Novantrone (mitoxantrone hydrochloride)
Novantrone® (mitoxantrone hydrochloride) is a synthetic anticancer agent for intravenous use. Novantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS). This kind of MS is characterized by gradually increasing disability and those whose neurologic status is significantly abnormal between relapses. Novantrone is not indicated for treatment of primary progressive multiple sclerosis.
What are the ingredients in Novantrone?How does Novantrone work?
Novantrone is a chemotherapy medication used as a disease-modifying drug (DMD) to reduce the number of MS relapses. It suppresses the body’s immune system during treatment and depletes the number of cells that attack myelin around the nerves. This therapy gives the body a chance to rest and repair.
What are the possible side effects of Novantrone?
Many clinical trials evaluated the safety and efficacy of Novantrone. The most common side effects experienced by those taking Novantrone include:
- Nausea and vomiting
- Hair thinning
- Loss of menstrual periods
- Bladder infections
- Mouth sores
If you have trouble breathing, experience swelling of legs or ankles, or uneven or fast heartbeat, call 911 immediately. These problems generally happen in people who receive a lifetime dose of more than 12 doses but can also occur at lower lifetime doses.
Novantrone may reduce white blood cell count, which increases the chance of getting an infection. It may also cause your platelet count to go down, which increases the chance of bleeding; this is why regular blood tests are conducted. Call the doctor if you experience fever, chills, sore throat, cough, pain with urination, urination more often, or if you notice any unusual bleeding or bruising.
Things to note about Novantrone
Patients with MS may experience changes in cardiac function when treated with Novantrone. Before initiating therapy everyone should have a cardiac assessment including taking a history, physical examination, ECG, and quantitative LVEF (Left ventricular ejection fraction) evaluation. People with a baseline LVEF below the lower limit of normal should not be treated with Novantrone.
A complete blood count including platelets, and liver function tests, should be obtained prior to each course of Novantrone, and if signs of infection develop.
Novantrone and its metabolites are excreted in the bile and urine. It may cause a blue-green color to the whites of your eyes (sclera) and the urine for 24 hours after administration.
Before starting Novantrone, talk with your doctor if you have:
- A preexisting myelosuppression (reduction of bone marrow activity) as the result of prior drug therapy
- Been treated with certain medications that can affect cardiac toxicity
- Abnormal liver function
- Planned to become pregnant, as it is generally not recommended while on Novantrone
- A history of hypersensitivity or allergic reaction to mitoxantrone hydrochloride.
This is not an exhaustive list of all potential side effects of Novantrone. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Novantrone, contact your doctor or healthcare provider immediately.
Novantrone is supplied to medical facilities as a concentrate and must be diluted prior to injection. The recommended dosage of Novantrone is 12 mg/m2 given and should be given slowly into a freely flowing IV infusion every 3 months. Cumulative lifetime dose should not exceed 140 mg/m2.
For additional details, read the full prescribing information of Novantrone.
- NOVANTRONE prescribing information is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf Accessed 4/15/18.