Safety

Halaven (Eribulin Mesylate) Injection

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

January 2016

Summary View

WARNINGS AND PRECAUTIONS

Neutropenia
  • *edits to this section
Peripheral Neuropathy
  • *edits to this section
Embryo-Fetal Toxicity
  • *edits to this section

 

August 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Blood and Lymphatic System Disorders: lymphopenia …
  • Hepatobiliary Disorders: hepatotoxicity
  • Immune System Disorders: drug hypersensitivity
  • Infections and Infestations: pneumonia, sepsis/neutropenic sepsis
  • Metabolism and Nutrition Disorders: hypomagnesemia, dehydration
  • Respiratory, thoracic and mediastinal disorders: interstitial lung disease
  • Skin and Subcutaneous Tissue Disorders: pruritus

 

August 2013

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse drug reaction has been identified during post-approval of HALAVEN. Because these reactions 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. Gastrointestinal Disorders: Pancreatitis 

 

Page Last Updated: 02/12/2016
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