injectafer ferric carboxymaltose l.
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Injectafer ® (Ferric Carboxymaltose). Drug Safety and Risk Management Advisory Committee February 1, 2008 Kathy Robie Suh, MD, PhD Division of Medical Imaging and Hematology Products FDA/CDER/OODP. Injectafer FDA Presentations. FDA Overview of Parenteral Iron Products

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injectafer ferric carboxymaltose
Injectafer®(Ferric Carboxymaltose)

Drug Safety and Risk Management

Advisory Committee

February 1, 2008

Kathy Robie Suh, MD, PhD

Division of Medical Imaging and Hematology Products

FDA/CDER/OODP

injectafer fda presentations
Injectafer FDA Presentations
  • FDA Overview of Parenteral Iron Products

--- Dr. Kathy Robie Suh, DMIHP/OODP

  • Injectafer Clinical Pharmacology

--- Dr. Christy John, OCP

  • Injectafer Efficacy and Safety

--- Dr. Min Lu, DMIHP/OOPD

fda overview of parenteral iron products
FDA Overview of Parenteral Iron Products

Kathy Robie Suh, M.D., Ph.D.

Division of Medical Imaging and Hematology Products

February 1, 2008

approved parenteral iron products
Approved Parenteral Iron Products
  • Iron dextran (e.g., INFeD, Dexferrum), first approved 1968
  • Ferrlecit (sodium ferric gluconate complex), approved 1999
  • Venofer (iron sucrose), approved 2000
iron dextran
Iron Dextran
  • Indication
    • Documented iron deficiency, when
    • Oral administration is unsatisfactory or impossible
  • Dosage and Administration
    • Test dose recommended
    • Max single daily dose: 100 mg
  • Warnings
    • Boxed warning
boxed warning
Boxed Warning
  • Anaphylactic-type reactions, including deaths
  • Use only in those patients with iron deficiency:
    • Verified with lab tests
    • Not amenable to oral iron therapy.
  • Resuscitation techniques and treatment of anaphylaxis and anaphylactoid shock must be readily available.
ferrlecit sodium ferric gluconate
Ferrlecit (sodium ferric gluconate)
  • Indication: Iron deficiency anemia in patients undergoing hemodialysis & receiving Epo
  • Dosage and Administration
    • Maximum daily dose: 125 mg
    • Test dose not required
  • Warning: Hypersensitivity
venofer iron sucrose
Venofer (iron sucrose)
  • Indication: iron deficiency anemia in patients with chronic kidney disease:
    • Hemodialysis or peritoneal dialysis & Epo
    • Non-dialysis
  • Dosage and Administration
    • Max daily dose:
      • 100 mg in hemodialysis
      • 400 mg in peritoneal dialysis
      • 200 mg in non-dialysis
    • No test dose
  • Warning: Hypersensitivity
safety issues for parenteral iron products
Safety Issues for Parenteral Iron Products
  • Hypersensitivity reactions
  • Cardiovascular – hypotension
  • Dosing concerns: max daily dose
    • Generally ≤ 200 mg
    • Venofer: 400 mg in patients receiving peritoneal dialysis
injectafer fda presentations10
Injectafer: FDA Presentations
  • FDA Overview of Parenteral Iron Products

--- Dr. Kathy Robie Suh, DMIHP/OODP

  • Injectafer Clinical Pharamcology

--- Dr. Christy John, OCP

  • Injectafer Efficacy and Safety

--- Dr. Min Lu, DMIHP/OOPD