Liposomal doxorubicin may cause heart problems, including possibly fatal heart failure. Heart problems may occur during liposomal doxorubicin therapy or months to years after receiving this medication. Your risk of developing heart problems depends on your dose, medical history (including previous heart disease, radiation therapy in the chest area), and previous use of this and other drugs (including daunorubicin and cyclophosphamide). Children are at higher risk and should be monitored later in life for delayed heart problems. See also Side Effects section.

This medication may cause certain severe 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 immediately if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual tiredness, or easy bleeding/bruising.

While this drug is first being given into your vein, this medication may cause severe (rarely fatal) reactions, including allergic reactions. Tell your doctor immediately if you experience flushing, trouble breathing, swelling of the face, tightness in the chest/throat, chills, back pain, severe dizziness, or fast heartbeat. See also Side Effects section.

Tell your doctor if you have liver problems because the dose may need to be decreased.

Your doctor will closely monitor you while you are being treated with this medication.

Different types of this medication work in different ways. Do not switch types of this medication without your doctor's permission.

Liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used alone or with other treatments/medications to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat breast cancer.

This medication is given by injection into a vein over 30-60 minutes or longer by a health care professional. Before injecting each dose, clean the injection site with rubbing alcohol. The injection should start slowly (1 milligram or less per minute) to decrease the risks from possible serious reactions. This medication should not be injected into a muscle or beneath the skin. Notify your doctor immediately if redness, pain, or swelling occur at or near the injection site.

The dosage is based on your medical condition, body size, and response to therapy.

Follow all instructions for proper mixing, dilution with the correct IV fluids, and injection. The final product should be hazy and reddish in color. Before using, check this medication visually for particles. If particles are present, do not use the liquid. Do not use an in-line filter when giving this medication. If you have questions regarding the use of this medication, consult the pharmacist.

If this medication touches your skin, immediately and completely wash skin with soap and water. If this medication gets in your eye, open the eyelids and flush with plenty of water for 15 minutes. Seek immediate medical attention.

Family members and caregivers should take precautions (e.g., wear gloves) to prevent contact with the patient's urine or other body fluid for at least 5 days after treatment. Learn how to store and discard needles, medical supplies and medical waste safely. Consult your pharmacist.

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.

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.

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.

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.

Temporary hair loss may occur. Normal hair growth should return several months after treatment has ended.

Tell your doctor immediately if any of these unlikely but serious side effects occur: drowsiness, trouble sleeping, mental/mood changes (e.g., anxiety, confusion, depression), cough/hoarseness, redness/pain/swelling of arms/legs, eye redness/itching, unusual tiredness, swelling of ankles/feet, painful/difficult urination, stomach/abdominal pain, yellowing of the skin/eyes, dark urine.

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.

Tell your doctor immediately if any of these rare but very serious side effects occur: black/tarry stools, bloody mucus or discharge in stools, vision changes (e.g., blindness), fast/irregular heartbeat, shortness of breath.

Seek immediate medical attention 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 immediately 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 immediately 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 (e.g., secondary leukemia). Your risk is greater if you have received certain types of chemotherapy or radiation therapy. Consult your doctor for more details.

A very serious allergic reaction to this drug is unlikely, but fatal reactions have rarely occurred. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, which may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using liposomal doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to doxorubicin; or to other drugs containing polyethylene glycol; or to lincomycin; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of receiving your total maximum dose of any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, gout, heart problems, infection, liver problems, radiation treatment (especially to the chest area), kidney problems, a certain immune system problem (neutropenia), low platelet count (thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised if using liposomal doxorubicin in children because they may be more sensitive to its effects, especially on the heart.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) while being treated with this medication and for some time afterward. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: calcium channel blockers (e.g., verapamil, nifedipine), cyclosporine, digoxin, progesterone, phenobarbital, phenytoin, streptozocin, stavudine, zidovudine.

Avoid eating foods or products containing turmeric (curcumin) while being treated with liposomal doxorubicin. It may decrease this medication's effects. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unexplained bleeding.

Laboratory and/or medical tests (e.g., complete blood counts, heart studies, liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Keep all your medical and laboratory appointments.

For the most benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

Before mixing, refrigerate the dry powder between 36-46 degrees F (2-8 degrees C) in the original container. Protect from light. Do not freeze. Once prepared, this medication may be refrigerated and should be used within 24 hours.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.