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Label Changes for:

Hectorol (doxercalciferol)

June 2016

Changes have been made to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS sections of the safety label.

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

June 2016

CONTRAINDICATIONS

  • (addition) Hectorol Injection is contraindicated in patients with previous hypersensitivity to doxercalciferol or any of its ingredients.

WARNINGS

  • (addition to bottom of section) Serious hypersensitivity reactions, including fatal outcome,  have been reported post marketing in patients on hemodialysis following administration of Hectorol Injection. Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest. These reactions may occur separately or together. Monitor patients receiving Hectorol Injection upon initiation of treatment for hypersensitivity reactions. Should a hypersensitivity reaction occur, discontinue Hectorol, monitor and treat if indicated.
  • Monitor patients receiving Hectorol Injection upon initiation of treatment for hypersensitivity reactions. Should a hypersensitivity reaction occur, discontinue Hectorol, monitor and treat if indicated.

ADVERSE REACTIONS

Postmarketing Experience
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
  • Hypersensitivity reactions, including fatal outcome, have been reported in patients on hemodialysis following administration of Hectorol Injection. Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus and skin burning sensation. These reactions may occur separately or together.
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