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Daunorubicin citrate liposome (Intravenous route)

Pronunciation:

daw-noe-ROO-bi-sin SIT-rate LYE-poh-some

Brand Names:

  • Daunoxome

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Cardiac function should be monitored regularly because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart. Severe myelosuppression may occur and dosage should be reduced in patients with impaired hepatic function. A triad of back pain, flushing, and chest tightness has been reported with administration. This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

Anthracycline

Uses of This Medicine:

Liposomal daunorubicin 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Trastuzumab
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • 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

Proper Use of This Medicine:

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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 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.

Side Effects of This Medicine:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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