Mitoxantrone (Intravenous)

Mitoxantrone injection is used in combination with other medicines to treat advanced prostate cancer and acute nonlymphocytic leukemia (ANLL), and treats certain types of multiple sclerosis (MS).


Mitoxantrone is usually given at a hospital or clinic. A nurse or healthcare professional injects it into a vein (intravenous route) of the patient under the supervision of a doctor. The medicine is administered slowly as a free-flowing infusion into the vein.

In the treatment of advanced prostate cancer and nonlymphocytic leukemia (ANLL), Mitoxantrone works by disrupting the activity that causes cancer cells to divide and spread.

In the treatment of multiple sclerosis (MS), the drug slows the growth of cells that cause symptoms of the condition. It also reduces neurologic disability caused by the condition. The medicine is not a cure for multiple sclerosis.

Mitoxantrone may cause heart damage even in patients with no history of heart problems. This can occur during or after treatment and up to years later. The immune system is also affected by the medicine, making it easier for patients to get an infection.

Due to such serious adverse reactions, your doctor may need to perform certain heart tests and assess your body's response to initial treatment.

Mitoxantrone is the generic name for this injection which is marketed in the US under the brand names, Novantrone and OTN Mitoxantrone. Patients are treated with this drug only through a doctor's prescription.

The drug may be used to treat other medical conditions not discussed in this guide.

Conditions Treated

  • Advanced Prostate Cancer
  • Acute Nonlymphocytic Leukemia (ANLL)
  • Multiple Sclerosis (MS).

Type Of Medicine

  • Antineoplastic

Side Effects

Mitoxantrone may cause unwanted side effects that are serious and require immediate medical care. Other side effects may go away on their own.

Patients should pay close attention to their body's response to the medication and know when to seek medical attention.

If you experience any the following side effects, call your doctor or nurse right away:

More commonly occur

  • Pain in the stomach
  • Dizziness
  • Heartbeat that is fast, slow or irregular
  • Bladder pain
  • Cough
  • Burning, pain or difficulty urinating
  • Fainting
  • Increased urge to urinate
  • Pain in the back or lower side
  • Feeling unusually tired or weak
  • Pale skin
  • Black, tarry stools
  • Inflammation or swelling of the mouth
  • Difficulty breathing when energy is exerted
  • Urine that appears cloudy or bloody
  • White spots, ulcers or sores in the mouth
  • Unusual bruising or bleeding
  • Shortness of breath

Less commonly occur

  • Decrease in urination
  • Swelling of the lower legs or feet
  • Pinpoint red spots on the skin
  • (convulsions) seizures
  • Chills or fever
  • Blood in the urine or stools
  • Yellowing of the skin or eye
  • Sore, red eyes

Rarely occur

  • Skin rash
  • Blueish skin at the area where the medicine was injected
  • Redness or pain in the area where the medicine was injected

The following are side effects which may occur but do not need medical attention. They tend to go away on their own as your body gets used to the treatment. However, if you experience any of them and it becomes worse or bothersome, let your doctor or nurse know.

More commonly occur

  • Back pain
  • Stuffy nose
  • Diarrhea
  • Tender, swollen neck glands
  • Heavier or longer menstrual periods
  • Nausea or vomiting
  • Thinning of the hair
  • Bleeding of the mouth
  • Aches or pains about the body
  • Congestion
  • Runny nose
  • Constipation
  • Headache
  • Pain or tenderness of the cheekbones or around the eyes
  • Irregular menstrual periods (including missed or absent periods)
  • Sneezing
  • Hair loss
  • Soreness of dryness of the throat

Side effects not listed in this guide may occur in some patients. Let your doctor or nurse know if you notice any unusual symptoms that bother you or do not go away.

You may also ask your doctor or healthcare professional about ways to reduce or prevent the occurrence of side effects.

You may report side effects by calling the US FDA at 1-800-FDA-1088.


Mitoxantrone generic injection solution should be given slowly as a free-flowing infusion into one of your veins.

It will be administered to you at a hospital or clinic by a nurse or healthcare professional. It is usually done under the direct supervision of a doctor.

Your doctor may direct you to drink plenty of fluids while you are receiving the medicine. This will help flush your kidneys and prevent kidney problems.

Missed dose

If you missed a dose of your medicine, call your doctor right away for instructions.


Drug overdose is unlikely to occur since the medicine is given by a nurse or healthcare professional under direct supervision of a doctor.

If an accidental overdose does occur, you may experience symptoms such as sore throat, unusual weakness, persistent nausea and vomiting, chills, and fever. Call your doctor or nurse right away, 911, and the poison control center at 1-800-222-1222.


Food, alcohol, and tobacco

Sometimes food, alcohol or tobacco may affect the way a medicine works and should not be used around the time you take your medicine. Your doctor will let you know if you should avoid any of them while taking Mitoxantrone.

Other medicines

Apart from food, alcohol, and tobacco other medicines may adversely interact and affect the way this injection works. Below is a list of medicines which may significantly interact with Mitoxantrone.

It is not recommended that you use this medication with any of the following medicines. Your doctor may decide that the potential risks are greater than the benefits of treating you with Mitoxantrone while you are taking any of these other medicines.

Your doctor may still decide to treat you but change one or more of the other medicines you take.

It is usually not recommended that you use the injection with any of the following medicines. If treatment with any of them is necessary while you are taking Mitoxantrone, your doctor may change the dose or how often you use any of your medicines.

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

Other medicines not listed in this guide may also cause adverse interaction. You may speak with your doctor for more information.

Other medical problems

Medical conditions present in patients taking Mitoxantrone may affect or be affected by the medicine. Ensure you tell your doctor about any other medical problems, especially the following conditions. They may cause side effects to worsen.

  • Congestive heart failure
  • Bleeding problems or blood clots
  • Heart or blood vessel disease
  • Bone marrow depression
  • Blood disease (such as anemia or low white blood cell levels)

Patients with the following conditions may have an increased risk of developing severe infections that can affect other areas of the body:

Mitoxantrone may worsen the following conditions if present in patients who are taking the medicine:

Use the medicine with caution in patients who have the following condition. The level of the medicine may rise due to the slow removal of the drug from the patient's body. This may result in increased side effects.


  • Use Mitoxantrone only if your doctor prescribed it to treat your advanced prostate cancer, acute nonlymphocytic leukemia (ANLL) or multiple sclerosis (MS).
  • Do not use this drug if you are allergic to it. Also, tell your doctor if you are allergic to other medicines, foods, dyes, preservatives or animals.
  • Let your doctor know about all prescription or non-prescription medicines, vitamins or herbal products you take or plan to take.
  • Do not use other medications or vaccines during or after treatment before speaking with your doctor.
  • Tell your doctor especially if you are taking or have taken certain cancer chemotherapy medicines such as epirubicin, doxorubicin, idarubicin or daunorubicin. Also let your doctor know if you were previously treated with mitoxantrone.
  • Do not use Mitoxantrone to treat children. Its safety and efficacy have not been established for use in pediatrics.
  • If you are pregnant, may be pregnant or breastfeeding, tell your doctor. There may be a risk of harm to an unborn baby or breastfeeding infant if you take the medicine.
  • Use the medicine with caution in elderly patients to prevent medical problems that may develop due to their age.
  • This medicine may cause some serious side effects or complications that may become fatal. Your doctor should consider your medical history and the potential benefits and risks involved before treating you with this drug.
  • Mitoxantrone may damage a patient's heart during treatment or after. Some patients start having heart problems due to the medicine many years after, which may become fatal.
  • Heart problems have occurred even in patients with no history of a heart condition. Tell your doctor if you have or had any type of heart disease or x-ray of the chest area.
  • Because of the seriousness of heart problems, your doctor will do certain tests before, during and after your treatment. Heart tests such as an electrocardiogram (ECG) and an echocardiogram will likely be done.
  • These are important tests to monitor you for potential or developing heart problems.
  • Your doctor may decide not to treat you with this medication if the results show that your heart is not pumping blood as it should.
  • Call your doctor right away if you have symptoms of a serious heart problem. Symptoms include fast or irregular heartbeat, pain or discomfort in the chest pain, troubled breathing, shortness of breath, or swelling of the feet and lower legs.
  • This medication weakens the immune system making patients vulnerable to infections. Avoid contact with people who are sick or have infections.
  • If you develop symptoms of an infection, such as cough, hoarseness, chills, fever, difficulty urinating, pain while urinating, or pain in your lower back or side, tell your doctor.
  • Persons living in your household should also not receive live virus vaccines such as for measles, mumps, or rubella (MMR) or nasal vaccine for the flu. If they do, they may pass the virus onto you.
  • If it is difficult to avoid contact with these household members who have taken the vaccines, so you should wear a face mask to protect your nose and mouth.
  • Remember to take all your medicines at the right time if you are taking Mitoxantrone in combination with other medicines. You may speak with your doctor for advice on how to properly take your medicines.
  • Nausea and vomiting are common side effects when taking this drug, but you should continue to take it. Let your doctor know of your symptoms and ask about ways to reduce these effects.
  • The medicine will be given by needle into one of your veins by a nurse or other trained health professional at a hospital or clinic. This medicine is given through a needle placed in one of your veins.

If you experience swelling, burning, pain or redness of the skin in the area where the medicine was injected, tell your nurse or doctor immediately.

  • Within 24 hours of receiving the medicine, it is normal for some patients to notice that the white part of their eyes appears bluish-green in color. They may also notice that their urine appears bluish-green in color.
  • The medicine may affect your body's ability to clot blood. To reduce the risk of bleeding and bruising while taking the medication you should take as many precautions as possible.
  • These include being careful to not cut yourself while using sharp objects such as those used to cut fingernails and toenails. Also, use razors with care.
  • Also, avoid activities that may cause bodily contact and increase the chance of bruising or injury. Check with your doctor right away if you notice bleeding or bruising.
  • To prevent bruising and bleeding, your doctor may tell you to use other ways to clean your teeth and gums other than with a toothbrush, dental floss, or dental pick.
  • Let your doctor know if you are planning to visit the dentist or undergo a dental procedure.
  • Prevent this medication from getting into your eyes or onto your skin. If this happens, rinse your eyes with water. Use warm water to rinse your skin. Also, let your doctor know.
  • Keep all appointments with your doctor and lab. Your doctor will need to keep checking you for unwanted side effects and the development of other problems during and after treatment with Mitoxantrone.
  • Do not share this medicine with anyone else, even if they have similar medical conditions or symptoms.


Patients are not required to store this medicine because it is usually stored at a hospital or clinic.


Mitoxantrone effectively treats advanced prostate cancer and acute nonlymphocytic leukemia (ANLL). It also treats certain types of multiple sclerosis (MS), but will not cure it.

The drug is known for causing heart damage during and even long after treatment has ended. Such damage has resulted in death, even in patients who had no previous problem with their heart.

Due to the seriousness of this adverse effect, rigorous heart tests should be done before, during, and after treatment to monitor the patient's heart condition. In some cases, the risk is too high and treatment with Mitoxantrone may be avoided.

This drug lowers the immune system making it more likely for patients to get infections. Bleeding, bruising and blood clotting problems may also occur.

Mitoxantrone is either not safe or should be used with caution in patients who have certain other medical problems. Their doctor is required to consider the potential risks and potential benefits involved before deciding whether to treat them.

Certain medicines and vaccines may cause serious adverse interaction if taken during or after treatment with Mitoxantrone. Patients are expected to be proactive in letting their doctor or nurse know about all medicines and vaccines they take or plan to take.

Because the medicine can continue to seriously affect the body (especially the heart) long after treatment has ended, patients are expected to keep all follow-up appointments for medical tests and assessments.

Last Reviewed:
March 26, 2018
Last Updated:
April 16, 2018