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U.S. Department of Health and Human Services

Safety

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Doxorubicin (doxorubicin hydrochloride) for injection

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

 

Summary View

PATIENT PACKAGE INSERT

New Patient Package Insert:

PATIENT INFORMATION

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…