Clofarabine
Generic Name: clofarabine
Brand Names:
Clofarabine
11 DESCRIPTION Clofarabine injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C 10 H 11 ClFN 5 O 3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is: Clofarabine injection (1 mg/mL) is supplied in a 20 mL, single-dose vial.
Overview
11 DESCRIPTION Clofarabine injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C 10 H 11 ClFN 5 O 3 with a molecular weight of 303.68 Daltons. The molecular structure of clofarabine is: Clofarabine injection (1 mg/mL) is supplied in a 20 mL, single-dose vial.
Uses
1 INDICATIONS AND USAGE Clofarabine injection 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. Clofarabine injection is a nucleoside metabolic inhibitor 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. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administer the recommended pediatric dose of 52 mg/m 2 as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28-day cycle. Repeat cycles every 2 to 6 weeks. (2.1) Provide supportive care, such as intravenous infusion fluids, antihyperuricemic treatment and alkalinization of urine throughout the 5 days of clofarabine injection administration to reduce the risk of tumor lysis and other adverse reactions. ( 2.1) Discontinue clofarabine injection if hypotension develops during the 5 days of administration. (2.1) Reduce the dose in patients with renal impairment. ( 2.2 ) Use dose modification for toxicity.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Hemorrhage [see Warnings and Precautions ( 5.2 )] • Serious Infections [see Warnings and Precautions ( 5.3 )] • Hyperuricemia (tumor lysis syndrome) [see Warnings and Precautions ( 5.4 )] • Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome [see Warnings and Precautions ( 5.5 )] • Venous Occlusive Disease of the Liver [see Warnings and Precautions ( 5.6 )] • Hepatotoxicity [see Warnings and Precautions ( 5.7 )] • Renal Toxicity [see Warnings and Precautions ( 5.8 )] • Enterocolitis [see Warnings and Precautions ( 5.9 )] • Skin Reactions [see Warnings and Precautions ( 5....
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during clofarabine injection therapy. ( 5.1 ) Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. ( 5.2 ) Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue clofarabine injection and treat promptly. ( 5.3 ) Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. ( 5.4 ) Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue clofarabine injection immediately if suspected. 4 CONTRAINDICATIONS None. • None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary In animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m 2 based on body surface area (BSA) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see Data). Advise pregnant women of the potential risk to a fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Clofarabine injection is supplied in single-dose flint vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 43598-309-20). The 20 mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.
Frequently Asked Questions
What is Clofarabine used for?▼
1 INDICATIONS AND USAGE Clofarabine injection 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. Clofarabine injection is a nucleoside metabolic inhibitor 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. ( 1 )
What are the side effects of Clofarabine?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Hemorrhage [see Warnings and Precautions ( 5.2 )] • Serious Infections [see Warnings and Precautions ( 5.3 )] • Hyperuricemia (tumor lysis syndrome) [see Warnings and Precautions ( 5.4 )] • Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome [see Warnings and Precautions ( 5.5 )] • Venous Occlusive Disease of the Liver [see Warnings and Precautions ( 5.6 )] • Hepatotoxicity [see Warnings and Precautions ( 5.7 )] • Renal Toxicity [see Warnings and Precautions ( 5.8 )] • Enterocolitis [see Warnings and Precautions ( 5.9 )] • Skin Reactions [see Warnings and Precautions ( 5....
Can I take Clofarabine during pregnancy?▼
8.1 Pregnancy Risk Summary In animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m 2 based on body surface area (BSA) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see Data). Advise pregnant women of the potential risk to a fetus.
What are the important warnings for Clofarabine?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during clofarabine injection therapy. ( 5.1 ) Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. ( 5.2 ) Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue clofarabine injection and treat promptly. ( 5.3 ) Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. ( 5.4 ) Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue clofarabine injection immediately if suspected. 4 CONTRAINDICATIONS None. • None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.