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Novantrone Side Effects

Generic Name: mitoxantrone

Medically reviewed by Drugs.com. Last updated on Oct 3, 2020.

Note: This document contains side effect information about mitoxantrone. Some of the dosage forms listed on this page may not apply to the brand name Novantrone.

For the Consumer

Applies to mitoxantrone: intravenous solution

Warning

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 When mitoXANTRONE therapy is withdrawn, late-occurring cardiotoxicity should be evaluated on an annual basis in MS patients.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

Side effects requiring immediate medical attention

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

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

Side effects not requiring immediate medical attention

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

  • 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

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]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Novantrone (mitoxantrone)." Immunex Corporation, Seattle, WA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.