Trade Name: Clofarabine

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/mL

Storage and handling

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

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  • No data
  • 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.
  • 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. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection. n n n
  • 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 2 to 6 weeks. n
  • 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. n
  • Discontinue clofarabine injection if hypotension develops during the 5 days of administration. ()
  • Reduce the dose in patients with renal impairment. (2.2)
  • Use dose modification for toxicity. (2.4)n n
  • 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. (n n
  • None.
  • None. n u00a0
  • No data
  • Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during clofarabine therapy. n
  • Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. n
  • Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue clofarabine and treat promptly. n
  • Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. n
  • Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue clofarabine immediately if suspected.u00a0u00a0
  • Venous Occlusive Disease of the Liver: Monitor for and discontinue clofarabine if suspected.u00a0u00a0
  • Hepatotoxicity: Severe and fatal hepatotoxicity. Monitor liver function, for signs and symptoms of hepatitis and hepatic failure. Discontinue clofarabine immediately for Grade 3 or greater liver enzyme and/or bilirubin elevations.u00a0u00a0
  • Renal Toxicity: Increased creatinine and acute renal failure; monitor renal function and interrupt or discontinue clofarabine. n
  • 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. n
  • 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. n
  • Embryo-Fetal Toxicity: Can cause fetal harm. (5.11)
  • The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:
  • Most common adverse reactions (u2265 25%): 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Lactation: Advise not to breastfeed. (8.2)n
  • There were no known overdoses of clofarabine. 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.
  • 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:
  • 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.
  • 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 u00a0in 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 u00a0u00a0doses of 3 mg/kg/day u00a0(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 clofarabine. Seventy (70) of the patients received the recommended pediatric dose of clofarabine 52 mg/m daily for 5 days as an intravenous u00a0infusion.
  • Dose Escalation Study in Pediatric Patients with Hematologic Malignancies
  • The safety and efficacy of clofarabine were evaluated in pediatric patients with refractory or relapsed hematologic malignancies in an open-label, dose-escalation, noncomparative study (NCT00042341, A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia). The starting dose of clofarabine was 11.25 mg/m/day intravenous infusion daily u00d7 5 and escalated to 70 mg/m/day intravenous infusion daily u00d7 5. This dosing schedule was repeated every 2 to 6 weeks depending on toxicity and response. Nine of 17 ALL patients were treated with clofarabine 52 mg/m daily for 5 days. In the 17 ALL patients there were 2 complete remissions (12%) and 2 partial remissions (12%) at varying doses. Dose-limiting toxicities u00a0in this study were reversible hyperbilirubinemia and elevated transaminase levels and skin rash, experienced at 70 mg/m. As a result of this study, the recommended dose for subsequent study in pediatric patients was determined to be 52 mg/m/day for 5 days.
  • Single-Arm Study in Pediatric ALL
  • Clofarabine was evaluated in an open-label, single-arm study of 61 pediatric patients with relapsed/refractory ALL. Patients received a dose of 52 mg/m intravenous infusion over 2 hours for 5 consecutive days repeated every 2 to 6 weeks for up to 12 cycles. There was no dose escalation in this study.
  • All patients had disease that had relapsed after and/or was refractory to two or more prior therapies. Most patients, 38/61 (62%), had received > 2 prior regimens and 18/61 (30%) of the patients had undergone at least 1 prior transplant. The median age of the treated patients was 12 years, 61% were male, 39% were female, 44% were Caucasian, 38% were Hispanic, 12% were African-American, 2% were Asian and 5% were Other race.
  • The overall remission (OR) rate (Complete Remission [CR] + CR in the absence of total platelet recovery [CRp]) was evaluated. CR was defined as no evidence of circulating blasts or extramedullary disease, an M1 bone marrow (u2264 5% blasts), and recovery of peripheral counts [platelets u2265 100 u00d7 10/L and absolute neutrophil count (ANC) u2265 1 u00d7 10/L]. CRp was defined as meeting all criteria for CR except for recovery of platelet counts to u2265 100 u00d7 10/L. Partial Response (PR) was also determined, defined as complete disappearance of circulating blasts, an M2 bone marrow (u2265 5% and u2264 25% blasts), and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. Duration of remission was also evaluated. Transplantation rate was not a study endpoint.
  • Response rates for these studies were determined by an unblinded Independent Response Review Panel (IRRP).
  • Table 3 summarizes results for the pediatric ALL study. Responses were seen in both pre-B and T-cell immunophenotypes of ALL. The median cumulative dose was 530 mg (range 29 to 2815 mg) in 1 (41%), 2 (44%) or 3 or more (15%) cycles. The median number of cycles was 2 (range 1 to 12). The median time between cycles was 28 days with a range of 12 to 55 days.
  • Table 3: Results in Single-Arm Pediatric ALL
  • Six (9.8%) patients achieved a PR; the clinical relevance of a PR in this setting is unknown.
  • Of 35 patients who were refractory to their immediately preceding induction regimen, 6 (17%) achieved a CR or CRp. Of 18 patients who had at least 1 prior hematopoietic stem cell transplant (HSCT), 5 (28%) achieved a CR or CRp.
  • Among the 12 patients who achieved at least a CRp, 6 patients achieved the best response after 1 cycle of clofarabine, 5 patients required 2 courses and 1 patient achieved a CR after 3 cycles of therapy.
  • u00a0u00a0u00a0u00a0 1.u00a0u00a0u00a0 OSHA Hazardous Drugs. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • Clofarabine injection is supplied in single-dose flint vials containing of clofarabine in 20 mL of solution. Each box contains one clofarabine injection vial (NDC 70121-1236-1). 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 colorless, is preservative-free, and is free from foreign matter.
  • Vials containing undiluted clofarabine injection should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Do not freeze. Retain in carton until contents are used.n
  • Clofarabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.
  • Hematologic Toxicity
  • Advise patients to return for regular blood counts and to report any symptoms associated with hematologic toxicity (such as weakness, fatigue, pallor, shortness of breath, easy bruising, petechiae, purpura, fever) to their physician .
  • Infection
  • Advise patients of the signs or symptoms of infection (e.g., fever) and report to the physician immediately if any occur .
  • Hepatic and Renal Toxicity
  • Advise patients to avoid medications including over the counter and herbal medications, which may be hepatotoxic or nephrotoxic, during the 5 days of clofarabine administration. Also, advise patients of the possibility of developing liver function abnormalities and to immediately report signs or symptoms of jaundice. Advise patients of the signs or symptoms of renal failure/acute renal failure .
  • Systemic Inflammatory Response Syndrome (SIRS)/Capillary Leak Syndrome
  • Advise patients of the signs or symptoms of SIRS, such as fever, tachycardia, tachypnea, dyspnea and symptoms suggestive of hypotension .
  • Pregnancy
  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy . Advise female patients of reproductive potential to use effective contraception during treatment with clofarabine and for at least 6 months after the last dose . Advise males with female partners of reproductive potential to use effective contraception during treatment with clofarabine and for at least 3 months after the last dose .
  • Lactation
  • Advise females not to breastfeed during treatment with clofarabine and for 2 weeks after the last dose .
  • Gastrointestinal Disorders
  • Advise patients that they may experience nausea, vomiting, and/or diarrhea with clofarabine. If these symptoms are significant, they should seek medical attention .
  • Rash
  • Advise patients that they may experience skin rash with clofarabine. If this symptom is significant, they should seek medical attention.
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 01-2020-01
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Clofarabine (Clofarabine) which is also known as Clofarabine and Manufactured by Amneal Biosciences LLC. It is available in strength of 1 mg/mL.

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