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OBR OncologyFDA Updates Temozolomide Indications and Dosing

The approval was made under the Project Renewal Initiative

The US Food and Drug Administration (FDA) has recently approved updated labeling for the cancer medication temozolomide, making it the second drug to undergo such changes under the Project Renewal pilot program. This program aims to review and update labels for older cancer medications to ensure they are scientifically current and meaningful.

HCN Medical Memo
The FDA’s updated labeling for temozolomide offers a more current and comprehensive guide for its use. The changes, part of the Project Renewal initiative, reflect the FDA’s commitment to keeping healthcare providers informed with the most up-to-date information. Physicians should be particularly attentive to the new dosing guidelines and adverse reaction data when considering temozolomide for their patients.

Key Points:
  • The FDA approved revised indications for temozolomide, including its use in treating adults with refractory anaplastic astrocytoma and as an adjuvant treatment for adults with newly diagnosed anaplastic astrocytoma.
  • The Project Renewal program, part of the Oncology Center of Excellence, focuses on updating labels for older, commonly prescribed cancer drugs based on publicly available evidence.
  • The most common adverse reactions for temozolomide include alopecia, headache, fatigue, vomiting, nausea, constipation, anorexia, and convulsions.
  • Physicians should note that severe and even fatal hepatotoxicity have been reported. Liver tests are advised at various stages of treatment.

Temozolomide was initially approved by the FDA in 1999 and is now the second drug to have its labeling updated under the Project Renewal program.

Additional Points:
  • Dosing guidelines for temozolomide have been revised and updated.
  • New warnings and precautions have been added, including risks from exposure to opened capsules and the potential harm to a fetus.
  • The Patient Counseling Information section and the Patient Information document were also revised.

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