DOXIL Injectable By BAXTER ACC

See also Warning section. Body aches/pains, headache, nausea, vomiting, constipation, diarrhea, stomach upset, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects. If any of these effects continue or worsen, notify your doctor or pharmacist. This medication may give a reddish-orange color to your urine, tears, and sweat. This is a normal effect of the drug and should not be mistaken for blood in your urine. Temporary hair loss may occur. Normal hair growth should return several months after treatment has ended. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). Notify your doctor promptly if you experience swelling, pain, redness, dryness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may give you something to reduce the symptoms, or decrease or delay your next dose of liposomal doxorubicin. Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), drowsiness, trouble sleeping, mental/mood changes (e.g., anxiety, confusion, depression), cough/hoarseness, redness/pain/swelling of arms/legs, eye redness/itching, painful/difficult urination, stomach/abdominal pain, yellowing of the skin/eyes, dark urine, black/tarry stools, bloody mucus or discharge in stools, vision changes (e.g., blindness), fast/irregular heartbeat. This medication may cause certain severe (rarely fatal) blood disorders (bone marrow suppression leading to low red blood cells/white blood cells /platelets). This can lower your body's ability to fight infection and stop bleeding. Tell your doctor right away if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual tiredness, or easy bleeding/bruising.) Painful swelling or sores on the lips, mouth and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water. Get medical help right away if this rare but very serious side effect occurs: chest pain. Within days to weeks after doxorubicin treatment, a serious skin reaction that looks likes a severe sunburn (radiation recall) may develop on any area of skin that has been previously treated with radiation. Tell your doctor right away if you develop skin redness, pain, tenderness, swelling, peeling, or blisters. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling. Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors. In children, radiation recall may occur in the lungs. Tell the doctor right away if you notice wheezing or trouble breathing in the child. Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia, oral cancer). Your risk is greater if you have received this medication long-term (more than 1 year), or with certain types of chemotherapy or radiation treatment. Consult your doctor for more details. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.