Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m(2) in adults, 300 mg/m(2) in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age.
Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
Dosage should be reduced in patients with impaired hepatic or renal function .
Must be given into a rapidly flowing intravenous infusion and must never be given by the intramuscular or subcutaneous route as severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m(2) in adults, 300 mg/m(2) in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. Dosage should be reduced in patients with impaired hepatic or renal function .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Chemical Class: Anthracycline
Daunorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancer.
Daunorubicin seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by daunorubicin, other effects will also 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 for months or years after the medicine is used.
Before you begin treatment with daunorubicin, you and your doctor should talk about the good daunorubicin will do as well as the risks of using it.
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, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to daunorubicin 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.
Although daunorubicin is used in children, there is no specific information comparing use in children with use in other age groups.
Heart problems are more likely to occur in the elderly, who are usually more sensitive to the effects of daunorubicin. The elderly may also be more likely to have blood problems.
|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 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 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. Make sure you tell your doctor if you have any other medical problems, especially:
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 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 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 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. 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 is working properly and to check for unwanted effects.
While you are being treated with daunorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. 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 polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio 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 mouth.
Daunorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an 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 daunorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.
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 immediately if any of the following side effects occur:Less common
Check with your doctor as soon as possible if any of the following side effects occur:More common
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
Daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is perfectly normal and lasts for only 1 or 2 days after each dose is given.
daunorubicin often causes a temporary and total loss of hair. After treatment with daunorubicin has ended, normal hair growth should return.
After you stop using daunorubicin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
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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