DAUNORUBICIN,LIPOSOMAL (Systemic)?

Some commonly used brand names are:

In the U.S.?

• DaunoXome

? Not commercially available in Canada.

Category

• Antineoplastic

Description

Liposomaldaunorubicin (LIP-oh-som-al daw-noe-ROO-bi-sin)belongs to the general group of medicines known as antineoplastics. It isused to treat advanced acquired immunodeficiency syndrome (AIDS)-associatedKaposi'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 alsomay be affected by liposomal daunorubicin, other effects will occur. Someof 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 maynot occur until months or years after the medicine is used.

Before you begin treatment with liposomal daunorubicin, you and your doctorshould talk about the good this medicine will do as well as the risks of usingit.

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

Parenteral
• Injection (U.S.)

Before Receiving This Medicine

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

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

Pregnancy?Liposomal daunorubicin has not been studied in pregnantwomen. However, studies in rats have shown that liposomal daunorubicin atlow doses causes birth defects or death of the fetus.

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

Breast-feeding?Because liposomal daunorubicin may cause seriousside effects in the infant, breast-feeding is generally not recommended whileyou are receiving it.

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

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingliposomal daunorubicin, it is especially important that your health care professionalknow 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?Liposomaldaunorubicin may increase the effects of these medicines or radiation therapyon the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Liposomal daunorubicin mayraise the concentration of uric acid in the blood. Since these medicines areused to lower uric acid levels, they may not be as effective in patients receivingliposomal daunorubicin

Other medical problems?The presence of other medicalproblems may affect the use of liposomal daunorubicin. Make sure you tellyour doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

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

• Heart disease?Risk of heart problems caused by liposomal daunorubicinmay be increased

• Infection?Liposomal daunorubicin can decrease your body's abilityto fight infection

• Kidney disease or
• Liver disease?Effects of liposomal daunorubicin may be increasedbecause of slower removal from the body

Proper Use of This Medicine

Liposomaldaunorubicin is sometimes given together with certain other medicines. Ifyou are using a combination of medicines, it is important that you receiveeach one at the proper time. If you are taking some of these medicines bymouth, ask your health care professional to help you plan a way to take themat the right times.

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

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

Dosing?The dose of liposomal daunorubicin will bedifferent for different patients. The dose that is used may depend on a numberof 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'sorders or the directions on the label. If you have any questions aboutthe proper dose of liposomal daunorubicin, ask your doctor.

Precautions While Using This Medicine

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 forunwanted effects.

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

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

• If you can, avoid people with infection. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycan occur.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif 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; troubledbreathing; weakness or numbness in arms or legs

Less common

Black, tarry stools; blood in urineor 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; unusualbleeding or bruising; unusual nighttime urination; unusual tiredness or weakness; weight gain

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof 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; bleedinggums; constipation; difficultyswallowing; 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 siteof injection; tooth pain; uncomfortable swelling around anus; uncontrollablemovement of body

Symptoms of overdose

Liposomal daunorubicincauses the urine to turn reddish in color, which may stain clothes. This isnot blood. It is to be expected and only lasts for 1 or 2 days after eachdose is given.

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

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