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CLOLAR is a brand name for Clofarabine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CLOLAR® (clofarabine) 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. Approval is based on objective response rates. No survival advantage has…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Recommended Concomitant Medications Provide IV infusion fluids throughout the 5 days of CLOLAR administration to reduce the effects of tumor lysis and other adverse events. Consider prophylactic anti-emetic medications as CLOLAR is moderately emetogenic.
, hypotension, tachycardia, tachypnea, and pulmonary edema). The administration of alkalinized intravenous fluids, allopurinol and/or other uric acid-lowering agents may be considered prior to clofarabine administration to prevent tumor lysis syndrome.
Institutional guidelines should be followed in regards to the dosing and schedule of administration of these agents. 2 Recommended Dose and Dosage Adjustment Dosing Schedule and Administration The pediatric (ages 1-21) dose of 52 mg/m2 of body surface area is administered by intravenous infusion over 2 hours daily for 5 consecutive days.
o Longer infusion times should be considered in children weighing < 20 kg (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics) Treatment cycle comprises a 5-day course of CLOLAR followed by the recovery period of 2 to 6 weeks (median 4 weeks) from the starting day of the previous cycle.
The cycles are repeated following recovery or return to baseline organ function. In clinical trials in pediatric acute leukemias, the median duration of a cycle was 28 days (range of 12-55 days) (see 14 CLINICAL TRIALS). The majority of patients who respond to CLOLAR achieve a response after 1 or 2 treatment cycles (see 14 CLINICAL TRIALS).
Therefore the potential benefit and risks associated with continued therapy in patients who do not show hematological or clinical improvement after 2 treatment cycles should be assessed by treating physicians. Close monitoring of fluid status, and renal and hepatic function during the 5 days of CLOLAR administration is advised (see 7 WARNINGS AND PRECAUTIONS).
CLOLAR should not be administered in patients with severe hepatic impairment or severe renal insufficiency (see 2 CONTRAINDICATIONS). Close monitoring of patients taking medications known to affect blood pressure or cardiac function during administration of CLOLAR is advised.
75 x 109/L. 5 x 109/L) lasting ≥ 4 weeks, reduce dose by 25% for the next cycle. Non-hematologic Toxicity Withhold CLOLAR if a patient develops a clinically significant infection, until the infection is clinically resolved and then restart at the full dose.
). Severe hepatic impairment (defined as elevated transaminases (AST and/or ALT) > 5 x ULN, and/or elevated bilirubin > 3 x ULN) or severe renal insufficiency (defined as creatinine clearance < 30 mL/min). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions CLOLAR (clofarabine) must be administered under the supervision of a physician qualified in the use of antineoplastic agents.
1 Dosing Considerations Recommended Concomitant Medications Provide IV infusion fluids throughout the 5 days of CLOLAR administration to reduce the effects of tumor lysis and other adverse events. Consider prophylactic anti-emetic medications as CLOLAR is moderately emetogenic.
, hypotension, tachycardia, tachypnea, and pulmonary edema). The administration of alkalinized intravenous fluids, allopurinol and/or other uric acid-lowering agents may be considered prior to clofarabine administration to prevent tumor lysis syndrome.
Institutional guidelines should be followed in regards to the dosing and schedule of administration of these agents. 2 Recommended Dose and Dosage Adjustment Dosing Schedule and Administration The pediatric (ages 1-21) dose of 52 mg/m2 of body surface area is administered by intravenous infusion over 2 hours daily for 5 consecutive days.
o Longer infusion times should be considered in children weighing < 20 kg (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics) Treatment cycle comprises a 5-day course of CLOLAR followed by the recovery period of 2 to 6 weeks (median 4 weeks) from the starting day of the previous cycle.
The cycles are repeated following recovery or return to baseline organ function. In clinical trials in pediatric acute leukemias, the median duration of a cycle was 28 days (range of 12-55 days) (see 14 CLINICAL TRIALS). The majority of patients who respond to CLOLAR achieve a response after 1 or 2 treatment cycles (see 14 CLINICAL TRIALS).
). CLOLAR should not be administered in patients with severe hepatic impairment or severe renal insufficiency (see 2 CONTRAINDICATIONS). Close monitoring of patients taking medications known to affect blood pressure or cardiac function during administration of CLOLAR is advised.
75 x 109/L. 5 x 109/L) lasting ≥ 4 weeks, reduce dose by 25% for the next cycle. Non-hematologic Toxicity Withhold CLOLAR if a patient develops a clinically significant infection, until the infection is clinically resolved and then restart at the full dose.
Withhold CLOLAR if a Grade 3 non-infectious non-hematologic toxicity (excluding nausea/vomiting that was controlled by antiemetic therapy) occurs. Re-institute CLOLAR administration at a 25% dose reduction when resolution or return to baseline.
Discontinue CLOLAR administration if ≥ Grade 3 liver enzyme elevations occurs. Discontinue CLOLAR administration if a Grade 4 non-infectious non-hematologic toxicity occurs. , hypotension, tachycardia, tachypnea, and pulmonary edema) and provide appropriate supportive measures.
Re-institute CLOLAR when the patient is stable, generally with a 25% dose reduction. CLOLAR administration should be stopped if the patient develops hypotension for any reason during the 5 days of administration. If hypotension is transient and resolves without pharmacological intervention, CLOLAR treatment can be re-instituted generally with a 25% dose reduction.
Withhold CLOLAR administration if a substantial increase in creatinine is noted. Re- institute CLOLAR when the patient is stable and organ function has returned to baseline, possibly with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), prophylactically administer allopurinol or other uric acid lowering medications.
Institutional guidelines should be followed in regards to the dosing and schedule of administration of these agents. Use in patients with hepatic and renal dysfunction: CLOLAR has not been studied in patients with renal or hepatic dysfunction.
Hypersensitivity to clofarabine or any of the excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Symptomatic central nervous system involvement (see 14 CLINICAL TRIALS) History of serious heart, liver, kidney or pancreas disease (see 8 ADVERSE REACTIONS).
Severe hepatic impairment (defined as elevated transaminases (AST and/or ALT) > 5 x ULN, and/or elevated bilirubin > 3 x ULN) or severe renal insufficiency (defined as creatinine clearance < 30 mL/min).
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Withhold CLOLAR if a Grade 3 non-infectious non-hematologic toxicity (excluding nausea/vomiting that was controlled by antiemetic therapy) occurs. Re-institute CLOLAR administration at a 25% dose reduction when resolution or return to baseline.
Discontinue CLOLAR administration if ≥ Grade 3 liver enzyme elevations occurs. Discontinue CLOLAR administration if a Grade 4 non-infectious non-hematologic toxicity occurs. , hypotension, tachycardia, tachypnea, and pulmonary edema) and provide appropriate supportive measures.
Re-institute CLOLAR when the patient is stable, generally with a 25% dose reduction. CLOLAR administration should be stopped if the patient develops hypotension for any reason during the 5 days of administration. If hypotension is transient and resolves without pharmacological intervention, CLOLAR treatment can be re-instituted generally with a 25% dose reduction.
Withhold CLOLAR administration if a substantial increase in creatinine is noted. Re- institute CLOLAR when the patient is stable and organ function has returned to baseline, possibly with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), prophylactically administer allopurinol or other uric acid lowering medications.
Institutional guidelines should be followed in regards to the dosing and schedule of administration of these agents. Use in patients with hepatic and renal dysfunction: CLOLAR has not been studied in patients with renal or hepatic dysfunction.
Its use in such patients should be undertaken only with the greatest caution. Renal Impairment Reduce the dose by 50% in patients with creatinine clearance (CrCL) between 30 and 60 mL/min. 4 mg/mL. Use diluted preparation immediately.
Do not administer any other medications through the same intravenous line. As with all parenteral drug products, CLOLAR injection and diluted IV infusion should be inspected visually for clarity, haziness, particulate matter or precipitate and leakage prior to administration.
Solution showing discoloration, haziness, precipitate, particulate, or leakage should not be used. Discard unused portion.
Therefore the potential benefit and risks associated with continued therapy in patients who do not show hematological or clinical improvement after 2 treatment cycles should be assessed by treating physicians. Close monitoring of fluid status, and renal and hepatic function during the 5 days of CLOLAR administration is advised (see 7 WARNINGS AND PRECAUTIONS).
CLOLAR should not be administered in patients with severe hepatic impairment or severe renal insufficiency (see 2 CONTRAINDICATIONS). Close monitoring of patients taking medications known to affect blood pressure or cardiac function during administration of CLOLAR is advised.
75 x 109/L. 5 x 109/L) lasting ≥ 4 weeks, reduce dose by 25% for the next cycle. Non-hematologic Toxicity Withhold CLOLAR if a patient develops a clinically significant infection, until the infection is clinically resolved and then restart at the full dose.
Withhold CLOLAR if a Grade 3 non-infectious non-hematologic toxicity (excluding nausea/vomiting that was controlled by antiemetic therapy) occurs. Re-institute CLOLAR administration at a 25% dose reduction when resolution or return to baseline.
Discontinue CLOLAR administration if ≥ Grade 3 liver enzyme elevations occurs. Discontinue CLOLAR administration if a Grade 4 non-infectious non-hematologic toxicity occurs. , hypotension, tachycardia, tachypnea, and pulmonary edema) and provide appropriate supportive measures.
Re-institute CLOLAR when the patient is stable, generally with a 25% dose reduction. CLOLAR administration should be stopped if the patient develops hypotension for any reason during the 5 days of administration. If hypotension is transient and resolves without pharmacological intervention, CLOLAR treatment can be re-instituted generally with a 25% dose reduction.
Withhold CLOLAR administration if a substantial increase in creatinine is noted. Re- institute CLOLAR when the patient is stable and organ function has returned to baseline, possibly with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), prophylactically administer allopurinol or other uric acid lowering medications.
Institutional guidelines should be followed in regards to the dosing and schedule of administration of these agents. Use in patients with hepatic and renal dysfunction: CLOLAR has not been studied in patients with renal or hepatic dysfunction.
Its use in such patients should be undertaken only with the greatest caution. Renal […]
Its use in such patients should be undertaken only with the greatest caution. Renal Impairment Reduce the dose by 50% in patients with creatinine clearance (CrCL) between 30 and 60 mL/min. 4 mg/mL. Use diluted preparation immediately.
Do not administer any other medications through the same intravenous line. As with all parenteral drug products, CLOLAR injection and diluted IV infusion should be inspected visually for clarity, haziness, particulate matter or precipitate and leakage prior to administration.
Solution showing discoloration, haziness, precipitate, particulate, or leakage should not be used. Discard unused portion. 5 OVERDOSAGE There were no known overdoses of CLOLAR. The highest daily dose administered to a human to date (on a mg/m2 basis) has been 70 mg/m2/day x 5 days (2 pediatric ALL patients).
The toxicities in these 2 patients included grade 4 hyperbilirubinemia, grade 2 and 3 vomiting, and grade 3 maculopapular rash. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Description CLOLAR injection (1 mg/mL) is supplied in a 20 mL, single-use vial.
The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). Available single-pack and four-pack cartons. Not all package sizes may be marketed.
7 WARNINGS AND PRECAUTIONS General CLOLAR should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Dehydration/Hypotension As with other chemotherapeutic agents, patients receiving CLOLAR may experience vomiting and diarrhea; they should therefore be advised regarding appropriate measures to avoid dehydration.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, lightheadedness, fainting spells, or decreased urine output. CLOLAR administration should be stopped if the patient develops hypotension for any reason during the 5 days of administration.
If hypotension is transient and resolves without pharmacological intervention, CLOLAR treatment can be re-instituted Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Injection/ 1 mg/mL unbuffered normal saline (water for injection, USP, and sodium chloride, USP) CLOLAR (clofarabine for injection) Page 8 of 42 with a dose reduction (see 4 DOSAGE AND ADMINISTRATION).
, tachypnea, tachycardia, hypotension, pulmonary edema) that could progress to systemic inflammatory response syndrome (SIRS), capillary leak syndrome and multi-organ dysfunction. Discontinue CLOLAR immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome, either of which can be fatal, and consider use […]