Label Changes for:

Arava (leflunomide) Tablets

November 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

November 2012

ADVERSE REACTIONS

Post-Marketing Experience
  • cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis

 

July 2011

WARNINGS

  • Peripheral neuropathy section added

PRECAUTIONS

Respiratory
  • .....risk of interstitial lung disease

 

September 2010

BOXED WARNING

  • If ALT elevation > 3 fold ULN occurs, interrupt Arava therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of Arava therapy may be considered.

WARNINGS

Hepatotoxicity
  • If ALT elevation > 3 fold ULN occurs, interrupt Arava therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of Arava therapy may be considered.

 

 

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