Label Changes for:
Clolar (clofarabine) Injection
January 2013
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2013
6 ADVERSE REACTIONS
6.2 Post-marketing Experience
- Gastrointestinal disorders: Gastrointestinal hemorrhage including fatalities.
- added ..... Other exfoliative conditions have also been reported
7 DRUG INTERACTIONS
- No in-vivo drug interaction studies have been conducted [see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.7 Renal Impairment
- Reduce the Clolar starting dose by 50% in patients with CrCL of 30 to 60 mL/min. There is insufficient information to make a dosage recommendation in patients with CrCL less than 30 mL/min or in patients on dialysis. The pharmacokinetics of clofarabine in patients with renal impairment and normal renal function were obtained from a population pharmacokinetic analysis of three pediatric and two adult studies. In patients with CrCL 60 to less than 90 mL/min (N = 47) and CrCL 30 to less than 60 mL/min (N = 30), the average AUC of clofarabine increased by 60% and 140%, respectively, compared to patients with normal (N = 66) renal function (CrCL greater than 90 mL/min).
8.8 Hepatic Impairment
- Clolar has not been studied in patients with hepatic impairment.
