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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. FDA Overview of Parenteral Iron Products

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Injectafer ® (Ferric Carboxymaltose)

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  1. 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

  2. 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

  3. FDA Overview of Parenteral Iron Products Kathy Robie Suh, M.D., Ph.D. Division of Medical Imaging and Hematology Products February 1, 2008

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

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