DOXIL - Safety Information

DOXIL—Safety Information

Know the Risks
In the largest clinical study ever conducted in recurrent ovarian cancer, DOXIL was established to be effective and generally well tolerated for ovarian cancer that has recurred or progressed. However, as with any chemotherapy treatment, some serious complications may still occur, including heart-related side effects, infusion-related reactions, changes in blood cell counts, and other side effects such as skin-related reactions.

Heart-Related Side Effects
The use of DOXIL may lead to heart-related side effects. DOXIL should be administered to patients with a history of cardiovascular disease only when the benefit outweighs the risk. In the largest clinical study ever conducted with recurrent ovarian cancer patients, 3.8% of patients treated with DOXIL experienced a heart-related disorder.

Symptoms of heart-related side effects may include:

Irregular heartbeat
Shortness of breath
Fatigue
Ankle swelling

Due to the serious and possibly permanent effects of heart-related side effects, your doctor will closely watch the dosage of DOXIL and any related chemotherapy agents. Notify your doctor or nurse immediately if you experience any of the above symptoms.

Infusion-Related Reactions
Infusion-related reactions were seen in up to 10% of patients treated with DOXIL, so you will be closely observed for reactions during your first infusion. If a reaction occurs, it usually happens during the first infusion. In most patients, infusion-related reactions can be managed by either slowing or stopping the treatment. In clinical studies, less than 1% of DOXIL patients discontinued therapy due to infusion-related reactions. However, some reactions can be severe and may have serious consequences.

A list of the most common infusion-related reactions is provided below. Please let your doctor or nurse know immediately if you experience any of these or other symptoms during your treatment:

Flushed feeling
Dizziness or light-headedness
Shortness of breath
Chills
Back pain
Facial swelling
Tightness in the chest or throat
Headache

Changes in Blood Cell Counts
Chemotherapy treatments can lower blood cell counts, which can cause other unwanted effects:

Reduced white blood cell counts (neutropenia) can lead to fever and infections
Reduced red blood cell counts (anemia) can make you feel tired and fatigued
Reduced platelet counts (thrombocytopenia) can lead to impaired blood clotting and prolonged bleeding

Changes in blood cell counts are generally moderate and reversible in patients treated with DOXIL. But in some patients, severe reductions in blood cell counts may occur. Your doctor or nurse will typically check all of your blood cell counts regularly and may give you medication to bring low blood cell counts back up to the target range during your treatment.

Skin-Related Reactions
Patients who take DOXIL commonly experience skin reactions called hand-foot syndrome (HFS) also known as palmar-plantar erythrodysesthesia (PPE) and/or stomatitis, a mouth irritation characterized by inflammation or sores. These common side effects and how to minimize their severity are explained in detail in the next section.

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GLOSSARY

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).

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