- May 6, 2022
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Brand Name :
Novantrone
Synonyms :
mitoxantrone
Class :
Anthracenedione, Antineoplastics, Multiple Sclerosis Treatment
Dosage Forms & Strengths
Injectable Solution
2mg/ml
12-14 mg/m2 intravenous every 21 days for three weeks when combined with corticosteroids
Indicated for Multiple Sclerosis, Secondary Progressive:
12 mg/m² short intravenous infusion (5-15 minutes) for three months. Do not exceed 140mg/m2
Induction therapy: On days 1 through 3, administer 12 mg/m2 once a day (in addition to 100 mg/m2 of cytarabine given as a continuous intravenous infusion on days 1 through 7)
Second Induction Therapy: On days 1 and 2, inject 12 mg/m2 (combined with a continuous 24-hour intravenous infusion of cytarabine on days 1 through 5)
Consolidation: Day 1 and Day 2 IV administration of 12 mg/m2. The first course is typically delivered six weeks after the last introductory course, while the second is delivered four weeks later.
Safety and efficacy not established
Refer adult dosing
may decrease the diagnostic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the neutropenic effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of anti-neoplastic agents
may decrease the therapeutic effect of anti-neoplastic agents
may increase the toxic effect of anti-neoplastic agents
may decrease the therapeutic effect of immunosuppressants
may decrease the myelosuppressive effect of myelosuppressive agents
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the toxic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the toxic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may increase the myelosuppressive effect of myelosuppressive agents
may decrease the therapeutic effect of immunosuppressants
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
It may enhance the effect when combined with tafamidis meglumine
when both drugs are combined, there may be an increased risk or severity of adverse effects
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may reduce the therapeutic effect of typhoid Vaccine
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may decrease the serum concentration
may decrease the serum concentration
Actions and Spectrum:
Frequency defined
>10%
Upper respiratory infection (51%)
Urinary tract infection (29%)
Amenorrhea (28%)
Stomatitis (15%)
Nausea (55%)
Alopecia (38%)
Diarrhea (25%)
Constipation (14%)
1-10%
Back pain (6%)
Headache (6%)
Frequency Not Defined
Cardiotoxicity
Hepatotoxicity
Decreased left ventricular ejection fraction
Myelosuppression
Abnormal LFT’s
Black box warning:
Contraindications/caution:
Contraindications:
mitoxantrone has several contraindications, including:
Caution:
In addition to the contraindications mentioned earlier, several cautions should be considered when using mitoxantrone:
Pregnancy consideration: mitoxantrone can harm the fetus and is contraindicated in pregnant women
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
Pharmacodynamics:
The pharmacodynamics of mitoxantrone involves its ability to interfere with DNA replication and repair by binding to the DNA molecule and inhibiting the activity of topoisomerase II, an enzyme that helps in the separation of DNA strands during replication and repair. mitoxantrone induces cell cycle arrest by interfering with DNA synthesis and repair and ultimately leads to cell death.
Pharmacokinetics:
Absorption
mitoxantrone has poor oral bioavailability, meaning it is not well absorbed orally. As a result, it is usually administered intravenously.
Distribution
mitoxantrone is highly lipophilic and can readily penetrate cell membranes, including the blood-brain barrier, which allows it to be effective against some types of brain tumors. It is extensively distributed throughout the body, with a volume of distribution of >1000 L/m² or 14 L/kg.
Metabolism
mitoxantrone is metabolized in the liver by combining phase I and II reactions. The primary metabolic pathway involves the formation of several hydroxylated metabolites, which are less cytotoxic than the parent compound. The metabolites are excreted in the bile and eliminated in the feces.
Elimination and Excretion
The elimination of mitoxantrone occurs primarily through feces (about 25%) and urine (about 11%). The elimination half-life of mitoxantrone is approximately 23 hours, which means that it takes about 23 hours for half of the drug to be eliminated from the body.
Administration:
Patient information leaflet
Generic Name: mitoxantrone
Pronounced: [ mye-toe-ZAN-trone ]
Why do we use mitoxantrone?
mitoxantrone is a chemotherapy drug used to treat several types of cancer and some non-cancerous conditions. Some of the primary uses of mitoxantrone include:
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