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Novantrone 20mg/10ml Vial
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Indications & Clinical Uses
- Novantrone (mitoxantrone) 20 mg/10 mL (2 mg/mL concentrate) is a cytotoxic anti-cancer drug of the anthracenedione class, given only by intravenous infusion under the supervision of a physician experienced with cytotoxic chemotherapy; it must never be given as an injection into a vein, muscle, artery, or the spinal fluid.
- It is approved in the United States for initial combination chemotherapy of acute nonlymphocytic leukemia in adults, for pain related to advanced hormone-refractory prostate cancer, and separately for reducing neurologic disability and relapse frequency in worsening relapsing-remitting, secondary progressive, or progressive-relapsing multiple sclerosis.
- Because of its heart and blood-cancer risks, it is generally reserved for people with highly active disease when other treatments have not worked.
- Mitoxantrone is also supplied under other brand and generic names; this information reflects the Novantrone label together with a current generic mitoxantrone label used for cross-check.
Side Effects
- Novantrone carries a boxed warning.
- It can cause potentially fatal congestive heart failure, which may occur during treatment or months to years after it stops, and the risk rises with the total lifetime dose; for multiple sclerosis the cumulative dose must not exceed 140 mg/m2, and heart function (LVEF) must be checked before every dose.
- It can also cause secondary leukemia, which has developed in patients treated for both multiple sclerosis and cancer, sometimes years later.
- Very common reactions in MS patients include nausea (up to 76%), hair loss (61%), and menstrual disorders or amenorrhea (up to 61%); infections such as urinary and upper respiratory tract infections are also common.
- Severe bone marrow suppression with a higher infection risk is expected and requires frequent blood counts.
- Get emergency help for chest pain, breathlessness, irregular heartbeat, unusual bruising or bleeding, or fever, since these can signal heart, marrow, or leukemia complications.
Precautions & Warnings
- Novantrone must be given by slow intravenous infusion only into a free-flowing IV line; it must never be given intrathecally (into the spinal fluid), as this has caused severe, sometimes fatal, nerve injury, and it must never be given by injection into a muscle or artery because of severe local tissue damage.
- Left ventricular ejection fraction must be assessed before starting treatment, before every dose thereafter, and periodically for years after stopping, because heart damage can be delayed.
- It is contraindicated in people with known hypersensitivity to mitoxantrone.
- It can harm a developing fetus, so effective contraception is needed during and after treatment, and it should not be used while breastfeeding.
- Liver problems and active infections should be discussed with the prescribing team before treatment.
- Blood counts, including white cells and platelets, are monitored closely throughout therapy because of the risk of severe, prolonged bone marrow suppression.
Avoid Interactions
- Combining Novantrone with other drugs that damage the heart (such as anthracyclines like doxorubicin) or with prior chest radiotherapy increases the risk of cardiotoxicity, so cumulative exposure from all such treatments is tracked.
- Using it with other bone-marrow-suppressing chemotherapy or radiotherapy increases the risk of severe infection and bleeding from low blood counts.
- Live vaccines should be avoided during and for some time after treatment because the weakened immune system can allow the vaccine strain to cause disease; inactivated vaccines may also work less well.
- Novantrone must not be mixed in the same syringe or infusion with other medicines, particularly heparin, because it can form a precipitate.
- Tell the treating team about all prescription and over-the-counter medicines, herbal products, and any planned vaccinations before each cycle.
References
Frequently Asked Questions
Novantrone (mitoxantrone) is a chemotherapy drug used for acute leukemia, pain from advanced prostate cancer, and worsening forms of multiple sclerosis. It is given only by IV infusion in a hospital or clinic, reserved for cases where other treatments have not controlled the disease.
Novantrone is given as a slow intravenous infusion by a healthcare professional, never as a direct injection into a vein, muscle, artery, or spinal fluid. Dosing depends on the condition treated and blood counts, with lifetime dose capped at 140 mg/m2 for MS.
Yes. Novantrone's boxed warning covers potentially fatal congestive heart failure, which can appear years after treatment ends, and a risk of secondary leukemia. Heart function is checked before every infusion, and lifetime cumulative dosing is strictly limited to reduce these risks.
Common effects include nausea, hair loss, menstrual changes or amenorrhea, and infections linked to low blood counts. The serious risks are heart failure and secondary leukemia. Report chest pain, breathlessness, irregular heartbeat, unusual bleeding or bruising, or fever to your care team immediately.
Before every infusion, you need a heart function test, such as an echocardiogram or MUGA scan, plus blood cell counts. Heart monitoring continues yearly for a long period after your last dose, since Novantrone-related heart damage can develop months or years after treatment stops.
No. Novantrone can seriously harm a developing fetus, so effective contraception is required during treatment and for a period afterward, and breastfeeding should be avoided. Tell your care team immediately if you become pregnant, or think you may be pregnant, while receiving mitoxantrone.
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