flesh presser [0.5:2 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 ( 5% blasts), and recovery of peripheral counts [platelets 100 10 9 /L and absolute neutrophil count (ANC) 1.0 10 9 /L]. CRp was defined as meeting all criteria for CR except for recovery of platelet counts to 100 10 9 /L. Partial Response (PR) was also determined, defined as complete disappearance of circulating blasts, an M2 bone marrow ( 5% and 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 2815 mg) in 1 (41%), 2 (44%) or 3 or more (15%) cycles. The median number of cycles was 2 (range 1 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 N=61 CR = Complete response CRp = Complete response without platelet recovery * Does not include 4 patients who were transplanted (duration of response, including response after transplant, in these 4 patients was 28.6 to 107.7 weeks). CR % [95% CI] 11.5 (4.7, 22.2) CRp % [95% CI] 8.2 (2.7, 18.1) Median Duration of CR plus CRp (range in weeks) * 10.7 (4.3 to 58.6) 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. REFERENCES OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html. How Supplied/Storage and Handling 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 0024-5917-01). The 20mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5. Vials containing undiluted Clolar 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 Clolar should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. 1 Patient Counseling Information 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 [ see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Infection: Advise patients of the signs or symptoms of infection (e.g., fever) and report to the physician immediately if any occur [ see Warnings and Precautions (5.3) , Adverse Reactions (6.1) ]. 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 Clolar 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 [ see Warnings and Precautions (5.7 , 5.8) ]. 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 [ see Warnings and Precautions (5.5) , Adverse Reactions (6.1) ]. Pregnancy and Breastfeeding: Advise male and female patients with reproductive potential to use effective contraceptive measures to prevent pregnancy [ see Warnings and Precautions (5.11) , Use in Specific Populations (8.1) ]. Advise female patients to avoid breastfeeding during Clolar treatment [ see Use in Specific Populations (8.3) ]. Gastrointestinal Disorders : Advise patients that they may experience nausea, vomiting, and/or diarrhea with Clolar. If these symptoms are significant, they should seek medical attention [ see Warnings and Precautions (5.9) ]. Rash : Advise patients that they may experience skin rash with Clolar. If this symptom is significant, they should seek medical attention. Manufactured by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Manufactured for: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 Distributed by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 www.Clolar.com 2017 Genzyme Corporation. All rights reserved. Clolar is a registered trademark of Genzyme Corporation. NOVAPLUS is a registered trademark of Vizient, Inc. Revised: 02/2017 PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton NDC 0024-5917-01 Rx ONLY Clolar clofarabine injection Each vial contains 20 mg/ 20 mL (1 mg/mL) Must Be Diluted Prior To Intravenous Use Each single-use 20 mL vial contains 20 mg clofarabine dissolved in 20 mL of sodium chloride injection, USP 0.9%, pH 4.5 7.5. Contains no preservatives. Sterile. NOVAPLUS Clolar clofarabine injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5917 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOFARABINE (CLOFARABINE) CLOFARABINE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 9 mg in 1 mL WATER Packaging # Item Code Package Description 1 NDC:0024-5917-01 1 VIAL, SINGLE-USE in 1 BOX 1 20 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021673 07/01/2017 Labeler - sanofi-aventis U.S. LLC (824676584) Establishment Name Address ID/FEI Operations Pharmachemie B.V. 402108922 MANUFACTURE(0024-5917), ANALYSIS(0024-5917), LABEL(0024-5917), PACK(0024-5917) Revised: 05/2017 sanofi-aventis U.S. LLC Next Interactions Print this page Add to My Med List More about Clolar (clofarabine) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Generic Availability Drug class: antimetabolites Consumer resources Clolar Clolar (Advanced Reading) Professional resources Clolar (AHFS Monograph) Clofarabine Injection (FDA) Related treatment guides Acute Lymphoblastic Leukemia] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Sanofi-Aventis U.S. LLC Drug Class Antimetabolites Related Drugs antimetabolites methotrexate , fluorouracil , hydroxyurea , Xeloda , capecitabine , Hydrea Acute Lymphoblastic Leukemia methotrexate , Gleevec , mercaptopurine , imatinib , Adriamycin , doxorubicin , Sprycel , Trexall , dasatinib , Purinethol , Kymriah , Besponsa , Iclusig , Blincyto , ponatinib , Purixan , clofarabine , Xatmep , Oncaspar , Marqibo , asparaginase erwinia chrysanthemi , blinatumomab , pegaspargase , tisagenlecleucel , More... 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