Novantrone (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 certain types of multiple sclerosis (MS). This medicine will not cure MS, but it may help increase the time between relapses.

Mitoxantrone works by interfering with the growth of cancer cells, which are eventually destroyed. It may also affect the growth of normal body cells, leading to other unwanted effects. Some of these effects can be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but can still 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 associated with it.

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

It is very important for your doctor to check your progress at regular visits to ensure 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 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 the medicine, tell your doctor right away. Your doctor may also require you to have a pregnancy test before you receive each dose of this medicine to ensure you are not pregnant.

Contact your doctor immediately if you experience chest pain or discomfort; fast or irregular heartbeats; shortness of breath; swelling of the feet and lower legs; or troubled breathing. These may be signs 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 receiving the medicine.

While you are being treated with mitoxantrone, and after you stop treatment, do not have any immunizations (vaccines) without your doctor's approval. Mitoxantrone may lower your body's resistance, and there is a chance you could get the infection the immunization is meant to prevent. Additionally, people living in your household should not receive live virus vaccines (e.g., nasal flu vaccine, measles, mumps, or rubella) because they could potentially pass the virus to you. Also, avoid close contact with people who have received live virus vaccines. 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 your risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are some 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 getting an infection or if you develop 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 urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your medical 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 the meantime.
• Be cautious when using sharp objects, such as safety razors or fingernail or toenail clippers, to avoid cuts.
• 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. 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 healthcare 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 performed on the relationship of age to the effects of mitoxantrone injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies done so far have not shown geriatric-specific problems 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 in patients receiving mitoxantrone.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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.

• 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 drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change 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 problems, 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, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Contact your doctor or nurse right away if any of the following side effects happen:

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 injection site
• Pain or redness at the injection site
• Skin rash

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your healthcare professional may be able to inform you about ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects persist, 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.

Contact your doctor for medical advice about side effects. You can 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.