Label Changes for:

NovoLog (insulin aspart [rDNA origin] injection) Solution for Subcutaneous Use

March 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Hypersensitivity and Allergic Reactions
    • Systemic Reactions

ADVERSE REACTIONS

  • Clinical Trial Experience
    • Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus
    • Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus

PATIENT PACKAGE INSERT

  • How should I take NovoLog?
    • Read the instructions for use that come with your NovoLog product...
      • If you take too much NovoLog...
      • If you forget to take your dose of NovoLog...
  • What are the possible side effects of NovoLog?
    • Serious allergic reaction (whole body reaction)...
    • Call your doctor for medical advice about side effects...

PATIENT INSTRUCTIONS FOR USE:

  • NovoLog FlexPen Prefilled Syringe
  • NovoLog 3 mL PenFill Cartridge

WARNINGS AND PRECAUTIONS

Hypersensitivity and Allergic Reactions

Systemic Reactions - Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin product, including NovoLog. Anaphylactic reactions with NovoLog have been reported post-approval. Generalized allergy to insulin may also cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis...

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