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Clofarabine
Overview
What is Clofarabine?
Clofarabine injection contains clofarabine, a purine nucleoside metabolic inhibitor. Clofarabine injection (1 mg/mL) is supplied in a 20 mL, single-dose 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). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.
What does Clofarabine look like?
What are the available doses of Clofarabine?
20 mg/20 mL (1 mg/mL) single-dose vial
What should I talk to my health care provider before I take Clofarabine?
How should I use Clofarabine?
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. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection.
Administer the recommended pediatric dose of 52 mg/m as an intravenous infusion over 2 hours daily for 5 consecutive days.
What interacts with Clofarabine?
Sorry No Records found
What are the warnings of Clofarabine?
Sorry No Records found
What are the precautions of Clofarabine?
Sorry No Records found
What are the side effects of Clofarabine?
Sorry No records found
What should I look out for while using Clofarabine?
None
What might happen if I take too much Clofarabine?
There were no known overdoses of clofarabine injection. The highest daily dose administered to a human to date (on a mg/m basis) has been 70 mg/m/day × 5 days (2 pediatric ALL patients). The toxicities included in these 2 patients included Grade 4 hyperbilirubinemia, Grade 2 and 3 vomiting, and Grade 3 maculopapular rash.
In a Phase 1 study of adults with refractory and/or relapsed hematologic malignancies, the recommended pediatric dose of 52 mg/m/day was not tolerated.
How should I store and handle Clofarabine?
Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Clofarabine injection is supplied in single-dose 20 mL clear tubular USP Type-I vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 60505-6166-0). The 20 mL tubular USP Type-I clear vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.Vials containing undiluted clofarabine injection should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.Procedures for proper handling and disposal should be utilized. Handling and disposal of clofarabine injection should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Clofarabine injection is supplied in single-dose 20 mL clear tubular USP Type-I vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 60505-6166-0). The 20 mL tubular USP Type-I clear vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.Vials containing undiluted clofarabine injection should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.Procedures for proper handling and disposal should be utilized. Handling and disposal of clofarabine injection should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Clofarabine injection is supplied in single-dose 20 mL clear tubular USP Type-I vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 60505-6166-0). The 20 mL tubular USP Type-I clear vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.Vials containing undiluted clofarabine injection should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.Procedures for proper handling and disposal should be utilized. Handling and disposal of clofarabine injection should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Clofarabine injection is supplied in single-dose 20 mL clear tubular USP Type-I vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 60505-6166-0). The 20 mL tubular USP Type-I clear vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.Vials containing undiluted clofarabine injection should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.Procedures for proper handling and disposal should be utilized. Handling and disposal of clofarabine injection should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clofarabine is sequentially metabolized intracellularly to the 5'-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5'-triphosphate metabolite. Clofarabine has affinity for the activating phosphorylating enzyme, deoxycytidine kinase, equal to or greater than that of the natural substrate, deoxycytidine. Clofarabine inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through 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. The affinity of clofarabine triphosphate for these enzymes is similar to or greater than that of deoxyadenosine triphosphate. In preclinical models, clofarabine has demonstrated the ability to inhibit DNA repair by incorporation into the DNA chain during the repair process. Clofarabine 5'-triphosphate also disrupts the integrity of mitochondrial membrane, leading to the release of the pro-apoptotic mitochondrial proteins, cytochrome C and apoptosis-inducing factor, leading to programmed cell death.
Clofarabine is cytotoxic to rapidly proliferating and quiescent cancer cell types .
Non-Clinical Toxicology
NoneClofarabine injection causes myelosuppression which may be severe and prolonged. Febrile neutropenia occurred in 55% and non-febrile neutropenia in an additional 10% of pediatric patients in clinical trials. At initiation of treatment, most patients in the clinical studies had hematological impairment as a manifestation of leukemia. Myelosuppression is usually reversible with interruption of clofarabine injection treatment and appears to be dose-dependent. Monitor complete blood counts [ ].
The following adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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