Luhan Pharmachem Co., Ltd.

Luhan pharmachem Co., Ltd. supplies Clofarabine bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Clofarabine is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

Clofarabine Description

Clolar (clofarabine) injection contains clofarabine, a purine nucleosideanti-metabolite. Clolar(1 mg/mL) is supplied in a 20 mL, here 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). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and free from foreign matter.
The chemical structure of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-?-D-arabinofuranosyl)-9H-purin-6-amine. The molecular formula of clofarabine is C10H11ClFN5O3 with a molecular weight of 303.68.

Clofarabine Indications

Clolar 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. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Clofarabine Dosage and Administration

Recommended Dose

Clolar should be filtered through a sterile 0.2 µm syringe filter and then diluted with 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, prior to intravenous (IV) infusion to a final concentration between 0.15 mg/mL and 0.4 mg/mL. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation.

The recommended pediatric dose and schedule is 52 mg/m2 administered by intravenous (IV) infusion over 2 hours daily for 5 consecutive days. Treatment cycles are repeated following recovery or return to baseline organ function, approximately every 2 to 6 weeks. The dosage is based on the patient’s body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same intravenous line.
Clolar has not been studied in patients with hepatic or renal dysfunction. Its use in such patients should be undertaken only with the greatest caution.

Physicians are encouraged to give continuous IV infusion fluids throughout the 5 days of Clolar administration to reduce the effects of tumor lysis and other adverse events. The use of prophylactic steroids (e.g., 100 mg/m2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak (e.g., hypotension). If patients show early signs or symptoms of SIRS or capillary leak (e.g., hypotension), the physician should immediately discontinue Clolar administration and provide appropriate supportive measures. Close monitoring of renal and hepatic function during the 5 days of Clolar administration is advised. If substantial increases in creatinine or bilirubin are noted, physicians should immediately discontinue administration of Clolar . Clolar should be re-instituted when the patient is stable and organ function has returned to baseline, possibly with a 25% dose reduction. If hyperuricemia is anticipated (tumor lysis), patients should prophylactically receive allopurinol.

Storage and Handling

Vials containing undiluted Clolar should be stored at 25C (77F); excursions permitted to 15-30C (59-86F).

Diluted admixtures may be stored at room tempera-ture, but must be used within 24 hours of preparation.

Clofarabine Side Effects

One hundred thirteen (113) pediatric patients with ALL (67) or AML (46) were exposed to Clolar. Ninety-six (96) of the pediatric patients treated in clinical trials received the recommended dose of Clolar 52 mg/m2 daily x 5.

The most common adverse effects after Clolar treatment, regardless of causality, were gastrointestinal tract symptoms, including vomiting, nausea, and diarrhea; hematologic effects, including anemia, leukopenia, thrombocytopenia, neutropenia, and febrile neutropenia; and infection.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.