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U.S. Department of Health and Human Services

Safety

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Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.


 

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Dosage Adjustment and Monitoring
  • Hypoglycemia
  • Hypokalemia
  • Renal or Hepatic Impairment

ADVERSE REACTIONS

  • Clinical Trial Experience
    • Table 1
    • Table 2
    • Pediatrics (new subsection)
      • Table 3
    • Severe Symptomatic Hypoglycemia
      • Table 4 (new pediatric data)
    • Insulin Initiation and Intensification of Glucose Control
    • Lipodystrophy
    • Weight Gain
    • Peripheral Edema
    • Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
      • Table 5
    • Allergic Reactions
      • Local Allergy
      • Systemic Allergy
      • Antibody Production
  • Postmarketing Experience (new subsection)

DRUG INTERACTIONS

  • Drugs that may increase the blood glucose-lowering effect of insulins including Apidra...
    • Pramlintide (added)
    • Somatostatin Analogs (added)
  • Drugs that may reduce the blood glucose-lowering effect of Apidra...
    • Niacin (added)

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

PATIENT COUNSELING INFORMATION

  • For Patients Using Continuous Subcutaneous Insulin Pumps
    • ...Before using a different pump with Apidra, read the pump label to make sure the pump has been evaluated with Apidra.

PATIENT PACKAGE INSERTS

Apidra 10 mL vial (1000 units per vial) - 100 units per mL (U-100)

  • What is diabetes?
  • What is Apidra?
  • Who should not take Apidra?
  • How should I infuse Apidra with an external insulin infusion pump?

Apidra 3 mL cartridge system (300 units per cartridge system) - 100 units per mL (U-100)

  • What is diabetes?
  • What is Apidra?
  • Who should not take Apidra?
     

CONTRAINDICATIONS

Apidra is contraindicated:

...When used in patients with known hypersensitivity to Apidra or its excipients, patients may develop localized or generalized hypersensitivity reactions [See Adverse Reactions (6.1)].

WARNINGS AND PRECAUTIONS

Dosage Adjustment and Monitoring:

Glucose monitoring is essential for patients receiving insulin therapy...

Hypoglycemia:

...The risk of hypoglycemia increases with tighter glycemic control. Patients must be educated to recognize and manage hypoglycemia...

...Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin, requiring closer monitoring for hypoglycemia.

Hypokalemia:

All insulin products, including Apidra, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations)...

Renal or Hepatic Impairment:

Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment [See Clinical Pharmacology (12.4)].