In the U.S.—

• Antineoplastic

Liposomal daunorubicin (LIP-oh-som-al daw-noe-ROO-bi-sin) belongs to the general group of medicines known as antineoplastics. It is used to treat advanced acquired immunodeficiency syndrome (AIDS)–associated Kaposi's sarcoma (KS), a kind of skin cancer.

Liposomal daunorubicin seems to interfere with the growth of cancer cells, which eventually are destroyed. Since the growth of normal body cells also may be affected by liposomal daunorubicin, other effects will occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with liposomal daunorubicin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Liposomal daunorubicin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For liposomal daunorubicin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to liposomal daunorubicin. Also, tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Liposomal daunorubicin has not been studied in pregnant women. However, studies in rats have shown that liposomal daunorubicin at low doses causes birth defects or death of the fetus.

Before receiving this medicine, make sure your doctor knows if you are pregnant or may become pregnant. It is best to use some kind of birth control while you are receiving liposomal daunorubicin. Tell your doctor right away if you think you have become pregnant while receiving liposomal daunorubicin.

Breast-feeding—Because liposomal daunorubicin may cause serious side effects in the infant, breast-feeding is generally not recommended while you are receiving it.

Children—There is no specific information comparing the use of liposomal daunorubicin in children with use in any other age group. Safety and efficacy of liposomal daunorubicin in children have not been established.

Older adults—There is no specific information comparing the use of liposomal daunorubicin in the elderly with use in any other age group. Safety and efficacy of liposomal daunorubicin in the elderly have not been established.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking liposomal daunorubicin, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Liposomal daunorubicin may increase the effects of these medicines or radiation therapy on the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Liposomal daunorubicin may raise the concentration of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not be as effective in patients receiving liposomal daunorubicin

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones—Liposomal daunorubicin may increase uric acid in the body, which can cause gout or kidney stones

• Heart disease—Risk of heart problems caused by liposomal daunorubicin may be increased

• Infection—Liposomal daunorubicin can decrease your body's ability to fight infection

• Kidney disease or
• Liver disease—Effects of liposomal daunorubicin may be increased because of slower removal from the body

Liposomal daunorubicin is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving liposomal daunorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive it even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of liposomal daunorubicin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving liposomal daunorubicin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of liposomal daunorubicin, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with liposomal daunorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Liposomal daunorubicin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral poliovirus vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Liposomal daunorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury can occur.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Cough or hoarseness;  fever or chills ;  lower back or side pain;  painful or difficult urination;  shortness of breath ;  sore throat;  troubled breathing;  weakness or numbness in arms or legs 
  
  

• Less common
  • Black, tarry stools;  blood in urine or stools;  bloody vomit;  chest pain;  coughing up blood;  fainting;  fast heartbeat;  irregular heartbeat;  pinpoint red spots on skin;  producing large amounts of pale, dilute urine;  sores in mouth and on lips;  swelling of abdomen, face, fingers, hands, feet, or lower legs;  unusual bleeding or bruising;  unusual nighttime urination ;  unusual tiredness or weakness;  weight gain 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal pain;  back pain;  chest tightness;  diarrhea;  feeling unusually cold;  flushing;  headache;  nausea and vomiting;  shivering;  skin rash or itching 
  
  

• Less common
  • Bleeding after defecation;  bleeding gums;  constipation;  difficulty swallowing;  dizziness;  dry mouth;  dry, irritated, itching, or red eyes;  extreme feeling of sleepiness;  eye pain ;  frequent urge to defecate;  pain in joints or muscles;  pain at site of injection ;  painful, red, hot, or irritated hair follicles ;  red, hot, or irritated skin at site of injection ;  ringing sound in ears;  sleeplessness;  swelling or lump under skin at site of injection;  tooth pain;  uncomfortable swelling around anus;  uncontrollable movement of body 
  
  

• Symptoms of overdose
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness;  fever or chills;  lower back or side pain;  painful or difficult urination;  pinpoint red spots on skin;  sore throat;  sores in mouth and on lips;  unusual bleeding or bruising  
  
  

Liposomal daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with liposomal daunorubicin has ended, normal hair growth should return.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.