This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area), and previous use of this and other drugs (including doxorubicin). Tell your doctor right away if you notice symptoms such as very fast/irregular heartbeat, shortness of breath, or swelling ankles/feet.
Daunorubicin may cause certain severe blood and bone marrow disorders (low red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection. Tell your doctor right away if you develop easy bleeding/bruising or signs of infection (e.g., fever, chills, persistent sore throat).
Very rarely, people with cancer who are treated with this type of medication have developed other cancers (e.g., secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs or radiation treatment. Consult your doctor for more details.
This medication may cause symptoms including back pain, flushing, and chest tightness, usually during the first 5 minutes of injection into a vein. If you notice any of these symptoms, tell your doctor or nurse right away. If the injection is temporarily stopped and then given more slowly, the symptoms will not usually return.Who should not take Daunoxome Vial?
If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.
If this medication touches your skin, immediately wash the area well with soap and water. Caregivers should take precautions (e.g., wear gloves) to prevent contact with the patient's urine and other body fluids.
Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (e.g., increased uric acid).
See also Warning section.
Nausea, vomiting, constipation, diarrhea, loss of appetite, dry mouth, headache, dry/flaking skin, flushing, and increased sweating may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: hearing changes, mental/mood changes (e.g., confusion, unusual thoughts/behavior, depression), muscle problems (e.g., stiff/painful muscles, shaking, unusual urge to keep moving), nerve problems (e.g., numbness/tingling/pain), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).
Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
Get medical help right away if this rare but very serious side effect occurs: seizure.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using daunorubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).
Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially effects on the heart.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Before having surgery, tell your doctor or dentist that you are using this medication.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (e.g., kidney/liver function tests, complete blood count, EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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