Infusion-Related Reactions

The DOXIL® Patient Starter Kit fact sheet

Infusion-related reactions occurred in 10% of DOXIL®-treated patients in clinical trials. Prompt identification and management of infusion-related reactions can help optimize therapy.

Use the tabs below to learn more about managing infusion-related reactions associated with DOXIL® therapy.

  • BOXED WARNINGS
  • Identification
  • Management
  • Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL®. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate
    • Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
    • The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions

Identifying Infusion-Related Reactions

Acute infusion-related reactions include, but are not limited to:

  • Flushing
  • Shortness of breath
  • Facial swelling
  • Headache
  • Chills
  • Chest pain
  • Back pain
  • Tightness in the chest or throat
  • Fever
  • Tachycardia
  • Pruritus
  • Rash
  • Cyanosis
  • Syncope
  • Bronchospasm
  • Asthma
  • Apnea
  • Hypotension

Prior to administering DOXIL®, counsel patients to alert you immediately if they are experiencing any of the symptoms of acute infusion-related reactions listed above.

Managing Infusion-Related Reactions

If an infusion-related reaction occurs:

1. Medications to treat anaphylactoid-like infusion reactions, as well as emergency equipment, should
be available.

2. Manage as appropriate (in some patients, the reaction resolved when rate of infusion was slowed).

The majority of infusion-related events occurred during the first infusion of DOXIL®. Similar reactions have not been reported with conventional doxorubicin, and they presumably represent a reaction to the DOXIL® liposomes or to one of its surface components.

Steps to Manage Extravasation

DOXIL® is an irritant, not a vesicant. Please take precautions to avoid extravasation. If extravasation occurs:

1. Immediately stop the infusion.

2. Pack the site of extravasation with ice for 30 minutes.

3. Restart IV in a new vein.