OTN Mitoxantrone (Intravenous)

Mitoxantrone injection is used alone or with other medicines to treat advanced prostate cancer and acute nonlymphocytic leukemia (ANLL). It is part of a group of medicines called antineoplastics or cancer medicines. Mitoxantrone is also used to treat some types of multiple sclerosis (MS). This medicine will not cure MS, but it may help lengthen the time between relapses.

Mitoxantrone works by interfering with the growth of cancer cells, which are eventually destroyed. The growth of normal body cells may also be affected by mitoxantrone, leading to other unwanted effects. Some of these effects may be serious and should be reported to your doctor. Other effects, like hair loss, may not be serious but can be concerning. Some unwanted effects may not appear for months or years after using the medicine.

Before starting treatment with mitoxantrone, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

This medicine must be given only by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood tests and heart function tests may be needed to check for unwanted effects.

You should not receive this medicine if you are pregnant. Using this medicine while pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, tell your doctor right away. Your doctor may also require a pregnancy test before you receive each dose of this medicine to ensure you are not pregnant.

Contact your doctor immediately if you are experiencing chest pain or discomfort; fast or irregular heartbeats; shortness of breath; swelling of the feet and lower legs; or difficulty breathing. These could be signs of a serious heart problem.

This medicine may change your urine color to a 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, do not receive any immunizations (vaccines) without your doctor's approval. Mitoxantrone may lower your body's resistance, increasing the chance of getting the infection the immunization is meant to prevent. Additionally, others in your household should not receive live virus vaccines (e.g., nasal flu vaccine, measles, mumps, or rubella) since they could transmit the virus to you. Also, avoid people who have received live virus vaccines. Keep your distance and do not stay in the same room with them for long. If you cannot take these precautions, consider wearing a protective face mask that covers your nose and mouth.

Mitoxantrone can temporarily lower the number of white blood cells in your blood, increasing the risk of 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 possible, avoid people with infections. Contact your doctor immediately if you think you are developing an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other methods to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in between.
• Be careful not to cut yourself when using sharp objects such as a safety razor or nail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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.

Pediatric

Appropriate studies have not been done on the relationship of age to the effects of mitoxantrone injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies performed to date have not shown geriatric-specific issues that would limit the usefulness of mitoxantrone injection in older adults. However, older patients are more likely to have age-related medical issues, which may require caution when using mitoxantrone.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

While some 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 situations, your doctor may need to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Valspodar
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Eltrombopag

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. 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 issues, especially:

• Blood clots or bleeding problems or
• Blood disease (e.g., anemia, low white blood cell counts) or
• Bone marrow depression or
• Congestive heart failure or
• Heart or blood vessel disease—May cause side effects to become worse.

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles) or
• Infections—There is an increased risk of severe infections affecting other parts of the body.

• Gout, history of or
• Kidney stones—May worsen these conditions.

• Liver disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• cough or shortness of breath
• difficult, burning, or painful urination
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• frequent urge to urinate
• lower back or side pain
• pale skin
• stomach pain
• swelling or inflammation of the mouth
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blood in the urine or stools
• decrease in urination
• fever or chills
• pinpoint red spots on the skin
• seizures
• sore, red eyes
• swelling of the feet and lower legs
• yellow eyes or skin

Rare

• Blue skin at the place of injection
• pain or redness at the place of injection
• skin rash

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

• Absent, missed, or irregular menstrual periods
• back pain
• body aches or pains
• congestion
• constipation
• diarrhea
• dryness or soreness of the throat
• hair loss
• headache
• longer or heavier menstrual periods
• nausea or vomiting
• oral bleeding
• pain or tenderness around the eyes and cheekbones
• runny nose
• sneezing
• stopping of menstrual bleeding
• stuffy nose
• tender, swollen glands in the neck
• thinning of the hair

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.

In the U.S.

• Novantrone
• OTN Mitoxantrone

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

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.