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U.S. Department of Health and Human Services

Safety

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R-Gene 10 (arginine hydrochloride) injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

 

Summary View

 

WARNINGS

  • Hypersensitivity reactions, including anaphylaxis have been reported. Appropriate medical support should be available during R-Gene 10 administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene 10 should be discontinued and appropriate medical treatment initiated.

ADVERSE REACTIONS

Post Marketing Experience
  • The following adverse events have been reported during post-marketing use: extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention, hypersensitivity reactions including anaphylaxis, and hematuria that in some cases occurred 1-2 days after an R-Gene 10 administration. Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.