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Novantrone Side Effects

Generic Name: mitoxantrone

Note: This page contains side effects data for the generic drug mitoxantrone. It is possible that some of the dosage forms included below may not apply to the brand name Novantrone.

For the Consumer

Applies to mitoxantrone: intravenous solution

As well as its needed effects, mitoxantrone (the active ingredient contained in Novantrone) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking mitoxantrone, check with your doctor or nurse immediately:

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

Severity: Minor

Some mitoxantrone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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

It is possible that some side effects of Novantrone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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