How DOXIL Works
DOXIL is an advanced form of doxorubicin, a liposomal formulation of doxorubicin, which means that doxorubicin is encapsulated by a fatty bilayer. The liposome is pegylated, which helps protect the drug from the immune system, resulting in the product circulating in the blood for a longer period of time. The longer circulation allows dosing once every four weeks.

Administration
DOXIL is administered intravenously in the doctor's office or clinic. Treatment usually takes from 30 minutes to one hour, though the first treatment may be longer.

• To manage adverse events such as PPE, stomatitis, or hematologic toxicity, the dose may be delayed or reduced;
• Pretreatment with or concomitant use of antiemetics should be considered; and
• Limited clinical experience exists in treating hepatically impaired patients with DOXIL. Based on experience with doxorubicin HCl, it is recommended that DOXIL dosage be reduced if the bilirubin is elevated as follows: Serum bilirubin 1.2 to 3.0 mg/dL give normal dose, >3.0 mg/dL give normal dose.

Efficacy
DOXIL's refractory ovarian cancer indication was based on the results of three Phase II trials involving patients with metastatic ovarian cancer that was resistant to conventional chemotherapy. Most of the patients had been treated with two or more rounds of conventional chemotherapy, but the tumor was still progressing.

In these studies, patients with refractory metastatic ovarian cancer treated with DOXIL had a 13.8% (20/145) (95% CI 8.1% to 19.3%) combined response rate. The median time to response was 18 weeks, median duration of response was 39 weeks, and median time to disease progression was 16 weeks.

Warnings
In clinical trials, the most common side effects reported with DOXIL therapy included reduced red blood cel
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8-May-2003