Understanding DaunoXome® (daunorubicin citrate liposome injection)
Information for US patients, caregivers and healthcare professionals
THIS SITE IS INTENDED FOR US AUDIENCES ONLY
DaunoXome® (daunorubicin citrate liposome injection) is a prescription drug indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma.1 DaunoXome® is not recommended in patients with less than advanced HIV-related Kaposi's sarcoma.1 Please talk to your healthcare professional if you have any questions regarding DaunoXome®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). If you have a medical information inquiry or wish to report a side effect relating to DaunoXome® to the company, call 1-855-DAUNOXOME (1-855-328-669663).
It is the healthcare professional's sole responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered. Coverage, coding, and reimbursement guidelines will vary according to individual insurance plans. Healthcare professionals should contact insurers to verify correct coding procedures prior to submitting claims related to DaunoXome®. In all cases, healthcare professionals will need to follow local payer policies for billing and reimbursement.
For further information please click here to refer to the full DaunoXome® Package Insert.
- DaunoXome® (daunorubicin citrate liposome injection) US Package Insert. Revised December 2011.
IMPORTANT SAFETY INFORMATION
- Cardiac function should be monitored regularly in patients receiving DaunoXome® (daunorubicin citrate liposome injection) because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart.
- Severe myelosuppression may occur.
- DaunoXome® should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
- Dosage should be reduced in patients with impaired hepatic function.
- A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with DaunoXome® in the Phase III clinical trial, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.
- Therapy with DaunoXome® is contraindicated in patients who have experienced a serious hypersensitivity reaction to previous doses of DaunoXome® or to any of its constituents.
Additional Safety Information
- The primary toxicity of DaunoXome® is myelosuppression. Careful hematologic monitoring is required and since patients with HIV infection are immunocompromised, patients must be observed closely for evidence of intercurrent or opportunistic infections.
- Special attention must be given to the potential cardiac toxicity of DaunoXome®. Patients who have received prior therapy with anthracyclines (doxorubicin > 300mg/m2 or equivalent), have pre-existing cardiac disease, or have received previous radiotherapy encompassing the heart may be less “cardiac” tolerant to treatment with DaunoXome®. Monitoring of LVEF at cumulative DaunoXome® doses should occur prior to therapy and every 160mg/m2 of DaunoXome®.
- Daunorubicin has been associated with local tissue necrosis at the site of drug extravasation. Although no such local tissue necrosis has been observed with DaunoXome®, care should be taken to ensure that there is no extravasation of drug when DaunoXome® is administered.
- The safety and effectiveness of DaunoXome® in pediatric and elderly patients have not been established.
- Safety has not been established in patients with pre-existing hepatic or renal dysfunction. Based on experience with conventional daunorubicin hydrochloride, it is recommended that the dosage of DaunoXome® should be reduced in patients with impaired hepatic or renal function; refer to the full Package Insert for details.
- Pregnancy Category D: DaunoXome® can cause fetal harm when administered to a pregnant woman.
- If DaunoXome® is used during pregnancy, or if the patient becomes pregnant while being treated with DaunoXome®, the patient must be warned of the potential hazard to the fetus. Patients should be advised to avoid becoming pregnant while being treated with DaunoXome®.
- DaunoXome® is indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. DaunoXome® is not recommended in patients with less than advanced HIV-related Kaposi's sarcoma.