Information regarding infusion-related reactions1
Keep medications to treat serious, life-threatening, and fatal infusion reactions and emergency equipment to treat such reactions available for immediate use during infusions.
- Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation of DOXIL®
Rapid infusion may increase the risk of infusion-related reactions; 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®.
In the event of an infusion-related reaction, temporarily stop the drug until resolution, then resume at a reduced infusion rate. Discontinue DOXIL® infusion for serious or life-threatening infusion-related reactions.
In clinical trials, 11% of patients with solid tumors treated with DOXIL® experienced 1 or more acute infusion-related reactions such as:
- Shortness of breath
- Facial swelling
- Chest pain
- Back pain
- Tightness in the chest or throat
Serious, life-threatening, and fatal infusion reactions have been reported.
How to manage extravasation1
Discontinue DOXIL® for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation.
Manage confirmed or suspected extravasation as follows:
- Do not remove the needle until attempts are made to aspirate extravasated fluid
- Do not flush the line
- Avoid applying pressure to the site
- Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days
- If the extravasation is in an extremity, elevate the extremity
Instruct patients to alert you and your team of healthcare professionals if they:
- Develop any symptoms of heart failure (cardiomyopathy)
- Experience discoloration (reddish-orange color) of urine and other body fluids
- Experience a burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation
- Develop a fever or symptoms of infection (myelosuppression)
- Experience tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (hand-foot syndrome)
- Develop painful redness, swelling, or sores in the mouth (stomatitis)
- Suspect that they may be pregnant, or may become pregnant during treatment with DOXIL®
- Advise patients not to breastfeed during treatment with DOXIL®
- Advise females and males of reproductive potential to use effective contraception during and for 6 months following treatment with DOXIL®, and that treatment with DOXIL® may cause temporary or permanent infertility
Advise patients about the symptoms of infusion-related reactions and to seek immediate medical attention if they develop any of these symptoms.
DOXIL® (doxorubicin HCl liposome injection) Prescribing Information. Janssen Products, LP, Horsham, PA.