Generic Name: mitoxantrone (Intravenous route, Injection route)
Mitoxantrone for injection concentrate should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents.
Mitoxantrone should be given slowly into a freely flowing intravenous infusion. It must never be given subcutaneously, intramuscularly, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration.
Not for intrathecal use. Severe injury with permanent sequelae can result from intrathecal administration.
Except for the treatment of acute nonlymphocytic leukemia, mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm(3). In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving mitoxantrone.
Cardiotoxicity: Congestive heart failure (CHF), potentially fatal, may occur either during therapy with mitoxantrone or months to years after termination of therapy. Cardiotoxicity risk increases with cumulative mitoxantrone dose and may occur whether or not cardiac risk factors are present. Presence or history of cardiovascular disease, radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or use of other cardiotoxic drugs may increase this risk. In cancer patients, the risk of symptomatic CHF was estimated to be 2.6% for patients receiving up to a cumulative dose of 140 mg/m(2). To mitigate the cardiotoxicity risk with mitoxantrone, prescribers should consider the following:
All patients should be assessed for cardiac signs and symptoms by history, physical examination, and ECG prior to start of mitoxantrone therapy.
All patients should have a baseline quantitative evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (ex. Echocardiogram, multi-gated radionuclide angiography (MUGA), MRI, etc.).
MS patients with a baseline LVEF below the lower limit of normal should not be treated with mitoxantrone.
MS patients should be assessed for cardiac signs and symptoms by history, physical examination and ECG prior to each dose.
MS patients should undergo quantitative reevaluation of LVEF prior to each dose using the same methodology that was used to assess baseline LVEF. Additional doses of mitoxantrone should not be administered to multiple sclerosis patients who have experienced either a drop in LVEF to below the lower limit of normal or a clinically significant reduction in LVEF during mitoxantrone therapy.
MS patients should not receive a cumulative mitoxantrone dose greater than 140 mg/m(2).
MS patients should undergo yearly quantitative LVEF evaluation after stopping mitoxantrone to monitor for late occurring cardiotoxicity.
Secondary acute myelogenous leukemia (AML) has been reported in multiple sclerosis and cancer patients treated with mitoxantrone. In a cohort of mitoxantrone treated MS patients followed for varying periods of time, an elevated leukemia risk of 0.25% (2/802) has been observed. Postmarketing cases of secondary AML have also been reported. In 1,774 patients with breast cancer who received mitoxantrone concomitantly with other cytotoxic agents and radiotherapy, the cumulative risk of developing treatment-related AML, was estimated as 1.1% and 1.6% at 5 and 10 years, respectively. Secondary acute myelogenous leukemia (AML) has been reported in cancer patients treated with anthracyclines. Mitoxantrone is an anthracenedione, a related drug.
The occurrence of refractory secondary leukemia is more common when anthracyclines are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated .
Mitoxantrone should be given slowly into a freely flowing intravenous infusion and must never be given subcutaneously, intramuscularly, or intra-arterially. Not for intrathecal use; severe injury with permanent sequelae can result from intrathecal administration. Except for the treatment of acute nonlymphocytic leukemia, therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm(3). Cardiotoxicity, potentially fatal, has been associated with treatment. Presence or history of cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Monitor cardiac function during therapy. Secondary acute myelogenous leukemia (AML) has been reported in multiple sclerosis and cancer patients treated with mitoxantrone .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Mitoxantrone belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancer. It is also used to treat some forms of multiple sclerosis (MS). This medicine will not cure MS, but may extend the time between relapses.
Mitoxantrone 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 mitoxantrone, 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.
Mitoxantrone is used together with other medicines to treat advanced hormone-refractory prostate cancer. It is also used to treat acute nonlymphocytic leukemia (ANLL) in some patients.
Before you begin treatment with mitoxantrone, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
Mitoxantrone 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 this medicine, the following should be considered:
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.
Appropriate studies have not been performed on the relationship of age to the effects of mitoxantrone in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mitoxantrone in the elderly.
|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 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.
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.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain mitoxantrone. It may not be specific to OTN Mitoxantrone. Please read with care.
Mitoxantrone 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 doctor to help you plan a way to take them at the right times.
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for up to 15 minutes.
If this medicine gets on your skin, rinse the area well with warm water and tell your caregiver. If the medicine gets in your eyes, rinse your eyes with large amounts of water, and tell your caregiver.
While you are receiving mitoxantrone, 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.
Mitoxantrone often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if your stomach is upset. Ask your doctor for ways to lessen these effects.
This medicine comes with a patient package insert. Read and follow the information carefully. Ask your doctor if you have any questions.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests and tests for your heart function may be needed to check for unwanted effects.
You should not receive this medicine if you are pregnant or breastfeeding. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Also, your doctor may require you to have a pregnancy test before you receive each dose of this medicine, to make sure you are not pregnant.
Check with your doctor immediately if you are having chest pain or discomfort, fast or irregular heartbeat, shortness of breath, swelling of the feet and lower legs, or troubled breathing. These could be symptoms of a serious heart problem.
This medicine may change the color of your urine to bluish-green. The whites of your eyes may also appear slightly bluish-green. This is normal, especially within the first 24 hours after you receive the medicine.
While you are being treated with mitoxantrone, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Mitoxantrone 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.
Mitoxantrone 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:
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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.
Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
Check with your doctor or nurse immediately 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
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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