Novantrone

DRUG DESCRIPTION

NOVANTRONE® (mitoxantrone hydrochloride) is a synthetic antineoplastic anthracenedione for intravenous use. The molecular formula is C22H28N4O6•2HCl and the molecular weight is 517.41. It is supplied as a concentrate that MUST BE DILUTED PRIOR TO INJECTION. The concentrate is a sterile, nonpyrogenic, dark blue aqueous solution containing mitoxantrone hydrochloride equivalent to 2 mg/mL mitoxantrone free base, with sodium chloride (0.80% w/v), sodium acetate (0.005% w/v), and acetic acid (0.046% w/v) as inactive ingredients. The solution has a pH of 3.0 to 4.5 and contains 0.14 mEq of sodium per mL. The product does not contain preservatives. The chemical name is 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl) amino]ethyl]amino]-9,10anthracenedione dihydrochloride and the structural formula is:

NOVANTRONE®
(mitoxantrone hydrochloride) Structural Formula Illustration

What are the possible side effects of mitoxantrone (Novantrone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, mouth sores, unusual weakness;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • pain or...

Read All Potential Side Effects and See Pictures of Novantrone »

What are the precautions when taking mitoxantrone for injection concentrate (Novantrone)?

Before using mitoxantrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), liver disease, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of...

Read All Potential Precautions of Novantrone »


Novantrone Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, headache, or unusual tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Severe nausea, vomiting, or diarrhea may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.

Temporary hair thinning/loss may occur. Normal hair growth should return after treatment has ended.

This medication may cause your urine to turn blue-green. The white part of your eyes may also turn a bluish color. These effects are temporary, normal, and harmless.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds), numbness/tingling feelings, seizure.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mitoxantrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), liver disease, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Before you start treatment with this medication, your doctor may direct you to have a pregnancy test. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Novantrone Patient Information Including Side Effects

Brand Names: Novantrone

Generic Name: mitoxantrone (Pronunciation: mye toe ZAN trone)

  • What is mitoxantrone (Novantrone)?
  • What are the possible side effects of mitoxantrone (Novantrone)?
  • What is the most important information I should know about mitoxantrone (Novantrone)?
  • What should I discuss with my healthcare provider before receiving mitoxantrone (Novantrone)?
  • How is mitoxantrone given (Novantrone)?
  • What happens if I miss a dose (Novantrone)?
  • What happens if I overdose (Novantrone)?
  • What should I avoid while receiving mitoxantrone (Novantrone)?
  • What other drugs will affect mitoxantrone (Novantrone)?
  • Where can I get more information?

What is mitoxantrone (Novantrone)?

Mitoxantrone is a cancer medication that interferes with cancer cells and slows their growth and spread in the body. Mitoxantrone also affects the immune system.

Mitoxantrone is used to treat prostate cancer and certain types of leukemia.

Mitoxantrone is also used to treat the symptoms of relapsing multiple sclerosis. This medication will not cure multiple sclerosis.

Mitoxantrone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mitoxantrone (Novantrone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, mouth sores, unusual weakness;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • pain or burning when you urinate;
  • urinating more or less than usual;
  • chest pain or tightness, trouble breathing;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds; or
  • skin changes where the medicine was injected.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, constipation, stomach pain;
  • depressed mood;
  • missed menstrual periods;
  • tired feeling;
  • blue-green colored urine or a bluish color of the whites of the eyes for a few days after each dose;
  • headache; or
  • thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mitoxantrone (Novantrone)?

You should not use this medication if you are allergic to mitoxantrone.

Before receiving this medication, tell your doctor if you have ever received it in the past, or if you have heart disease, congestive heart failure, a weak immune system, any type of infection, a bleeding or blood-clotting disorder; a blood cell disorder, liver disease, or if you have ever been treated with daunorubicin (Cerubidine, Daunoxome) or doxorubicin (Adriamycin, Rubex, Doxil).

Do not receive mitoxantrone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Your may need a pregnancy test to make sure you are not pregnant before you receive each injection of mitoxantrone.

Mitoxantrone can cause your urine to turn a blue-green color. You may also notice a bluish discoloration of the whites of your eyes. This side effect should last only a few days and is not harmful.

Mitoxantrone can lower blood cells that help your body fight infections. Your blood will need to be tested on a regular basis. Avoid being near people who have contagious illnesses. Contact your doctor at once if you develop signs of infection.

Mitoxantrone can also cause serious heart damage. Your heart rate will need to be checked using an electrocardiograph or ECG (sometimes called an EKG) before, during, and after your treatment with mitoxantrone. Do not miss any scheduled appointments. The effects of mitoxantrone on your heart could be long-lasting.

You must remain under the care of a doctor while receiving mitoxantrone.

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