Novantrone Side Effects

Generic name: mitoxantrone

Medically reviewed by Drugs.com. Last updated on Apr 16, 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.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

MitoXANTRONE should be given slowly into a freely flowing IV infusion and must never be given subQ, IM, or intra-arterially.

Not for intrathecal use; severe injury with permanent sequelae can result from intrathecal administration.

Except for the treatment of acute nonlymphocytic leukemia, therapy generally should not be given to patients with baseline neutrophil counts of less than 1500 cells/mm(3).

Cardiotoxicity, potentially fatal, has been associated with treatment.

Presence or history of cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity.

Monitor cardiac function (cardiac signs/symptoms and left ventricular ejection fraction (LVEF)) in all patients during therapy.

Patients with multiple sclerosis (MS) who have a baseline LVEF below the lower limit of normal should not receive mitoXANTRONE.

Monitor MS patients for cardiac function prior to each dose.

Do not give additional doses if clinically significant drop in LVEF during treatment and do not administer a cumulative dose greater than 140 mg/m(2) in MS patients.

When mitoXANTRONE therapy is withdrawn, late-occurring cardiotoxicity should be evaluated on an annual basis in MS patients.

MitoXANTRONE therapy in MS patients and in cancer patients increases the risk of developing secondary acute myeloid leukemia.

Serious side effects of Novantrone

Along with its needed effects, mitoxantrone (the active ingredient contained in Novantrone) 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:

More common side effects

• 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 side effects

• 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 side effects

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

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:

More common side effects

• 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

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]

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