DOXIL - Efficacy

DOXIL—Efficacy

DOXIL is approved by the Food and Drug Administration for patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

The largest clinical study ever conducted in recurrent ovarian cancer established the potential benefits and tolerability profile of DOXIL therapy. For patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy, DOXIL was shown to shrink tumors and delay progression of tumors in some patients with recurrent ovarian cancer.

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Doxil (doxorubicin HCl), is a prescription medicine that is administered intravenously by your healthcare professional. DOXIL is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

Please read Important Safety Information below, and talk to your healthcare professional to learn more about DOXIL.

Important Safety Information

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL. Inform your doctor of any history of heart disease, radiation to your chest, or prior chemotherapy. Your doctor may monitor your heart function.
Infusion reactions may occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life threatening, though they are rarely fatal.

DOXIL may severely reduce the number of blood cells (red blood cells, white blood cells, and platelets) in your body. Your doctor may adjust or delay your dose of DOXIL if this occurs.

Your doctor may adjust your dose of DOXIL if you have liver problems.

You should not take DOXIL if you are nursing. If you are pregnant or are planning to become pregnant, inform your doctor.

You should not take DOXIL if you are allergic to doxorubicin HCI or the components of DOXIL.

The most common side effects of DOXIL are:

Hand-Foot Syndome (HFS): Tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet
Stomatitis: Painful redness, swelling, or sores in the mouth
Fever: A fever of 100.5^oF or higher
Neutropenia: Low white blood cell count
Nausea, vomiting, tiredness, weakness, rash, shortness of breath, or mild hair loss
Loss of appetite
Diarrhea

Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL and will go away as the drug leaves the body.

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).

Please click here for full Product Information in PDF format,for more details.