Frequently Asked Questions about Cerubidine® (Daunorubicin)
Generic Name: Daunorubicin (don-ah-ROO-bi-sin), daunorubicin hydrochloride, daunomycin, rubidomycin hydrochloride
Trade Name: Cerubidine®
For which conditions is Cerubidine® approved for? Cerubidine is FDA approved in combination with other anticancer agents for the treatment of acute myelogenous leukemia and acute lymphocytic leukemia. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Cerubidine belongs to a class of drugs called anthracycline antitumor antibiotics. Cerubidine produces its anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining life of a cell.
How is Cerubidine typically given (administered)? Cerubidine is administered intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient. During administration, if Cerubidine escapes from the vein in which it is being given, it can cause serious damage to tissues that it may come in contact with. Although patients will be monitored for this, patients should notify their healthcare provider immediately if they experience pain, redness or swelling at the area of intravenous administration.
How are patients typically monitored? Patients will usually have scheduled meetings during treatment with Cerubidine to assess side effects and response to therapy. Typically, blood will be drawn to determine levels of blood cells, electrolytes, and monitor function of metabolism and some organs such as the liver and kidneys. Heart function will be monitored prior to treatment and possibly during treatment, as Cerubidine may cause damage to the heart. Physical examinations, scans and other measures to assess response and tolerance to therapy may also be utilized.
Patients will also be monitored for a possible allergic reaction to Cerubidine, either during or immediately following administration. Patients who experience difficulty breathing, rash, hives, wheezing, closing of the throat, or swelling of facial features should notify their healthcare provider immediately.
What are the common (occur in 30% or more of patients) side effects of treatment with Cerubidine?
• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia or blood transfusions
• Low platelet levels – increases risk of bleeding
• Nausea and vomiting
• Mouth sores
• Reddish or orange colored urine
• Abnormal heart rhythm
• Hair loss
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Cerubidine?
What are the rare (occur in less than 10% of patients) side effects of treatment with Cerubidine?
• Darkening of skin or nails
What are possible late side effects of treatment with Cerubidine?
Patients who are treated with Cerubidine may experience side effects months or years following treatment. A rare, but serious side effect that may occur years following treatment with Cerubidine is damage to the heart. Patients that have been treated with Cerubidine may also develop leukemia as a second cancer. Patients should discuss these side effects with their physician.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Treatment with Cerubidine may make patients more sensitive to sunlight. Patients should wear light clothing, hats, sunglasses and sunscreen when exposed to sunlight.
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting chemotherapy?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Sore throat
• Flu or cold-like symptoms
• Signs of infection – redness, swelling, pus, tenderness, painful or more frequent than usual urination
• Blistering or severe pain/redness/swelling at administration site
• Persistent and severe fatigue
• Unexplained bleeding (nosebleeds, bruises, black tarry stools, blood in the urine, etc.)
• Persistent or severe nausea and vomiting
• Persistent diarrhea
• Mouth sores
• Signs of an allergic reaction – wheezing, difficulty breathing, hives, rash, closing of throat
• Noticeable changes in heart rate or rhythm
• Chest pain
• Difficulty breathing
• Abdominal pain
• Yellowing of skin or eyes
• Swelling of ankles or feet
• Darkening or redness of skin where radiation has been given
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.