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Cardiac function should be monitored regularly in patients receiving daunorubicin citrate liposome injection 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.
Daunorubicin citrate liposome injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
Dosage should be reduced in patients with impaired hepatic function.
A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with daunorubicin citrate liposome injection in the Phase III clinical trial, and in 2.7% of treatment cycles (27/994). 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 .
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 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Chemical Class: Anthracycline
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 daunorubicin citrate liposome 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.
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 daunorubicin citrate liposome, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to daunorubicin citrate liposome 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.
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.
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 Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies 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. |
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.
Using daunorubicin citrate liposome 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.
Using daunorubicin citrate liposome 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.
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.
The presence of other medical problems may affect the use of daunorubicin citrate liposome. Make sure you tell your doctor if you have any other medical problems, especially:
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.
daunorubicin citrate liposome 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.
The dose of daunorubicin citrate liposome 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 daunorubicin citrate liposome. 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.
It is very important that your doctor check your progress at regular visits to make sure that daunorubicin citrate liposome 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:
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 commonSome 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 commonLiposomal 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.
daunorubicin citrate liposome 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.
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