pharmaceuticals [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 100 109/L and absolute neutrophil count (ANC) 1.0 109/L]. CRp was defined as meeting all criteria for CR except for recovery of platelet counts to 100 109/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 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 N = 61 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) 1 10.7 (4.3 to 58.6) CR = Complete response CRp = Complete response without platelet recovery 1 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). 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 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html. How Supplied/Storage and Handling Clofarabine Injection is supplied in single-dose flint vials containing 20 mg 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. Vials containing undiluted Clofarabine Injection should be stored at 20 to 25 C (68 to 77 F); excursions permitted between 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. 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. 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) and 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) and 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 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 [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) and 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 clofarabine treatment [see Use in Specific Populations (8.3) ] . 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 [see Warnings and Precautions (5.9) ] . Rash : Advise patients that they may experience skin rash with clofarabine. If this symptom is significant, they should seek medical attention. Manufactured by: Amneal Oncology Pvt. Ltd. Plot No S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally, Mandal-Jadcherla, Mahaboobnagar, Telangana 509301, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev. 08-2017-00 PRINCIPAL DISPLAY PANEL NDC 70121-1236-1 Strength: 20 mg/20 mL R x only Vial Label Amneal Biosciences LLC NDC 70121-1236-1 Strength: 20 mg/20 mL R x only Carton Label Amneal Biosciences LLC CLOFARABINE Clofarabine Injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70121-1236 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 WATER SODIUM CHLORIDE Packaging # Item Code Package Description 1 NDC:70121-1236-1 1 VIAL, SINGLE-DOSE in 1 BOX 1 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208857 11/06/2017 Labeler - Amneal Biosciences LLC (079785595) Revised: 11/2017 Amneal Biosciences LLC Next Interactions Print this page Add to My Med List More about clofarabine Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antimetabolites Consumer resources Clofarabine Clofarabine Intravenous (Advanced Reading) Professional resources Clofarabine (AHFS Monograph) Clofarabine (Wolters Kluwer) Other brands: Clolar 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 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 , blinatumomab , pegaspargase , tisagenlecleucel , teniposide , More... 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