These highlights do not include all the information needed to use CLOFARABINE INJECTION safely and effectively. See full prescribing information for CLOFARABINE INJECTION.
CLOFARABINE injection, for intravenous use
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
Warnings and Precautions (5.7) 12/2015
Warnings and Precautions (5.8) 10/2016
INDICATIONS AND USAGE
Clofarabine injection is a purine 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. (1)
DOSAGE AND ADMINISTRATION
Administer the recommended pediatric dose of 52 mg/m2 as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28 day cycle. Repeat cycles every 2 to 6 weeks. (2.1)
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 events. (2.1)
Discontinue Clofarabine Injection if hypotension develops during the 5 days of administration. (2.1)
Reduce the dose in patients with renal impairment. (2.1)
Use dose modification for toxicity. (2.3)
DOSAGE FORMS AND STRENGTHS
20 mg/20 mL single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during Clofarabine therapy. (5.1)
Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage. Monitor platelets and coagulation parameters and treat accordingly. (5.2)
Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue Clofarabine and treat promptly. (5.3)
Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. (5.4)
Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue Clofarabine immediately if suspected. (5.5)
Venous Occlusive Disease of the Liver: Monitor for and discontinue Clofarabine if suspected. (5.6)
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. (5.7)
Renal Toxicity: Increased creatinine and acute renal failure; monitor renal function and interrupt or discontinue Clofarabine. (5.8)
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. (5.9)
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. (5.10)
ADVERSE REACTIONS
Most common adverse reactions (? 25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Embryo-fetal Toxicity: fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving Clofarabine. (5.11, 8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2017
