Novantrone Side Effects

Generic name: mitoxantrone

Medically reviewed by Drugs.com. Last updated on Sep 4, 2024.

Note: This document provides detailed information about Novantrone Side Effects associated with mitoxantrone. Some dosage forms listed on this page may not apply specifically to the brand name Novantrone.

Applies to mitoxantrone: intravenous solution.

Precautions

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 (the active ingredient contained in Novantrone) 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:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with 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 careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with 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 careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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.

Serious side effects of Novantrone

Along with its needed effects, mitoxantrone 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 while taking mitoxantrone:

Other side effects of Novantrone

Some side effects of mitoxantrone 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:

For healthcare professionals

Applies to mitoxantrone: intravenous solution.

Hematologic adverse events

• Very common (10% or more): Platelets low (up to 33%), leukopenia (up to 19%), white blood cells low (up to 100%)
• Common (1% to 10%): Myelosuppression (especially leucopenia)
• Uncommon (0.1% to 1%): Thrombocytopenia, anemia
• Frequency not reported: Bone marrow depression^[Ref]

Oncologic

• Frequency not reported: Acute myeloid leukemia (AML), acute myelodysplastic syndrome (AMS)^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 76%), stomatitis (up to 19%), diarrhea (up to 16%), gastralgia/stomach burn/epigastric pain (up to 14%), constipation (up to 10%), aphthosis (up to 10%)
• Common (1% to 10%): Vomiting
• Uncommon (0.1% to 1%): Anorexia, GI bleeding, abdominal pain, altered taste
• Frequency not reported: Mucositis, vomiting^[Ref]

Cardiovascular

• Very common (10% or more): Arrhythmia (up to 18%), ECG abnormal (up to 11%)
• Uncommon (0.1% to 1%): Hypotension
• Frequency not reported: Acute arrhythmias, transient ECG alterations, reduced left ventricular output, cardiac insufficiency, congestive heart failure (CHF)^[Ref]

Local

• Uncommon (0.1% to 1%): Phlebitis, erythema, swelling, pain, burning and/or blue discoloration of the skin
• Rare (less than 0.1%): Tissue necrosis (following extravasation)^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Uncommon (0.1% to 1%): Somnolence, mild paresthesia^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Anaphylaxis^[Ref]

Dermatologic

• Very common (10% or more): Reversible alopecia (up to 61%)
• Uncommon (0.1% to 1%): Urticaria, rash, nail pigmentation, onycholysis^[Ref]

Renal

• Uncommon (0.1% to 1%): Elevated serum creatinine, elevated blood urea nitrogen
• Frequency not reported: Renal failure^[Ref]

Hepatic

• Very common (10% or more): Gamma-glutamyl transpeptidase increased (up to 15%)
• Common (1% to 10%): Alanine aminotransferase (ALT or SGPT) increased, aspartate aminotransferase (AST or SGOT) increased, granulocytopenia, anemia
• Uncommon (0.1% to 1%): Increased liver enzyme levels, elevated bilirubin levels^[Ref]

Other

• Very common (10% or more): Asthenia (up to 24%)
• Uncommon (0.1% to 1%): Fever, fatigue, weakness^[Ref]

Genitourinary

• Very common (10% or more): Menstrual disorder (including amenorrhea) (up to 61%), urinary tract infection (up to 32%), abnormal urine (up to 11%)
• Common (1% to 10%): Menorrhagia
• Frequency not reported: Blue-green coloration of the urine 1 to 2 days after administration^[Ref]

Endocrine

• Frequency not reported: Amenorrhea^[Ref]

Immunologic

• Very common (10% or more): Infection (e.g., tonsillitis, enteritis, urinary tract infection, viral infection, endometritis) (up to 85%), cutaneous mycosis (up to 10%)^[Ref]

Metabolic

• Very common (10% or more): Glucose high (up to 10%), potassium low (up to 10%)
• Common (1% to 10%): Back pain
• Rare (less than 0.1%): Tumor lysis syndrome (characterized by hyperuricemia, hypercalcemia, hyperphosphatasemia, hypocalcemia)^[Ref]

Ocular

• Uncommon (0.1% to 1%): Reversible blue coloration of the sclera
• Frequency not reported: Lethargy, fatigue, seizures^[Ref]

Psychiatric

• Frequency not reported: Depression^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 53%), pharyngitis/throat infection (up to 19%), rhinitis (up to 10%)
• Common (1% to 10%): Sinusitis
• Uncommon (0.1% to 1%): Dyspnea, pneumonitis^[Ref]

See also:

Further information

Novantrone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer