are noted. Consider reinstituting clofarabine at a lower dose when patient is stable and organ function has returned to normal.Tumor lysis syndrome/Cytokine release
Monitor patient closely for signs or symptoms of tumor lysis syndrome and cytokine release (eg, tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome, capillary leak, and organ dysfunction. Immediately discontinue infusion and inform health care provider if systemic inflammatory response syndrome or capillary leak syndrome noted or suspected. Be prepared to provide supportive measures (eg, corticosteroids, diuretics, albumin). Consider reinstituting clofarabine at a lower dose when patient is stable.WBC
Implement infection control measures if WBC drops; implement bleeding precautions if platelet count drops.
Category D .
Safety and efficacy not established.
Should be anticipated; anemia, neutropenia, and thrombocytopenia have been reported.
Ensure woman who is breastfeeding discontinues breastfeeding during treatment with clofarabine.
Because clofarabine primarily is excreted by the kidneys, avoid renal toxic drugs during the 5 days of clofarabine administration.
Patients may experience vomiting and diarrhea; therefore, appropriate measures should be taken to avoid dehydration.
Use with caution.
Vomiting, maculopapular rash, hyperbilirubinemia.
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