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Clofarabine (Clolar)

Trade Name : Clolar

Sanofi-Aventis U.S. LLC

INJECTION

Strength 1 mg/mL

CLOFARABINE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clofarabine (Clolar) which is also known as Clolar and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 1 mg/mL per ml. Read more

Clofarabine (Clolar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clolar.
  • Clolar 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. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clolar. ()
  • No data
  • Administer the recommended pediatric dose of 52 mg/m as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28-day cycle. Repeat cycles every 2u20136 weeks. ()
  • Provide supportive care, such as intravenous infusion fluids, antihyperuricemic treatment, and alkalinization of urine throughout the 5 days of Clolar administration to reduce the risk of tumor lysis and other adverse reactions. ()
  • Discontinue Clolar if hypotension develops during the 5 days of administration. ()
  • Reduce the dose in patients with renal impairment. ()
  • Use dose modification for toxicity. ()
  • Injection: 20 mg/20 mL (1 mg/mL) clear solution in single-dose vial
  • Injection: 20 mg/20 mL (1 mg/mL) single-dose vial. ()
  • None.
  • None. ()
  • No data
  • Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during Clolar therapy. ()
  • Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. ()
  • Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue Clolar and treat promptly. ()
  • Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. ()
  • Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue Clolar immediately if suspected. ()
  • Venous Occlusive Disease of the Liver: Monitor for and discontinue Clolar if suspected. ()
  • Hepatotoxicity: Severe and fatal hepatotoxicity. Monitor liver function, for signs and symptoms of hepatitis and hepatic failure. Discontinue Clolar immediately for Grade 3 or greater liver enzyme and/or bilirubin elevations. ()
  • Renal Toxicity: Increased creatinine and acute renal failure; monitor renal function and interrupt or discontinue Clolar. ()
  • Enterocolitis: Serious and fatal enterocolitis, occurring more frequently within 30 days of treatment and with combination chemotherapy. Monitor patients for signs and symptoms of enterocolitis and treat promptly. ()
  • Skin Reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases. Discontinue for exfoliative or bullous rash, or if SJS or TEN is suspected. ()
  • Embryo-Fetal Toxicity: Can cause fetal harm. ()
  • The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:
  • Most common adverse reactions (u226525%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-RX-CLOLAR or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Lactation: Advise not to breastfeed. ()
  • There were no known overdoses of Clolar. The highest daily dose administered to a human to date (on a mg/m basis) has been 70 mg/m/day u00d7 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.
  • Clolar (clofarabine) injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-u03b2-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is CHClFNO with a molecular weight of 303.68 Daltons.
  • The molecular structure of clofarabine is:
  • Clolar (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.
  • No data
  • Clofarabine has not been tested for carcinogenic potential.
  • Clofarabine was clastogenic in the mammalian cell chromosome aberration assay (CHO cells) and in the rat micronucleus assay. Clofarabine was not mutagenic in the bacterial mutation assay (Ames test).
  • Studies in mice, rats, and dogs have demonstrated dose-related adverse effects on male reproductive organs. Seminiferous tubule and testicular degeneration and atrophy were reported in male mice receiving intraperitoneal doses of 3 mg/kg/day (approximately 0.2-times the recommended human dose based on body surface area [BSA]). Rats receiving 25 mg/kg/day (approximately 3-times the recommended human dose based on BSA) in a 6-month intravenous study had testicular findings of bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells. In a 6-month intravenous dog study, cell degeneration of the epididymis and degeneration of the seminiferous epithelium in the testes were observed at 0.375 mg/kg/day (approximately 0.1-times the recommended human dose on a BSA basis). Ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at 75 mg/kg/day (approximately 4-times the recommended human dose on a mg/m basis), the only dose administered to female mice.
  • Seventy-eight (78) pediatric patients with ALL were exposed to Clolar. Seventy (70) of the patients received the recommended pediatric dose of Clolar 52 mg/m daily for 5 days as an intravenous infusion.
  • No data
  • Clolar (clofarabine) injection is supplied in single-dose flint vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one Clolar vial (NDC 0024-5860-01). The 20-mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, is preservative-free, and is free from foreign matter.
  • Vials containing undiluted Clolar should be stored at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F). Do not freeze. Retain in carton until contents are used.
  • Clolar is a cytotoxic drug. Follow applicable special handling and disposal procedures.n
  • No data
  • Manufactured by:Teva PharmachemieSwensweg 5 Haarlem, The Netherlands
  • Manufactured for:Genzyme CorporationCambridge, MA 02142
  • www.clolar.com
  • u00a92019 Genzyme Corporation. All rights reserved.
  • Clolar is a registered trademark of Genzyme Corporation.
  • NDC 0024-5860-01
  • Clolarn clofarabine injection
  • Each vial contains20 mg/20 mL (1 mg/mL)
  • Must Be Diluted PriorTo Intravenous Use
  • Contains 1 (20 mL)single-dose vial
  • SANOFI
  • Rx only

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