MitoXANTRONE should be given slowly into a freely flowing IV infusion and must never be given subQ, IM, 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 1500 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 (cardiac signs/symptoms and left ventricular ejection fraction (LVEF)) in all patients during therapy. Patients with multiple sclerosis (MS) who have a baseline LVEF below the lower limit of normal should not receive mitoXANTRONE. Monitor MS patients for cardiac function prior to each dose. Do not give additional doses if clinically significant drop in LVEF during treatment and do not administer a cumulative dose greater than 140 mg/m(2) in MS patients. When mitoXANTRONE therapy is withdrawn, late-occurring cardiotoxicity should be evaluated on an annual basis in MS patients. MitoXANTRONE therapy in MS patients and in cancer patients increases the risk of developing secondary acute myeloid leukemia .
Mitoxantrone injection is used alone or together with other medicines to treat advanced prostate cancer and acute nonlymphocytic leukemia (ANLL). It belongs to the group of medicines known as antineoplastics or cancer medicines. Mitoxantrone is also used to treat some forms of multiple sclerosis (MS). This medicine will not cure MS, but it may extend the time between relapses.
Mitoxantrone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by mitoxantrone, other unwanted 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 unwanted effects may not occur for months or years after the medicine is used.
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.
This medicine 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 injection 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 injection in the elderly. However, elderly patients are more likely to have age-related medical problems, which may require caution in patients receiving mitoxantrone.
|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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
Other medical problems
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:
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 or cancer clinic. This medicine is given through a needle placed in one of your veins.
If you have pain, burning, redness, or swelling of your skin area where the needle is placed, tell your doctor or nurse right away.
If this medicine gets on your skin, rinse the area well with warm water and tell your doctor. If the medicine gets in your eyes, rinse your eyes with large amounts of water, and tell your doctor.
While you are receiving mitoxantrone, your doctor may want you to drink extra fluids so 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. 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 right away if you are having chest pain or discomfort; fast or irregular heartbeats; 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 a bluish-green color. 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 (vaccines) 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 receive live virus vaccines (eg, nasal flu vaccine, measles, mumps, or rubella) since there is a chance they could pass the virus to you. Also, avoid persons who have received live virus vaccines. 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.
Check with your doctor or nurse immediately if any of the following side effects occur:
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:
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.