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Label Changes for:

Clolar (clofarabine) Injection

December 2015

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

December 2015

WARNINGS AND PRECAUTIONS

Hepatotoxicity
  • including hepatitis and hepatic failure,

ADVERSE REACTIONS

Post-marketing Experience
  • Hepatobiliary disorders: Cases of hepatitis and hepatic failure have been reported, including fatal outcomes

 

September 2014

5 WARNINGS AND PRECAUTIONS

5.2 Hemorrhage
5.9 Entercolitis
5.10 Skin Reactions
  • new sections added

6 ADVERSE REACTIONS

6.2 Postamarketing Experience
  • added ..... hyponatremia

 

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. 

 

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