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Label Changes for:

Doxorubicin (doxorubicin hydrochloride) for injection

September 2011

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011



New Patient Package Insert:


DOXORUBICIN  (doxorubicin hydrochloride) for Injection

Read this Patient information before you start receiving Doxorubicin and before each infusion. This information leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Doxorubicin?

Doxorubicin may cause serious side effects including:

  • Heart problems. Doxorubicin may cause heart problems that may lead to death. These problems can happen during your treatment or months to years after stopping treatment. In some cases heart problems are irreversible. Your chance of heart problems is higher if you:
    • already have heart problems
    • have a history of radiation therapy or are…